(78 days)
Not Found
No
The description details a standard enzyme immunoassay and the associated reagents and instrument. There is no mention of AI or ML in the intended use, device description, or performance studies.
No.
Explanation: The device is an in vitro diagnostic product used for the semi-quantitative or qualitative determination of methadone in human urine to diagnose and treat methadone use or overdose. It does not directly treat a patient; it provides information for diagnosis and treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states, "Measurements obtained with the VITROS METD method are used in the diagnosis and treatment of methadone use or overdose." Additionally, it is stated as "For in vitro diagnostic use only."
No
The device description clearly outlines physical reagents (VITROS Chemistry Products METD Reagent, Calibrator Kit 26, FS Diluent Pack 4, DAT Performance Verifiers) and relies on a specific hardware system (VITROS 5,1 FS Chemistry System) to perform the assay. This is not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The document explicitly states "For in vitro diagnostic use only" multiple times.
- Intended Use: The intended use is for the "semi-quantitative or qualitative determination of methadone (METD) in human urine." This is a test performed on a biological sample (urine) outside of the body (in vitro) to provide information for diagnosis and treatment.
- Diagnosis and Treatment: The results are used "in the diagnosis and treatment of methadone use or overdose." This directly aligns with the purpose of IVDs.
- Professional Laboratory Personnel: The intended user is "professional laboratory personnel," indicating use in a clinical laboratory setting, which is typical for IVDs.
- Device Description: The description details a reagent kit, calibrators, and controls used with a chemistry system to perform a test on urine samples. These are all components of an IVD system.
N/A
Intended Use / Indications for Use
The 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.
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 DAT Performance Verifiers I, II, III, IV and V: 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.
Product codes
DJR, DKB, DIF
Device Description
The VITROS Chemistry Products 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human urine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
professional laboratory personnel
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The performance of the VITROS METD assay on the VITROS 5,1 FS Chemistry System was compared to the EMIT® II Plus Methadone assay on the OLYMPUS® AU400 System. The results demonstrated good agreement between the two immunoassay methods.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
EMIT® II Plus Methadone Assay (K010962), BIO-RAD Liquichek™ Urine Toxicology Controls (K022707)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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.
Continued on next page
1
- 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
2
Kc62631
3075
| 5. Device
description
(continued) | 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). |
|------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 6. Device
intended uses | VITROS Chemistry Products METD Reagent: For in vitro diagnostic
use only. 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. |
| Device | 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. |
| Device | 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. |
| Device | VITROS Chemistry Products DAT Performance Verifiers I, II, III,
IV and V: 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. |
| 7. Comparison
to predicate
devices | The VITROS Chemistry Products METD assay and VITROS Chemistry
Products DAT Performance Verifiers are substantially equivalent to the
EMIT® II Plus Methadone Assay (K010962) 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 METD assay on the VITROS 5,1 FS
Chemistry System was compared to the EMIT® II Plus Methadone assay
on the OLYMPUS® AU400 System. The results demonstrated good
agreement between the two immunoassay methods. |
Continued on next page
3
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 | ||
|---|---|---|
| Device | ||
| Characteristic | VITROS METD assay | |
| (New device) | EMIT® Methadone assay and | |
| Liquichek™ Controls | ||
| (Predicate devices) | ||
| Number of Calibrator | ||
| levels | Six | Four |
| Calibrator format | Frozen Liquid ready to use | Refrigerated liquid ready to use |
| Instrumentation | VITROS 5,1 FS Chemistry | |
| Systems | Multiple OLYMPUS analyzers | |
| Control claimed | ||
| analytes | 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 and | ||
| addition of creatinine, pH, | ||
| specific gravity. | ||
| Control: Number of | ||
| levels | Five | Two |
Table 1 Similarities and differences of the assays performed using the predicate devices..
4
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.
5
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).
6
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
7
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
8
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