DRG:HYBRiD.XL® - Is Now FDA Approved in the U.S
DRG:HYBRiD.XL® – Fully Automated Analyzer for Enzyme Immunoassays & Clinical Chemistry
DRG International, Inc. is pleased to announce that we have received FDA confirmation classifying our Hybrid XL® for U.S. diagnostic testing.
HYBRID XL: Now FDA exempt for Class I
We now offer our DRG: Hybrid-XL® Automated Analyzer as Class I 510(k) Exempt under product code JJQ along with a collection of our Hybrid XL Tests. Our compact, bench-top instrument offers you freedom to create individual assay panels for routine, as well as dedicated testing.
Click here for more information about this user-friendly, state of the art analyzer.
Watch a Full Demonstration Video of the FDA Approved Hybrid-XL®
Using innovative and unique technology the DRG HYBRiD-XL® allows, for the first time, the simultaneous measurement of immunoassays and clinical chemistry parameters, including turbidimetric tests in one sample.
Up to 40 tests of different types or 40 times of the same test, or up to 40-patient samples can be ordered by the medical practitioner over a wide range of pre-packaged tests to serve different specialties.
Watch a Full Demonstration Video of the FDA Approved Hybrid-XL®
Using innovative and unique technology the DRG HYBRiD-XL® allows, for the first time, the simultaneous measurement of immunoassays and clinical chemistry parameters, including turbidimetric tests in one sample.
Up to 40 tests of different types or 40 times of the same test, or up to 40-patient samples can be ordered by the medical practitioner over a wide range of pre-packaged tests to serve different specialties.
DRG HYBRiD-XL® Specifications
General Specifications
- Benchtop Analyzer 23.6” (H) x 23.6” (W) x 24.8” (D), 125.7 lbs.
- Noise Level <= 70 dB
- Number of Available Wavelengths: 12
- Disposable Measurement Cuvettes
- Closed System
Calibration
- Barcoded Master Curve
- 2 Point Recalibration
- 28 Days Stability
Samples/Cartridges
- 3 Primary Sample holders with 12 sample tubes each (ø13 mm, ø16 mm) or
- 2 Secondary Sample holders with 20 secondary tubes each (ø8 mm)
- Reagents on board (ready to use cartridges)
- Barcoded reading of samples & reagents
- Serum, Plasma, Urine, Saliva & Stool samples
- Minimum sample volume 5 µL
(for tubes ø8 mm) - Minimum dead volume 60 µL
(300 µL for primary tubes) - Sample onboard pre-dilution up to 1:1000
Handling/Interface
- LCD Touchscreen Monitor (8.5 inch.)
- CAN Bus Communication Protocol
- Smart User Guidance
- Bi-directional LIS communication using custom protocol based on UDP. Please contact [email protected] for details.
Test Principle
- Enzyme Immunoassays
- Clinical Chemistry
- Immunoturbidimetry
Efficiency
- Up to 40 samples or 40 tests at once,
one test per cartridge - Assay dependent walk away time 10, 60, 90, 120, 150 minutes (plus 15 minutes warm up time)
- System reagents: Wash solution, Needle cleaning, System solution (purified water)
- Liquid level detection and Clot detection
- Assay sizes (40, 80 tests per box)
- Automated test assignment via LIMS-ASTM protocol
General Specifications
- Benchtop Analyzer 23.6” (H) x 23.6” (W) x 24.8” (D), 125.7 lbs.
- Noise Level <= 70 dB
- Number of Available Wavelengths: 12
- Disposable Measurement Cuvettes
- Closed System
Handling/Interface
- LCD Touchscreen Monitor (8.5 inch.)
- CAN Bus Communication Protocol
- Smart User Guidance
- Bi-directional LIS communication using custom protocol based on UDP. Please contact [email protected] for details.
Calibration
- Barcoded Master Curve
- 2 Point Recalibration
- 28 Days Stability
Test Principle
- Enzyme Immunoassays
- Clinical Chemistry
- Immunoturbidimetry
Samples Cartridges
- 3 Primary Sample holders with 12 sample tubes each (ø13 mm, ø16 mm) or
- 2 Secondary Sample holders with 20 secondary tubes each (ø8 mm)
- Reagents on board (ready to use cartridges)
- Barcoded reading of samples & reagents
- Serum, Plasma, Urine, Saliva & Stool samples
- Minimum sample volume 5 µL (for tubes ø8 mm)
- Minimum dead volume 60 µL (300 µL for primary tubes)
- Sample onboard pre-dilution up to 1:1000
Efficiency
- Up to 40 samples or 40 tests at once, one test per cartridge
- Assay dependent walk away time 10, 60, 90, 120, 150 minutes (plus 15 minutes warm up time)
- System reagents: Wash solution, Needle cleaning, System solution (purified water)
- Liquid level detection and Clot detection
- Assay sizes (40, 80 tests per box)
- Automated test assignment via LIMS-ASTM protocol
Available Assays – October 2024
Orange – Clinical Chemistry (Immunoturbidimetry)
FDA – Product is FDA Class I 510(k) exempt
CE (without FDA) – product is RUO in the USA
| Endocrinology – Gynecology | Certification |
|---|---|
| HYE-5333 17-OH Progesterone HYE-5339 Androstenedione HYE-5346 DHEA HYE-5347 DHEA-S HYE-5349 Estradiol HYE-5355 FSH HYE-5359 Beta hCG HYE-5362 LH HYE-5368 Progesterone HYE-5369 Prolactin HYE-5376 Testosterone HYE-5378 Free Testosterone HYE-5770 AMH |
CE, FDA CE, FDA CE, FDA CE, FDA CE, FDA CE, FDA CE CE, FDA CE, FDA CE, FDA CE CE CE |
| Adrenal Gland | Certification |
|---|---|
| HYE-5343 Cortisol | CE |
| Endocrinology – Thyroid Function | Certification |
|---|---|
| HYE-5356 T3, free HYE-5357 T4, free HYE-5385 TSH HYE-5698 T4 HYE-5697 T3 |
CE, FDA CE CE CE CE |
| Diabetes | Certification |
|---|---|
| HYC-5325 HbA1c HYE-5361 Insulin |
CE CE, FDA |
| Cardiac Markers | Certification |
|---|---|
| HYC-5321 D-dimer HYC-5613 CRP-HS |
CE CE |
| Prenatal Supervision | Certification |
|---|---|
| HYE-5359 Beta hCG HYE-5337 AFP HYE-5351 Free Estriol |
CE CE CE, FDA |
| Iron Metabolism & Anemia | Certification |
|---|---|
| HYE-5769 Hepcidin 25 (bioactive) HYC-5319 CRP |
CE CE |
| Bone Metabolism | Certification |
|---|---|
| HYE-5334 25-OH Vitamin D (total) | CE |
FDA – Product is 510(k) exempt
CE (without FDA) – product is RUO in the USA
| Antibiotic Therapeutic Drug Monitoring | Certification |
|---|---|
| HYE-6166 CeftazidimeNEW HYE-6165 CiprofloxacinNEW HYE-6163 LinezolidNEW HYE-6164 PiperacillinNEW HYC-6210 ProcalcitoninNEW |
CE CE CE CE CE |
| Hypertension | Certification |
|---|---|
| HYE-5338 Aldosterone HYE-5373 Renin (active) |
CE CE |
| Oncology & Tumor markers | Certification |
|---|---|
| HYE-5337 AFP HYE-5359 Beta hCG HYE-5370 PSA HYE-5371 Free PSANEW HYE-5382 TM-CA 72-4 |
CE CE CE CE CE |
| Gastroenterology – Celiac Disease | Certification |
|---|---|
| HYE-5767 Calprotectin HYE-5819 Anti-DGP IgA HYE-5820 Anti-DGP IgG HYE-5894 Anti-tTG IgA HYE-5895 Anti-tTG IgG HYE-6123 Pancreatic Elastase |
CE CE CE CE CE CE |
| Gastrointestinal Disease | Certification |
|---|---|
| HYC-5319 CRP HYE-5767 Calprotectin HYE-6123 Pancreatic Elastase |
CE CE CE |
| Saliva Diagnostic | Certification |
|---|---|
| HYE-5344 Salivary Cortisol | CE |
| Nephrology & Renal Function | Certification |
|---|---|
| HYC-5320 Cystatin C HYE-5343 Cortisol HYE-5347 DHEA-S HYE-5769 Hepcidin 25 (bioactive) |
CE CE CE, FDA CE |
| Fecal Diagnostic | Certification |
|---|---|
| HYE-5767 Calprotectin HYE-6123 Pancreatic Elastase |
CE CE |
We’ve had an excellent run with the DRG Hybrid XL in our lab space. The platform is compact, the interface is concise, the assays are robust, and the results are precise. Coming from a CLIA laboratory, I’ve had the opportunity to handle a number of tabletop and full-size chemistry analyzers. Put simply, the Hybrid is among the best.
~ Julian O. Yerkes Biomarkers Lab, Emory University
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