(161 days)
No
The description details a standard enzyme immunoassay and associated reagents and calibrators for a chemistry analyzer. There is no mention of AI or ML in the intended use, device description, or performance studies.
No.
The device is used for in vitro diagnostic testing to detect barbiturates in human urine, which provides diagnostic information but does not treat a condition.
Yes
The "Intended Use / Indications for Use" section explicitly states, "For in vitro diagnostic use only." and "Measurements obtained with the VITROS BARB method are used in the diagnosis and treatment of barbiturates use or overdose."
No
The device description clearly outlines physical reagents (VITROS Chemistry Products BARB Reagent, Calibrator Kit 26, FS Calibrator 1, 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.
Based on the provided text, the 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 phrase is a clear indicator that the device is intended for use outside of a living organism to diagnose or detect conditions.
- Nature of the Test: The device is used for the "semi-quantitative or qualitative determination of barbiturates (BARB) in human urine." Testing bodily fluids like urine to detect substances is a hallmark of in vitro diagnostics.
- Purpose of the Measurement: The measurements are used "in the diagnosis and treatment of barbiturates use or overdose." This directly relates the test results to clinical decision-making, which is a key function of IVDs.
- Components: The description details reagents, calibrators, and controls, which are typical components of IVD test kits.
- Intended User: The assay is intended for "professional laboratory personnel," indicating use in a controlled laboratory setting, common for IVDs.
- Predicate Devices: The listed predicate devices (Syva® EMIT II Plus Barbiturate assay and Bio-Rad Liquicheck™ Urine Toxicology Controls) are also IVD products, further supporting the classification of this device as an IVD.
N/A
Intended Use / Indications for Use
VITROS Chemistry Products BARB Reagent: For in vitro diagnostic use only. VITROS Chemistry Products BARB Reagent is used on VITROS 5,1 FS Chemistry Systems for the semi-quantitative or qualitative determination of barbiturates (BARB) in human urine using a cutoff of either 200 ng/mL or 300 ng/mL. Measurements obtained with the VITROS BARB method are used in the diagnosis and treatment of barbiturates use or overdose. The VITROS Chemistry Products BARB 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 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, 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 (comma separated list FDA assigned to the subject device)
DIS, DKB, DIF
Device Description
The VITROS BARB assay is a homogeneous enzyme immunoassay that is performed using the VITROS Chemistry Products BARB 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 BARB Reagent is a dual chambered package containing ready-to-use liquid reagents that are used to detect barbiturates 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 secobarbital, glucose-6-phosphate and nicotinamide adenine dinucleotide (NAD*), followed by Reagent 2 containing secobarbital labeled with the enzyme glucose-6phosphate dehydrogenase (G6P-DH). The assay is based on competition between barbiturates in the treated urine sample and secobarbital 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 barbiturates 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 Chemistry Products FS Calibrator 1 is prepared from sodium chloride and processed water. These standards are used to calibrate VITROS 5,1 FS Chemistry Systems for the qualitative and semiquantitative measurement of barbiturates (BARB).
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 BARB 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.
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 BARB assay on the VITROS 5,1 FS Chemistry System was compared to the Syva® EMIT II Plus Barbiturate assay on the SYVA 30R System. The results demonstrated good agreement between the two immunoassay methods.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 862.3150 Barbiturate test system.
(a)
Identification. A barbiturate test system is a device intended to measure barbiturates, a class of hypnotic and sedative drugs, in serum, urine, and gastric contents. Measurements obtained by this device are used in the diagnosis and treatment of barbiturate use or overdose and in monitoring levels of barbiturate to ensure appropriate therapy.(b)
Classification. Class II (special controls). A barbiturate 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, which is a Johnson & Johnson company. The logo features a stylized symbol on the left, followed by the company name in a clean, sans-serif font. Below the company name, the text "a Johnson-Johnson company" is written in a smaller, cursive font.
JAN - 5 2007
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: كت كت
Ortho-Clinical Diagnostics, Inc. 1. Submitter name, 100 Indigo Creek Drive address, Rochester, New York 14626-5101 contact (585) 453-4041 Contact Person: Marlene Hanna
-
- Preparation July 27, 2006 Date
3. Device name Trade or Proprietary Names:
VITROS Chemistry Products BARB Reagent VITROS Chemistry Products Calibrator Kit 26 VITROS Chemistry Products FS Calibrator 1 VITROS Chemistry Products DAT Performance Verifiers I, II, III, IV, and V
Common Names: Barbiturates assay and controls
Classification Names:
-
Barbiturates test system (21 CFR 862.3150) Class II
-
Clinical toxicology calibrators (21 CFR 862.3200) Class II
-
Clinical toxicology control material (21 CFR 862.3280) DAT Performance Verifiers I, II ,III, IV, andV) are assayed controls, so they meet the reserved criteria under Section 510(l) of the Food, Drug, and Cosmetic Act.
Continued on next page
1
-
- Predicate The VITROS Chemistry Products BARB assay is substantially equivalent to the Devices Syva® EMIT II Plus Barbiturate assay. The VITROS Chemistry Products DAT Performance Verifiers are substantially equivalent to the Bio-Rad Liquicheck™ UrineToxicology Controls.
-
- Device The VITROS BARB assay is a homogeneous enzyme immunoassay that is description performed using the VITROS Chemistry Products BARB 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 BARB Reagent is a dual chambered package containing ready-to-use liquid reagents that are used to detect barbiturates 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 secobarbital, glucose-6-phosphate and nicotinamide adenine dinucleotide (NAD*), followed by Reagent 2 containing secobarbital labeled with the enzyme glucose-6phosphate dehydrogenase (G6P-DH). The assay is based on competition between barbiturates in the treated urine sample and secobarbital 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 barbiturates 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 Chemistry Products FS Calibrator 1 is prepared from sodium chloride and processed water. These standards are used to calibrate VITROS 5,1 FS Chemistry Systems for the qualitative and semiquantitative measurement of barbiturates (BARB).
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 BARB 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 market by 510(k) premarket notification (K031924). | |
| VITROS Chemistry Products BARB Reagent: For in vitro diagnostic use only. | |
| VITROS Chemistry Products BARB Reagent is used on VITROS 5,1 FS Chemistry Systems for the semi-quantitative or qualitative determination of barbiturates (BARB) in human urine using a cutoff of either 200 ng/mL or 300 ng/mL. | |
| Measurements obtained with the VITROS BARB method are used in the diagnosis and treatment of barbiturates use or overdose. | |
| The VITROS Chemistry Products BARB 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 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, 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.
The VITROS Chemistry Products BARB assay and VITROS Chemistry Products 7. Comparison to predicate DAT Performance Verifiers are substantially equivalent to the Syva® EMITOII Plus Barbiturate assay (K993987) and Bio-Rad Liquicheck™ Urine Toxicology Controls devices: (K022707) predicate devices which were cleared by the FDA for IVD use.
Continued on next page
3
The performance of the VITROS BARB assay on the VITROS 5,1 FS Chemistry System was compared to the Syva® EMIT II Plus Barbiturate assay on the SYVA 30R System. The results demonstrated good agreement between the two immunoassay methods.
The VITROS BARB assay and VITROS DAT Performance Verifiers have the following similarities to the predicate devices: same intended use, the same cutoff values of 200 or 300 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, secobarbital.
| Table 1 | ||
|---|---|---|
| DAT controls and the Syva EMIT II Plus Barbiturate 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 barbiturates in human urine. The controls are | ||
| assayed controls used to monitor the performance of Chemistry Systems. | ||
| Test Principle | Homogeneous enzyme immunoassay | |
| Cut-Off values | 200 or 300 ng/mL | |
| Specimen Type | Human Urine | |
| Reagent Format | Liquid ready to use | |
| Antibody source | Sheep polyclonal antibodies reactive to secobarbital | |
| Calibration traceability | Traceable to secobarbital with confirmation by GC/MS. | |
| Calibrator matrix | Human urine | |
| Control matrix | Human urine | |
| Device Differences | ||
| Device Characteristic | VITROS BARB assay | |
| (New device) | Emit® II Plus Barbiturates assay | |
| (Predicate device) | ||
| Calibrator levels | 6 levels | Qualitative: Three levels |
| Semi-quantitative: Five levels | ||
| Calibrator format | Frozen Liquid ready to use | Refrigerated liquid ready to use |
| Instrumentation | To be used on VITROS 5,1 FS | |
| Chemistry Systems | Multiple automated clinical chemistry | |
| systems | ||
| Controls: Drugs | ||
| Reported | 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), | ||
| phencyclid ine, propoxyphene, | ||
| nortriptyline and addition of creatinine, | ||
| pH, specific gravity. | ||
| Controls: Number of | ||
| Levels | Five | Two |
4
- The data presented in the premarket notification provide a reasonable assurance that 8. Conclusions the VITROS Chemistry Products BARB Reagent, VITROS Chemistry Products Calibrator Kit 26, VITROS Chemistry Products FS Calibrator 1, 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 U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized eagle-like symbol with three curved lines representing wings or feathers.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JAN 0 5 2007
Marlene Hanna Ortho-Clinical Diagnostics, Inc. 100 Indigo Creek Drive Rochester, NY 14626-5101
K062165 Re:
Trade/Device Name: VITROS Chemistry Products BARB Reagent VITROS Chemistry Products Calibrator Kit 26 VITROS Chemistry Products FS Calibrator 1 VITROS Chemistry Products DAT Performance Verifiers I, II, III, IV, and V Regulation Number: 21 CFR 862.3150 Regulation Name: Barbiturate test system Regulatory Class: Class II Product Code: DIS, DKB, DIF
Dated: December 20, 2006
Received: December 21, 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 conceming 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
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) 276-0490. 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.
Yéan 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
7
Indications for Use
510(k) Number (if known):
x062165
known):
Device Name: VITROS Chemistry Products BARB Reagent
For in vitro diagnostic use only. VITROS Chemistry Products BARB Indications for Reagent is used on VITROS 5,1 FS Chemistry Systems for the semi-Use: quantitative or qualitative determination of barbiturates (BARB) in human urine using a cutoff of either 200 ng/mL or 300 ng/mL. Measurements obtained with the VITROS BARB method are used in the diagnosis and treatment of barbiturates use or overdose.
The VITROS Chemistry Products BARB 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)
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
SNG(K) K062165
Page 1 of 2
8
Indications for Use
Page 2 of 2
| 510(k) Number (if known): | K062165 |
|---|---|
| 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 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 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 | X |
| Over-The-Counter Use | |
| AND/OR | |
(Part 21 CFR 801 Subpart D)
(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
062/65