VITROS CHEMISTRY PRODUCTS BENZ REAGENT, CALIBRATOR KIT 26, FS CALIBRATOR 1 AND DAT PERFORMANCE VERIFIERS I, II, III, IV
Device Facts
| Record ID | K062285 |
|---|---|
| Device Name | VITROS CHEMISTRY PRODUCTS BENZ REAGENT, CALIBRATOR KIT 26, FS CALIBRATOR 1 AND DAT PERFORMANCE VERIFIERS I, II, III, IV |
| Applicant | Ortho-Clinical Diagnostics, Inc. |
| Product Code | JXM · Clinical Toxicology |
| Decision Date | Dec 22, 2006 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.3170 |
| Device Class | Class 2 |
Intended Use
VITROS Chemistry Products BENZ Reagent is used on VITROS 5.1 FS Chemistry Systems for the semi-quantitative or qualitative determination of benzodiazepines (BENZ) in human urine using a cutoff of either 200 ng/mL or 300 ng/mL. Measurements obtained with the VITROS BENZ method are used in the diagnosis and treatment of benzodiazepines use or overdose. The VITROS Chemistry Products BENZ assay is intended for use by professional laboratory personnel. It provides only a preliminary test result. A more specific alternative chemical method must be used to confirm a result obtained with this assay. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drugof-abuse test result, particularly when evaluating a preliminary positive result. VITROS Chemistry Products Calibrator Kit 26 is used to calibrate VITROS 5,1 FS Chemistry Systems for the qualitative or semi-quantitative measurement of drugs of abuse. VITROS Chemistry Products FS Calibrator 1 is used in conjunction with VITROS Chemistry Products Calibrator Kits to calibrate VITROS 5,1 FS Chemistry Systems. VITROS Chemistry Products DAT Performance Verifiers are assayed controls used to monitor performance of urine drugs of abuse screening assays on VITROS 5,1 FS Chemistry Systems.
Device Story
VITROS BENZ assay is a homogeneous enzyme immunoassay for detecting benzodiazepines in human urine. Performed on VITROS 5,1 FS Chemistry Systems by professional laboratory personnel. Input: urine sample; Reagent 1 (antibody to diazepam, G6P, NAD); Reagent 2 (diazepam labeled with G6P-DH). Principle: competition between benzodiazepines in sample and enzyme-labeled diazepam for antibody binding sites. Enzyme activity decreases upon binding; concentration of benzodiazepines is directly proportional to measured enzyme activity. Active enzyme converts NAD to NADH, causing absorbance change measured spectrophotometrically at 340 nm. Output: semi-quantitative or qualitative benzodiazepine concentration. Used for preliminary screening; results require GC/MS confirmation. Clinical decision-making relies on professional judgment and confirmatory testing. Benefits include rapid, automated screening for drug use or overdose.
Clinical Evidence
No clinical trials; performance validated via bench testing comparing VITROS BENZ assay on VITROS 5,1 FS Chemistry System against Syva® EMIT® II Plus Benzodiazepine assay on Syva® 30R Biochemical System. Results demonstrated good agreement between the two immunoassay methods.
Technological Characteristics
Homogeneous enzyme immunoassay; liquid ready-to-use reagents; sheep polyclonal antibodies reactive to diazepam; spectrophotometric detection at 340 nm. Calibrated against lormetazepam. Used on VITROS 5,1 FS Chemistry Systems (automated clinical chemistry analyzer).
Indications for Use
Indicated for professional laboratory use for the qualitative or semi-quantitative determination of benzodiazepines in human urine to aid in the diagnosis and treatment of benzodiazepine use or overdose. Provides preliminary results requiring confirmation by GC/MS.
Regulatory Classification
Identification
A benzodiazepine test system is a device intended to measure any of the benzodiazepine compounds, sedative and hypnotic drugs, in blood, plasma, and urine. The benzodiazepine compounds include chlordiazepoxide, diazepam, oxazepam, chlorzepate, flurazepam, and nitrazepam. Measurements obtained by this device are used in the diagnosis and treatment of benzodiazepine use or overdose and in monitoring levels of benzodiazepines to ensure appropriate therapy.
Special Controls
*Classification.* Class II (special controls). A benzodiazepine test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (*e.g.,* programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).
Predicate Devices
- EMIT II Plus Benzodiazepine Assay (k993985)
- Liquicheck Urine Toxicology Controls (k022707)
Related Devices
- K173963 — DRI Benzodiazepine Assay · Microgenics Corporation · Feb 21, 2018
- K032365 — BENZODIAZEPINE ENZYME IMMUNOASSAY · Lin-Zhi International, Inc. · Sep 5, 2003
Submission Summary (Full Text)
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Image /page/0/Picture/0 description: The image shows the logo for Ortho-Clinical Diagnostics, which is a Johnson & Johnson company. The logo features a stylized caduceus symbol on the left, followed by the text "Ortho-Clinical Diagnostics" in a clean, sans-serif font. Below the company name, the text "a Johnson & Johnson company" is written in a smaller, cursive font.
100 Indigo Creek Drive
Rochester, New York 14626-5101
.
## 5.0 510(k) Summary
## DEC 2 2 2006
| This summary of 510(k) safety and effectiveness information is being<br>submitted in accordance with the requirements of SMDA 1990 and 21<br>CFR 807.92. | | |
|----------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| The assigned 510(k) number is: K062285 | | |
| <b>1. Submitter<br/>name,<br/>address,<br/>contact</b> | Ortho-Clinical Diagnostics, Inc.<br>100 Indigo Creek Drive<br>Rochester, New York 14626-5101<br>(585) 453-4253<br>Contact Person: Darlene Phillips | |
| <b>2. Preparation<br/>Date</b> | August 4, 2006 | |
| <b>3. Device name</b> | <b>Trade or Proprietary Names:</b><br>VITROS Chemistry Products BENZ Reagent<br>VITROS Chemistry Products Calibrator Kit 26<br>VITROS Chemistry Products FS Calibrator 1<br>VITROS Chemistry Products DAT Performance Verifiers<br>I, II, III, IV & V<br><br><b>Common Names:</b><br>Benzodiazepine (BENZ) assay and controls<br><br><b>Classification Names:</b><br>Benzodiazepine test system (862.3170) Class II<br>Clinical toxicology calibrators (862.3200) Class II<br>Clinical toxicology control material (862.3280) Class I, VITROS DAT<br>Performance Verifiers are assayed controls, so they meet the<br>reserved criteria under Section 510(l) of the Food, Drug and<br>Cosmetic Act. | |
| <b>4. Predicate<br/>Devices</b> | The VITROS Chemistry Products BENZ assay is substantially<br>equivalent to the DADE BEHRING Syva® EMIT® II Plus<br>Benzodiazepine Assay.<br><br>The VITROS Chemistry Products DAT Performance Verifiers are<br>substantially equivalent to the BIO-RAD Liquichek™ Urine Toxicology<br>Controls. | |
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The VITROS BENZ assay is a homogeneous enzyme immunoassay 5. Device that is performed using the VITROS Chemistry Products BENZ description Reagent with the VITROS Chemistry Products Calibrator Kit 26, VITROS Chemistry Products FS Calibrator 1, and VITROS Chemistry Products FS Diluent Pack 4 (DAT Diluent / DAT Diluent 2) on VITROS 5,1 FS Chemistry Systems.
> The VITROS BENZ Reagent is a dual chambered package containing ready-to-use liquid reagents that are used to detect benzodiazepines in urine. Sample, calibrators, and controls are automatically treated with surfactant (DAT Diluent 2) prior to addition of reagents. Treated sample is added to Reagent 1 containing antibody reactive to diazepam, glucose-6-phosphate and nicotinamide adenine dinucleotide (NAD), followed by Reagent 2 containing diazepam labeled with the enzyme glucose-6-phosphate dehydrogenase (G6P-DH). The assay is based on competition between benzodiazepines in the treated urine sample and diazepam labeled with the enzyme glucose-6-phosphate dehydrogenase (G6P-DH) for antibody binding sites. Enzyme activity decreases upon binding to the antibody, therefore the concentration of benzodiazepines in the urine sample is directly proportional to measured enzyme activity. Active enzyme converts oxidized nicotinamide adenine dinucleotide (NAD*) to NADH, resulting in an absorbance change that is measured spectrophotometrically at 340 nm.
> VITROS Chemistry Products Calibrator Kit 26 is prepared from human urine to which drugs of abuse, metabolites of drugs of abuse, organic salt, surfactants, and preservative have been added. VITROS FS Calibrator 1 is prepared from sodium chloride and processed water. VITROS Calibrator Kit 26 is used in conjunction with VITROS FS Calibrator 1 to calibrate VITROS 5,1 FS Chemistry Systems for the qualitative or semi-quantitative measurement of benzodiazepine (BENZ).
VITROS Chemistry Products DAT Performance Verifiers I, II, III, IV and V are prepared from a human urine pool to which analytes, surfactant, and preservative have been added. These are assayed controls used to monitor performance of the VITROS BENZ assay on VITROS 5,1 FS Chemistry Systems.
The VITROS Chemistry Products FS Diluent Pack 4 (DAT Diluent/ DAT Diluent 2) is a common reagent that is used with several drugs of abuse assays to dilute calibrators and samples on the VITROS 5,1 FS System. This is a dual chambered package containing two ready-to-use liquid diluents. DAT Diluent is prepared from human urine to which organic salt, surfactants, and preservative have been added. DAT Diluent 2 is prepared from processed water to which surfactant and preservative have been added.
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## 510(k) Summary (continued)
- The VITROS 5.1 FS Chemistry System is a clinical chemistry 5. Device instrument that provides automated use of the VITROS Chemistry description Products MicroTip® and MicroSlides® range of products. The VITROS (continued) 5.1 FS System was cleared for market by 510(k) premarket notification (K031924).
- 6. Device intended uses
VITROS Chemistry Products BENZ Reagent: For in vitro diagnostic use only. VITROS Chemistry Products BENZ Reagent is used on VITROS 5,1 FS Chemistry Systems for the semi-quantitative or qualitative determination of benzodiazepines (BENZ) in human urine using a cutoff of either 200 ng/mL or 300 ng/mL. Measurements obtained with the VITROS BENZ method are used in the diagnosis and treatment of benzodiazepines use or overdose.
The VITROS Chemistry Products BENZ assay is intended for use by professional laboratory personnel. It provides only a preliminary test result. A more specific alternative chemical method must be used to confirm a result obtained with this assay. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drugof-abuse test result, particularly when evaluating a preliminary positive result.
VITROS Chemistry Products Calibrator Kit 26: For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 26 is used to calibrate VITROS 5,1 FS Chemistry Systems for the qualitative or semi-quantitative measurement of drugs of abuse.
VITROS Chemistry Products FS Calibrator 1: For in vitro diagnostic use only. VITROS Chemistry Products FS Calibrator 1 is used in conjunction with VITROS Chemistry Products Calibrator Kits to calibrate VITROS 5,1 FS Chemistry Systems.
VITROS Chemistry Products DAT Performance Verifiers I, III, IV and V: For in vitro diagnostic use only. VITROS Chemistry Products DAT Performance Verifiers are assaved controls used to monitor performance of urine drugs of abuse screening assays on VITROS 5,1 FS Chemistry Systems.
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- The VITROS Chemistry Products BENZ assay and VITROS Chemistry Comparison 7. Products DAT Performance Verifiers are substantially equivalent to the to predicate DADE BEHRING Syva® EMIT® II Plus Benzodiazepine Assay devices (K993985) and BIO-RAD Liquichek™ Urine Toxicology Controls (K022707) (predicate devices) which were cleared by the FDA for in vitro diagnostic use.
The performance of the VITROS BENZ assay on the VITROS 5,1 FS Chemistry System was compared to the Syva® EMIT® II Plus Benzodiazepine assay on the Syva® 30R Biochemical System. The results demonstrated good agreement between the two immunoassay methods.
The VITROS BENZ assay and the VITROS DAT Performance Verifiers have the following similarities to the predicate devices: the same intended use, the same cutoff values of 200 and 300 ng/mL, consist of liquid, ready to use reagents, have similar performance characteristics, are used on an automated clinical chemistry analyzer and calibrated against the same drug, lormetazepam.
- Similarities and differences of the assays performed using the VITROS Table 1 BENZ assay and the VITROS DAT Performance Verifiers and the EMIT® Benzodiazepine assay and BIO-RAD® Liquichek™ Urine Toxicology Controls.
| Device Similarities | |
|--------------------------|----------------------------------------------------------------------------------------------------------------------|
| Device Characteristic | Description |
| Indications for Use | The assays are intended for use in the qualitative and semi-quantitative analysis of benzodiazepines in human urine. |
| Test Principle | Homogeneous enzyme immunoassay |
| Cut-Off values | 200 and 300 ng/mL |
| Sample Type | Human Urine |
| Reagent Format | Liquid ready to use |
| Antibody source | Sheep polyclonal antibodies reactive to diazepam |
| Calibration traceability | Lormetazepam with confirmation by GC/MS |
| Calibrator matrix | Human urine |
| Control matrix | Human urine |
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| Differences | | |
|---------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device<br>Characteristic | VITROS BENZ assay<br>(New device) | EMIT® Benzodiazepines assay<br>and LiquichekTM Urine<br>Toxicology Controls<br>(Predicate devices) |
| Reportable Range | 85 - 800 ng/mL | 40 - 900 ng/mL |
| Calibrator: Number of<br>levels | Six | Qualitative: Three at each cutoff<br>value<br>Semi-quantitative: Five |
| Calibrator format | Frozen Liquid ready to use | Refrigerated liquid ready to use |
| Instrumentation | To be used on VITROS 5,1 FS<br>Chemistry Systems | Multiple automated clinical<br>chemistry systems |
| Control claimed<br>analytes | Cocaine metabolites<br>(benzoylecgonine),<br>benzodiazepines<br>(lormetazepam), methadone,<br>amphetamines (d-<br>methamphetamine), opiates<br>(morphine), cannabinoids (11-<br>nor-delta-THC-9-COOH),<br>phencyclidine and barbiturates<br>(secobarbital). | Methamphetamine, secobarbital,<br>lormetazepam,<br>tetrahydrocannabinol (THC),<br>benzoylecgonine, ethanol,<br>lysergic acid diethylamide (LSD),<br>methadone, methaqualone,<br>morphine, (Free), phencyclidine,<br>propoxyphene, nortriptyline and<br>addition of creatinine, pH,<br>specific gravity. |
| Control: Number of<br>levels | Five | Two |
- 8. Conclusions The data presented in the premarket notification provide a reasonable assurance that the VITROS Chemistry Products BENZ Reagent, VITROS Chemistry Products Calibrator Kit 26, VITROS Chemistry Products FS Calibrator 1 and VITROS Chemistry Products DAT Performance Verifiers are safe and effective for the stated intended uses and are substantially equivalent to the cleared predicate devices. Equivalence to the predicates was demonstrated using a commercially available assay along with patient samples.
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Image /page/5/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Darlene J. Phillips, RAC Regulatory Associate Ortho-Clinical Diagnostics 100 Indigo Creek Drive Rochester, NY 14626-5101
DEC 2 2 2006
Re: k062285
Trade Name: Vitros Chemistry Products BENZ Reagent, Calibrator Kit 26, DAT Performance Verifiers I. II. III. IV & V Regulation Number: 21 CFR 862.3170 Benzodiazepine Test System Regulation Name: JXM, DKB, DIF Product Code: Dated: December 14, 2006 Received: December 15, 2006
Dear Ms. Phillips:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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Page 2 -
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0490. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Jean M. Cooper, M.S., D.V.M.
Yean M. Cooper, M.S., D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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## Indications for Use
510(k) Number (if known):
K
$$\alpha$$
6228\$
Page 1 of 2
Device Name: VITROS Chemistry Products BENZ Reagent
Indications for Use:
VITROS Chemistry Products BENZ Reagent is used on VITROS 5.1 FS Chemistry Systems for the semi-quantitative or qualitative determination of benzodiazepines (BENZ) in human urine using a cutoff of either 200 ng/mL or 300 ng/mL. Measurements obtained with the VITROS BENZ method are used in the diagnosis and treatment of benzodiazepines use or overdose.
The VITROS Chemistry Products BENZ assay is intended for use by professional laboratory personnel. It provides only a preliminary test result. A more specific alternative chemical method must be used to confirm a result obtained with this assay. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drugof-abuse test result, particularly when evaluating a preliminary positive result.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Vasion-Off
of In Vitro Diagnostic Device tion and Safet
062285
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Indications for Use
510(k) Number (if known):
K06228\$\\$
Page 2 of 2
Device Name: VITROS Chemistry Products Calibrator Kit 26 VITROS Chemistry Products FS Calibrator 1 VITROS Chemistry Products DAT Performance Verifiers I, II, III, IV and V
Indications For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit for Use: 26 is used to calibrate VITROS 5,1 FS Chemistry Systems for the qualitative or semi-quantitative measurement of drugs of abuse.
> For in vitro diagnostic use only. VITROS Chemistry Products FS Calibrator 1 is used in conjunction with VITROS Chemistry Products Calibrator Kits to calibrate VITROS 5,1 FS Chemistry Systems.
For in vitro diagnostic use only. VITROS Chemistry Products DAT Performance Verifiers are assayed controls used to monitor performance of urine drugs of abuse screening assays on VITROS 5,1 FS Chemistry Systems.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) Over-The-Counter Use
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
