(114 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 described as "For in vitro diagnostic use only" and is explicitly used for "the semiquantitative or qualitative determination of opiates (OP) in human urine." This indicates it is an in vitro diagnostic (IVD) device used for testing purposes, not a therapeutic device meant to treat or cure a disease. While the measurements can be "used in the diagnosis and treatment of opiate use or overdose," the device itself is a diagnostic tool, not a therapeutic one.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states, "Measurements obtained with the VITROS OP method are used in the diagnosis and treatment of opiate use or overdose." This indicates that the device provides information for diagnostic purposes.
No
The device description clearly outlines physical reagents (VITROS Chemistry Products OP Reagent, Calibrator Kit 26, DAT Performance Verifiers, FS Diluent Pack 4) and relies on a physical instrument (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 "Intended Use / Indications for Use" section explicitly states "For in vitro diagnostic use only." This is the most direct indicator.
- Purpose: The device is used to determine the presence of opiates in human urine, which is a biological sample. This analysis is performed outside of the body ("in vitro").
- Clinical Use: The results are used in the "diagnosis and treatment of opiate use or overdose," which is a clear clinical application.
- Components: The description details reagents, calibrators, and controls specifically designed for laboratory testing of biological samples.
- Intended User: The device is intended for "professional laboratory personnel," indicating use in a clinical laboratory setting.
N/A
Intended Use / Indications for Use
For in vitro diagnostic use only. VITROS Chemistry Products OP Reagent is used on VITROS 5,1 FS Chemistry Systems for the semiquantitative or qualitative determination of opiates (OP) in human urine using a cutoff of either 300 ng/mL or 2000 ng/mL. Measurements obtained with the VITROS OP method are used in the diagnosis and treatment of opiate use or overdose.
The VITROS Chemistry Products OP 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.
Product codes
DJG, DKB, DIF
Device Description
The VITROS OP assay is a homogeneous enzyme immunoassay that is performed using the VITROS Chemistry Products OP Reagent 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. Two protocols using the VITROS OP assay are available to support the two cutoff values. The OP-LO protocol is used to support the 300 ng/mL cutoff value. The OP-HI protocol is used to support the 2000 ng/mL cutoff value.
The VITROS OP Reagent is a dual chambered package containing ready-to-use liquid reagents that are used to detect opiates 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 morphine, glucose-6-phosphate and nicotinamide adenine dinucleotide (NAD'), followed by Reagent 2 containing morphine labeled with the enzyme glucose-6-phosphate dehydrogenase (G6P-DH). The assay is based on competition between opiates in the treated urine sample and the morphine 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 opiates 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.
The 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 on 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 and semi-quantitative measurement of Opiates (OP).
The VITROS Chemistry Products DAT Performance Verifiers I, II, III, IV, and V are quality control materials 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 OP 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 by multiple assays on the VITROS 5,1 FS Chemistry 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 marker by 510(k) premarket notification (K031924).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
The performance of the VITROS OP assay on the VITROS 5,1 FS Chemistry System was compared to the EMIT® II Plus Opiate assay on the Olympus AU400 Analyzer. The results demonstrated good agreement between the two immunoassay methods.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.3650 Opiate test system.
(a)
Identification. An opiate test system is a device intended to measure any of the addictive narcotic pain-relieving opiate drugs in blood, serum, urine, gastric contents, and saliva. An opiate is any natural or synthetic drug that has morphine-like pharmocological actions. The opiates include drugs such as morphine, morphine glucoronide, heroin, codeine, nalorphine, and meperedine. Measurements obtained by this device are used in the diagnosis and treatment of opiate use or overdose and in monitoring the levels of opiate administration to ensure appropriate therapy.(b)
Classification. Class II (special controls). An opiate 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
Ortho-Clinical Diagnostics
Johnson-Johnson company
DEC 1 ▷ 2006
100 Indigo Creek Drive Rochester, New York 14626-5101
5.0 510(k) Summary
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.
The assigned 510(k) number is: Ko2460
- Ortho-Clinical Diagnostics, Inc. 1. Submitter 100 Indigo Creek Drive name, address, Rochester, New York 14626-5101 (585) 453-4041 contact Contact Person: Marlene Hanna
- August 22, 2006 2. Preparation Date
- Device name Trade or Proprietary Names: VITROS Chemistry Products OP Reagent VITROS Chemistry Products Calibrator Kit 26 VITROS Chemistry Products DAT Performance Verifiers I, II, III, IV, and V
Common Names:
Opiates assay and controls
Classification Names:
l . Opiate test system (21 CFR 862.3650) Class II 2. Clinical toxicology calibrators (21 CFR 862.3200) Class II 3. Clinical toxicology control material (21 CFR 862.3280) DAT Performance Verifiers I, II ,III, IV, and V) are assayed controls, so they meet the reserved criteria under Section 510(1) of the Food, Drug, and Cosmetic Act.
Continued on next page
1
-
- Predicate The VITROS Chemistry Products OP assay is substantially equivalent to the EMIT® II Devices Plus Opiate assay.
The VITROS Chemistry Products DAT Performance Verifiers are substantially equivalent to the Bio-Rad Liquicheck™ UrineToxicology Controls.
- Predicate The VITROS Chemistry Products OP assay is substantially equivalent to the EMIT® II Devices Plus Opiate assay.
-
The VITROS OP assay is a homogeneous enzyme immunoassay that is performed 5. Device using the VITROS Chemistry Products OP Reagent with the VITROS Chemistry description Products Calibrator Kit 26 and VITROS Chemistry Products FS Diluent Pack 4 (DAT Diluent / DAT Diluent 2) on VITROS 5,1 FS Chemistry Systems. Two protocols using the VITROS OP assay are available to support the two cutoff values. The OP-LO protocol is used to support the 300 ng/mL cutoff value. The OP-HI protocol is used to support the 2000 ng/mL cutoff value.
The VITROS OP Reagent is a dual chambered package containing ready-to-use liquid reagents that are used to detect opiates 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 morphine, glucose-6-phosphate and nicotinamide adenine dinucleotide (NAD'), followed by Reagent 2 containing morphine labeled with the enzyme glucose-6phosphate dehydrogenase (G6P-DH). The assay is based on competition between opiates in the treated urine sample and the morphine 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 opiates 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.
The 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 on 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 and semi-quantitative measurement of Opiates (OP).
The VITROS Chemistry Products DAT Performance Verifiers I, II, III, IV, and V are quality control materials 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 OP assay on VITROS 5,1 FS Chemistry Systems.
Continued on next page
2
| 6. Device
intended uses | The VITROS Chemistry Products FS Diluent Pack 4 (DAT Diluent / DAT Diluent 2 is a common reagent that is used by multiple assays on the VITROS 5,1 FS Chemistry 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 marker by 510(k) premarket notification (K031924).
VITROS Chemistry Products OP Reagent: For in vitro diagnostic use only. VITROS Chemistry Products OP Reagent is used on VITROS 5,1 FS Chemistry Systems for the semi-quantitative or qualitative determination of opiates (OP) in human urine using a cutoff of either 300 ng/mL or 2000 ng/mL. Measurements obtained with the VITROS OP method are used in the diagnosis and treatment of opiate use or overdose.
The VITROS Chemistry Products OP 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. |
|-------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 7. Comparison to
predicate
devices: | The VITROS Chemistry Products OP assay and VITROS Chemistry Products DAT Performance Verifiers are substantially equivalent to the EMIT® II Plus Opiate assay (K011289) and Bio-Rad Liquicheck™ Urine Toxicology Controls (K022707) predicate devices which were cleared by the FDA for IVD use. |
Continued on next page
3
The performance of the VITROS OP assay on the VITROS 5,1 FS Chemistry System was compared to the EMIT® II Plus Opiate assay on the Olympus AU400 Analyzer. The results demonstrated good agreement between the two immunoassay methods.
The VITROS OP assay and VITROS DAT Performance Verifiers have the following similarities to the predicate devices: same intended use, the same cutoff values of 300 or 2000 ng/mL, are liquid, ready to use reagents, have similar performance characteristics, are used on an automated clinical chemistry analyzer and calibrated against the same drug, morphine.
| Table 1 | Similarities and differences of the assays performed using the VITROS OP assay and DAT |
|---|---|
| controls and the EMIT® II Plus Opiate assay and Bio-Rad Urine Toxicology controls. |
| Device Similarities | ||
|---|---|---|
| Device Characteristic | Description | |
| Indications for Use | For in vitro diagnostic use only. The assays are intended for use in the qualitative | |
| and semi-quantitative analysis of opiates in human urine. The controls are | ||
| assayed controls used to monitor the performance of Chemistry Systems. | ||
| Test Principle | Homogeneous enzyme immunoassay | |
| Cut-Off values | 300 or 2000 ng/mL | |
| Specimen Type | Human Urine | |
| Reagent Format | Liquid ready to use | |
| Antibody source | Sheep polyclonal antibodies reactive to morphine | |
| Calibration traceability | Traceable to morphine with confirmation by GC/MS. | |
| Calibrator matrix | Human urine | |
| Control matrix | Human urine | |
| Device Differences | ||
| Device Characteristic | VITROS OP assay | |
| (New device) | Emit® II Plus Opiates assay | |
| (Predicate device) | ||
| Calibrator levels | 6 levels | Qualitative: Two levels |
| Semi-quantitative: Four levels | ||
| Calibrator format | Frozen Liquid ready to use | Refrigerated liquid ready to use |
| Instrumentation | To be used on VITROS 5,1 FS | |
| Chemistry Systems | For use on a variety of OLYMPUS® | |
| analyzers | ||
| Controls: Drugs | ||
| Reported | Cocaine metabolites | |
| (benzoylecgonine), | ||
| benzodiazepines (lormetazepam), | ||
| methadone, Barbiturates | ||
| (secobarbital), 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. | ||
| Controls: Number of | Five | Two |
4
510(k) Summary (continued)
- Conclusions The data presented in the premarket notification provide a reasonable assurance that the VITROS Chemistry Products OP Reagent, VITROS Chemistry Products Calibrator Kit 26, and the 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
Image /page/5/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized eagle with three stripes forming its body and wing. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Marlene Hanna Ortho-Clinical Diagnostics, Inc. 100 Indigo Creek Drive Rochester, New York 14626-5101
DEC 1 5 2006
Re: K062460
Trade/Device Name: VITROS Chemistry Products OP Reagent Regulation Number: 21 CFR 862.3650 Regulation Name: Opiate test system Regulatory Class: Class II Product Code: DJG, DKB, DIF Dated: October 4, 2006 Received: October 5, 2006
Dear Ms. Hanna:
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 yours,
Albert Guttman, Ph.D.
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):
K 062460
known):
Device Name: VITROS Chemistry Products OP Reagent
Indications for Use:
For in vitro diagnostic use only. VITROS Chemistry Products OP Reagent is used on VITROS 5,1 FS Chemistry Systems for the semiquantitative or qualitative determination of opiates (OP) in human urine using a cutoff of either 300 ng/mL or 2000 ng/mL. Measurements obtained with the VITROS OP method are used in the diagnosis and treatment of opiate use or overdose.
The VITROS Chemistry Products OP 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.
Prescription Use (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)
Signature
Jivision Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
Ola2460
Page 1 of 2
8
Indications for Use
Page 2 of 2
| 510(k) Number (if known): | K062460 |
|---|---|
| Device Name: | VITROS Chemistry Products Calibrator Kit 26 |
| VITROS Chemistry Products DAT Performance Verifiers I, II, III, IV, and V. | |
| Indications for Use: | 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. |
Prescription Use __X (Part 21 CFR 801 Subpart D) AND/OR
(21 CFR 807 Subpart C)
Over-The-Counter Use _
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
C
vision Sign-Off
Office of In Vitro Diagnostic Device Us Anation and Safety
062460