DRG HYBRiD XL® - Is Now FDA Approved in the U.S

Hybrid-XL FDA exempt for Class I
 

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

Z

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
Z

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 LIMS-ASTM, ASTM-LIS Server Software via UDP protocol

Calibration

  • Barcoded Master Curve
  • 2 Point Recalibration
  • 28 Days Stability

Test Principle

  • Enzyme Immunoassays
  • Clinical Chemistry
  • Immunoturbidimetry
N

Handling/Interface

  • LCD Touchscreen Monitor (8.5 inch.)
  • CAN Bus Communication Protocol
  • Smart User Guidance
  • Bi-directional LIMS-ASTM, ASTM-LIS Server Software via UDP protocol

Calibration

  • Barcoded Master Curve
  • 2 Point Recalibration
  • 28 Days Stability

Test Principle

  • Enzyme Immunoassays
  • Clinical Chemistry
  • Immunoturbidimetry
g

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
g

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 – May 2020

Black – Immunoassay (Special ELISA)
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 (coming soon)
CE, FDA
CE, FDA
CE, FDA
CE, FDA
CE, FDA
CE, FDA
CE
CE, FDA
CE, FDA
CE, FDA
CE
CE
CE
Prenatal Supervision Certification
HYE-5359 Beta hCG
HYE-5337 AFP
HYE-5351 Free Estriol
CE
CE
CE, FDA
Endocrinology – Thyroid Function Certification
HYE-5356 T3, free
HYE-5357 T4, free
HYE-5385 TSH
HYE-5697 T3 (under design change)
HYE-5698 T4
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
Diabetes Certification
HYC-5325 HbA1c
HYE-5361 Insulin
CE
CE, FDA
Cardiac Markers Certification
HYC-5321 D-dimer
HYC-5613 CRP-HS
CE
CE
Cardiac Acute Phase Certification
HYC-5613 CRP-HS CE

FDA – Product is FDA Class I 510(k) exempt
CE (without FDA) – product is RUO in the USA

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 PSA (pending on certification)
HYE-5382 TM-CA 72-4
CE
CE
CE
CE
CE
Bone Metabolism Certification
HYE-5334 25-OH Vitamin D (total) CE
Gastrointestinal Disease Certification
HYC-5319 CRP
HYE-5767 Calprotectin
HYE-6123 Pancreatic Elastase
CE
CE
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
Iron Metabolism & Anemia Certification
HYE-5769 Hepcidin 25 (bioactive)
HYC-5319 CRP
CE
CE
Saliva Diagnostic Certification
HYE-5344 Salivary Cortisol CE
Fecal Diagnostic Certification
HYE-5767 Calprotectin
HYE-6123 Pancreatic Elastase
CE
CE
Adrenal Gland Certification
HYE-5343 Cortisol
HYE-5344 Salivary Cortisol
CE
CE
Fully Automated Random Access Analyzer for the Simultaneous Measurement of Immunoassays and Clinical Chemistry

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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