(78 days)
VITROS Chemistry Products METD Reagent is used on VITROS 5,1 FS Chemistry Systems for the semi-quantitative or qualitative determination of methadone (METD) in human urine using a cutoff of either 150 ng/mL or 300 ng/mL. Measurements obtained with the VITROS METD method are used in the diagnosis and treatment of methadone use or overdose.
The VITROS Chemistry Products METD 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 drug-of-abuse test result, particularly when evaluating a preliminary positive result.
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.
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.
The VITROS METD assay is a homogeneous enzyme immunoassay that is performed using the VITROS Chemistry Products METD Reagent in conjunction with the VITROS Chemistry Products Calibrator Kit 26 and VITROS Chemistry Products FS Diluent Pack 4 (DAT Diluent/DAT Diluent 2) on VITROS 5,1 FS Chemistry Systems.
The VITROS METD Reagent is a dual chambered package containing ready-to-use liquid reagents that are used to detect methadone 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 antibodies reactive to methadone, glucose-6-phosphate and nicotinamide adenine dinucleotide (NAD*), followed by Reagent 2 containing methadone labeled with the enzyme glucose-6-phosphate dehydrogenase (G6P-DH). The assay is based on competition between methadone in the treated urine sample and the methadone 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 methadone 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 Calibrator Kit 26 is a single fluid and from it six dilutions are performed by the VITROS 5,1 FS Chemistry System to create a total of six calibrators. These standards are used to calibrate VITROS 5,1 FS Chemistry Systems for the qualitative or semi-quantitative measurement of methadone (METD).
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 METD 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.
The VITROS 5,1 FS Chemistry System is a clinical chemistry instrument that provides automated use of the VITROS Chemistry Products MicroTip® and MicroSlides® range of products. The VITROS 5,1 FS System was cleared for market by 510(k) premarket notification (K031924).
Here's a breakdown of the acceptance criteria and study information for the VITROS Chemistry Products METD Reagent, VITROS Chemistry Products Calibrator Kit 26, and VITROS Chemistry Products DAT Performance Verifiers, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a quantitative manner as one might find for a pass/fail threshold. Instead, it describes the results in terms of "good agreement" with the predicate device. The primary performance metric mentioned is agreement between the new device and the predicate device for methadone detection in urine.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Good agreement with predicate device (EMIT® II Plus Methadone Assay) for methadone detection in human urine. | "The results demonstrated good agreement between the two immunoassay methods." |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document states that "patient samples" were used. However, it does not specify the number of patient samples in the test set.
- Data Provenance: The document does not explicitly state the country of origin or whether the study was retrospective or prospective. It uses the general term "patient samples," which typically implies prospective collection for such validation studies, but this is not explicitly confirmed.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. For an in vitro diagnostic device for drug testing, "ground truth" is typically established by a more specific and accurate analytical method rather than human expert consensus.
4. Adjudication Method for the Test Set
This information is not applicable or provided for this type of in vitro diagnostic device study. Adjudication methods (like 2+1 or 3+1) are typically used in imaging or clinical evaluation studies where human readers are involved in interpreting results. For chemical assays, the comparison is typically against a reference method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Human Improvement with AI vs. Without AI Assistance
- Was an MRMC study done? No.
- Effect size of human improvement with AI vs. without AI assistance: This information is not applicable as the device is an in vitro diagnostic assay, not an AI-assisted diagnostic tool for human readers.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Was a standalone study done? Yes. The study directly compares the performance of the VITROS METD assay (an automated chemical assay) against a predicate device on an automated analyzer. This is inherently a standalone performance evaluation of the assay itself.
7. The Type of Ground Truth Used
The ground truth for the test set was established by comparison to a predicate device, specifically the EMIT® II Plus Methadone Assay on the OLYMPUS® AU400 System. While not explicitly stated as "ground truth" in the document, in the context of substantial equivalence, the predicate device's established performance serves as the reference for the new device. For confirming positive results in drug-of-abuse testing, the document explicitly states that Gas Chromatography/Mass Spectrometry (GC/MS) is the preferred confirmatory method, implying that GC/MS would be the ultimate ground truth. However, the equivalence study itself was against another immunoassay.
8. The Sample Size for the Training Set
The document does not specify a separate "training set" or its size. For a chemical assay like this, the assay development and optimization phases would involve numerous samples, but these are generally not referred to as a "training set" in the same way as machine learning models. The calibration and control materials are described, but not a dataset used to "train" the underlying assay principle.
9. How the Ground Truth for the Training Set Was Established
Since a "training set" is not explicitly defined in the context of this document, the method for establishing its ground truth is not provided. The calibrators and controls used for the assay are prepared with known concentrations of methadone, establishing their "ground truth" by design.
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Image /page/0/Picture/0 description: The image shows the logo for Ortho-Clinical Diagnostics. The logo consists of a symbol on the left, followed by the text "Ortho-Clinical Diagnostics" in a stylized font. A thin line runs beneath the text. The symbol on the left appears to be a stylized medical symbol.
Johnson-Johnson company
100 Indigo Creek Drive NO & 2 2Agghester, New York 14626-5101
5.0 510(k) Summary
165
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92. 062637
The assigned 510(k) number is:
Ortho-Clinical Diagnostics, Inc.
Rochester, New York 14626-5101
-
- Submitter name, address, contact
(585) 453-4253 Contact Person: Darlene Phillips
- Submitter name, address, contact
100 Indigo Creek Drive
- September 1, 2006 2. Preparation Date
Trade or Proprietary Names: 3. Device name
VITROS Chemistry Products METD Reagent VITROS Chemistry Products Calibrator Kit 26 VITROS Chemistry Products DAT Performance Verifiers I, II, III, IV & V
Common Names:
Methadone (METD) assay and controls
Classification Names:
Methadone test system (862.3620) Class II Clinical toxicology calibrators (862.3200) Class II Clinical toxicology control material (862.3280) Class I, VITROS DAT Performance Verifiers are assayed controls, so they meet the reserved criteria under Section 510(1) of the Food, Drug and Cosmetic Act.
The VITROS Chemistry Products METD assay is substantially 4. Predicate equivalent to the EMIT® II Plus Methadone Assay. Devices The VITROS Chemistry Products DAT Performance Verifiers are substantially equivalent to the BIO-RAD Liquichek™ Urine Toxicology Controls.
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- The VITROS METD assay is a homogeneous enzyme immunoassay that 5. Device description is performed using the VITROS Chemistry Products METD Reagent in conjunction with the VITROS Chemistry Products Calibrator Kit 26 and VITROS Chemistry Products FS Diluent Pack 4 (DAT Diluent/DAT Diluent 2) on VITROS 5,1 FS Chemistry Systems.
The VITROS METD Reagent is a dual chambered package containing ready-to-use liquid reagents that are used to detect methadone 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 antibodies reactive to methadone, glucose-6-phosphate and nicotinamide adenine dinucleotide (NAD*), followed by Reagent 2 containing methadone labeled with the enzyme glucose-6-phosphate dehydrogenase (G6P-DH). The assay is based on competition between methadone in the treated urine sample and the methadone 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 methadone 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 Calibrator Kit 26 is a single fluid and from it six dilutions are performed by the VITROS 5,1 FS Chemistry System to create a total of six calibrators. These standards are used to calibrate VITROS 5,1 FS Chemistry Systems for the qualitative or semi-quantitative measurement of methadone (METD).
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 METD 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.
Continued on next page
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Kc62631
3075
| 5. Devicedescription(continued) | The VITROS 5,1 FS Chemistry System is a clinical chemistryinstrument that provides automated use of the VITROS ChemistryProducts MicroTip® and MicroSlides® range of products. The VITROS5,1 FS System was cleared for market by 510(k) premarket notification(K031924). |
|---|---|
| 6. Deviceintended uses | VITROS Chemistry Products METD Reagent: For in vitro diagnosticuse only. VITROS Chemistry Products METD Reagent is used onVITROS 5,1 FS Chemistry Systems for the semi-quantitative orqualitative determination of methadone (METD) in human urine using acutoff of either 150 ng/mL or 300 ng/mL. Measurements obtained withthe VITROS METD method are used in the diagnosis and treatment ofmethadone use or overdose. |
| Device | The VITROS Chemistry Products METD assay is intended for use byprofessional laboratory personnel. It provides only a preliminary testresult. A more specific alternative chemical method must be used toconfirm a result obtained with this assay. Gas chromatography/massspectrometry (GC/MS) is the preferred confirmatory method. Clinicalconsideration and professional judgment should be applied to any drug-of-abuse test result, particularly when evaluating a preliminary positiveresult. |
| Device | VITROS Chemistry Products Calibrator Kit 26: For in vitrodiagnostic use only. VITROS Chemistry Products Calibrator Kit 26 isused to calibrate VITROS 5,1 FS Chemistry Systems for the qualitativeor semi-quantitative measurement of drugs of abuse. |
| Device | VITROS Chemistry Products DAT Performance Verifiers I, II, III,IV and V: For in vitro diagnostic use only. VITROS ChemistryProducts DAT Performance Verifiers are assayed controls used tomonitor performance of urine drugs of abuse screening assays onVITROS 5,1 FS Chemistry Systems. |
| 7. Comparisonto predicatedevices | The VITROS Chemistry Products METD assay and VITROS ChemistryProducts DAT Performance Verifiers are substantially equivalent to theEMIT® II Plus Methadone Assay (K010962) and BIO-RAD Liquichek™Urine Toxicology Controls (K022707) (predicate devices) which werecleared by the FDA for in vitro diagnostic use. |
| The performance of the VITROS METD assay on the VITROS 5,1 FSChemistry System was compared to the EMIT® II Plus Methadone assayon the OLYMPUS® AU400 System. The results demonstrated goodagreement between the two immunoassay methods. |
Continued on next page
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The VITROS METD assay and the VITROS DAT Performance Verifiers have the following similarities to the predicate devices: the same intended use, the same cutoff values of 150 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, methadone.
| Table 1 Similarities and differences of the assays performed using the new and |
|---|
| predicate devices |
| Device Similarities | |
|---|---|
| Device Characteristic | Description |
| Indications for Use | The assays are intended for use in the qualitative and semi-quantitative analysis of methadone in human urine. |
| Test Principle | Homogeneous enzyme immunoassay |
| Cut-Off values | 150 and 300 ng/mL |
| Sample Type | Human Urine |
| Reagent Format | Liquid ready to use |
| Antibody source | Sheep polyclonal antibodies reactive to methadone |
| Calibration traceability | Methadone |
| Calibrator matrix | Human urine |
| Control matrix | Human urine |
| Differences | ||
|---|---|---|
| DeviceCharacteristic | VITROS METD assay(New device) | EMIT® Methadone assay andLiquichek™ Controls(Predicate devices) |
| Number of Calibratorlevels | Six | Four |
| Calibrator format | Frozen Liquid ready to use | Refrigerated liquid ready to use |
| Instrumentation | VITROS 5,1 FS ChemistrySystems | Multiple OLYMPUS analyzers |
| Control claimedanalytes | Cocaine metabolites(benzoylecgonine),benzodiazepines(lormetazepam), methadone,amphetamines (d-methamphetamine), opiates(morphine), cannabinoids (11-nor-delta-THC-9-COOH),phencyclidine and barbiturates(secobarbital) | Methamphetamine, secobarbital,lormetazepam,tetrahydrocannabinol (THC),benzoylecgonine, ethanol,lysergic acid diethylamide (LSD),methadone, methaqualone,morphine, (Free), phencyclidine,propoxyphene, nortriptyline andaddition of creatinine, pH,specific gravity. |
| Control: Number oflevels | Five | Two |
Table 1 Similarities and differences of the assays performed using the predicate devices..
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510(k) Summary (continued)
-
- Conclusions The data presented in the premarket notification provide a reasonable assurance that the VITROS Chemistry Products METD Reagent, VITROS Chemistry Products Calibrator Kit 26 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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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/5/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, in the center. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The seal is black and white.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Darlene J. Phillips Regulatory Associate 100 Indigo Creek Drive Rochester, New York 14626-5101
NOV 2 2 2006
Re: K062637
Trade/Device Name: VITROS Chemistry Products METD Reagent Regulation Number: 21 CFR 862.3620 Regulation Name: Methadone test system Regulatory Class: Class II Product Code: DJR, DKB, DIF Dated: September 1, 2006 Received: September 5, 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) 276-0484. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Alberto Gutiér
Alberto Gutierrez, Ph.D. 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):
6621637
Device Name: VITROS Chemistry Products METD Reagent
Indications VITROS Chemistry Products METD Reagent is used on VITROS for Use: 5,1 FS Chemistry Systems for the semi-quantitative or qualitative determination of methadone (METD) in human urine using a cutoff of either 150 ng/mL or 300 ng/mL. Measurements obtained with the VITROS METD method are used in the diagnosis and treatment of methadone use or overdose.
The VITROS Chemistry Products METD 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 _________________________________________________________________________________________________________________________________________________________ AND/OR -(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Cfe
AVIsion Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
Page 1 of 2
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Indications for Use
510(k) Number (if known):
062637
S. S. Kresge Foundation
Device Name: VITROS Chemistry Products Calibrator Kit 26 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 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 _X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
062637
Page 2 of 2
§ 862.3620 Methadone test system.
(a)
Identification. A methadone test system is a device intended to measure methadone, an addictive narcotic pain-relieving drug, in serum and urine. Measurements obtained by this device are used in the diagnosis and treatment of methadone use or overdose and to determine compliance with regulations in methadone maintenance treatment.(b)
Classification. Class II (special controls). A methadone 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).