(114 days)
Not Found
No
The document describes a standard enzyme immunoassay and associated reagents and calibrators for detecting cocaine metabolites. There is no mention of AI or ML in the intended use, device description, or performance studies. The analysis is based on spectrophotometric measurement of enzyme activity, a traditional biochemical method.
No.
The device is for in vitro diagnostic use only and is used to detect cocaine metabolites in human urine. It is not intended for the treatment or diagnosis of
disease directly.
Yes
The text explicitly states: "For in vitro diagnostic use only." and "Measurements obtained with the VITROS COCM method are used in the diagnosis and treatment of cocaine use or overdose."
No
The device description clearly outlines physical reagents (VITROS Chemistry Products COCM Reagent, Calibrator Kit 26, FS Calibrator 1, FS Diluent Pack 4, DAT Performance Verifiers) 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.
- Nature of the Test: The device is used to determine the presence of benzoylecgonine (cocaine metabolites) in human urine. This is a test performed on a sample taken from the body, outside of the body, which is the definition of "in vitro."
- Purpose of the Test: The measurements are used "in the diagnosis and treatment of cocaine use or overdose." This clearly indicates a diagnostic purpose.
- Intended User: The assay is intended for "professional laboratory personnel," which is typical for IVD devices.
- Device Description: The description details a chemical assay performed on a laboratory instrument, further supporting its use in a laboratory setting for diagnostic testing.
N/A
Intended Use / Indications for Use
For in vitro diagnostic use only. VITROS Chemistry Products COCM Reagent is used on VITROS 5,1 FS Chemistry Systems for the semiquantitative or qualitative determination of benzoylecgonine (cocaine metabolite) in human urine using a cutoff of either a 150 ng/mL or a 300 ng/mL. Measurements obtained with the VITROS COCM method are used in the diagnosis and treatment of cocaine use or overdose.
The VITROS Chemistry Products COCM 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.
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.
Product codes (comma separated list FDA assigned to the subject device)
DIO, DKB, DIF
Device Description
The VITROS COCM assay is a homogeneous enzyme immunoassay that is performed using the VITROS Chemistry Products COCM 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 COCM Reagent is a dual chambered package containing ready-to-use liquid reagents that are used to detect benzoylecgonine (cocaine metabolite) 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 benzoylecgonine, glucose-6-phosphate and nicotinamide adenine dinucleotide (NAD+), followed by Reagent 2 containing benzoylecgonine labeled with the enzyme glucose-6-phosphate dchydrogenase (G6P-DH). The assay is based on competition between benzoylecgonine in the treated urine sample and benzoylecgonine 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 benzoylecgonine 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. The VITROS Chemistry Products FS Calibrator 1 is composed of processed water and 0.9% w/v sodium chloride (Saline). These calibrators are used in combination to calibrate VITROS 5.1 FS Chemistry Systems for the qualitative or semi-quantitative measurement of benzoylecgonine (cocaine metabolites) in urine.
The 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 COCM 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. Diluent 1 is prepared from processed water to which inorganic salt has 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 mstrament that provieds and MicroSlides® range of products. The VITROS 5,1 FS System was cleared for market 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Correlation studies and bench testing were performed. Bench testing was performed to determine assay precision, linearity, specificity, expected values, limit of detection, dilution, stability, and specimen matrix of the VITROS COCM assay. The performance of the VITROS COCM assay on the VITROS 5,1 FS Chemistry System was compared to the Syva® Emit® II Plus Cocaine Metabolite assay. The results demonstrated good agreement between the two immunoassay methods. Equivalence to the predicates was demonstrated using a commercially available assay along with patient samples.
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.
Not Found
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
§ 862.3250 Cocaine and cocaine metabolite test system.
(a)
Identification. A cocaine and cocaine metabolite test system is a device intended to measure cocaine and a cocaine metabolite (benzoylecgonine) in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of cocaine use or overdose.(b)
Classification. Class II (special controls). A cocaine and cocaine metabolite 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 stylized symbol on the left, followed by the text "Ortho-Clinical Diagnostics". The text is underlined with a thin line. The overall design is simple and professional.
a Yolinon-Johnton company 100 Indigo Creck Drive Rochester, New York 14626-5101
NUV 16 2006
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: KO62123
- Submitter Ortho-Clinical Diagnostics, Inc. name, 100 Indigo Creek Drive address. Rochester, New York 14626-5101 contact (585) 453-3143 Contact Person: Michael Byrne
-
- Preparation July 24, 2006 Date
3. Device name Trade or Proprietary Names:
VITROS Chemistry Products COCM 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:
COCM assay and controls
Classification Names:
Cocaine and cocaine metabolite test system (862.3250) Class II; Clinical toxicology calibrators (862.3200) Class II; Clinical toxicology control material (862.3280) Class I (general controls). Since these devices (VITROS DAT Performance Verifiers I, II, III, IV, & V) are assayed controls, they meet the reserved criteria under Section 510(1) of the Food, Drug, and Cosmetic Act.
Continued on next page
1
-
The VITROS Chemistry Products COCM assay is substantially 4. Predicate equivalent to the previously cleared Syva® Emit® II Plus Cocaine Devices Metabolite assay (K031512).
The VITROS Chemistry Products DAT Performance Verifiers are substantially equivalent to the previously cleared Liquichek™ Urine Toxicology Control Levels S1E and S2E (K022707). -
The VITROS COCM assay is a homogeneous enzyme immunoassay 5. Device that is performed using the VITROS Chemistry Products COCM description Reagent with the VITROS Chemistry Products Calibrator Kit 26, VITROS Chemistry Products FS Calibrator 1, and VITROS Chemistry Products FS Diluent Pack 4 (DAT Diluent / DAT Diluent 2) on VITROS 5.1 FS Chemistry Systems.
The VITROS COCM Reagent is a dual chambered package containing ready-to-use liquid reagents that are used to detect benzoylecgonine (cocaine metabolite) 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 benzoylecgonine, glucose-6-phosphate and nicotinamide adenine dinucleotide (NAD+), followed by Reagent 2 containing benzoylecgonine labeled with the enzyme glucose-6-phosphate dehydrogenase (G6P-DH). The assay is based on competition between benzoylecgonine in the treated urine sample and benzoylecgonine labeled with the enzyme glucose-6-phosphate dchydrogenase (G6P-DH) for antibody binding sites. Enzyme activity decreases upon binding to the antibody, therefore the concentration of benzoylecgonine 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. The VITROS Chemistry Products FS Calibrator 1 is composed of processed water and 0.9% w/v sodium chloride (Saline). These calibrators are used in combination to calibrate VITROS 5.1 FS Chemistry Systems for the qualitative or semi-quantitative measurement of benzoylecgonine (cocaine metabolites) in urine.
The 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 COCM assay on VITROS 5,1 FS Chemistry Systems.
Continued on next page
2
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. Diluent 1 is prepared from processed water to which inorganic salt has 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 mstrament that provieds and MicroSlides® range of products. The VITROS 5,1 FS System was cleared for market by 510(k) premarket notification (K031924).
- Device intended uses
VITROS Chemistry Products COCM Reagent: For in vitro diagnostic use only. VITROS Chemistry Products COCM Reagent is used on VITROS 5,1 FS Chemistry Systems for the semi-quantitative or qualitative determination of benzoylecgonine (cocaine metabolites) in human urine using a cutoff of cither a 150 ng/mL or a 300 ng/mL. Measurements obtained with the VITROS COCM method are used in the diagnosis and treatment of cocaine use or overdose.
The VITROS Chemistry Products COCM assay is intended for use by professional laboratory personnel. It provides only a preliminary test result. A more specific alternative chemical method must be used to confirm a result obtained with this assay. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drugof-abuse test result, particularly when evaluating a preliminary positive result.
VITROS Chemistry Products Calibrator Kit 26: For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 26 is used to calibrate VITROS 5,1 FS Chemistry Systems for the qualitative or semi-quantitative measurement of drugs of abuse.
VITROS Chemistry Products FS Calibrator 1: For in vitro diagnostic use only. VITROS Chemistry Products FS Calibrator 1 is used in conjunction with VITROS Chemistry Products Calibrator Kits to calibrate VITROS 5,1 FS Chemistry Systems.
VITROS Chemistry Products DAT Performance Verifiers I, II, III, IV & 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.
3
7. Comparison The VITROS Chemistry Products COCM Reagent and the VITROS Chemistry Products Calibrator Kit 26 used in conjunction with VITROS to predicate FS Calibrator 1 (VITROS Chemistry Products COCM Assay) are substantially equivalent to the Syva® Emit® II Plus Cocaine Metabolite devices: assay (predicate device) which was cleared by the FDA for IVD use (K031512).
The performance of the VITROS COCM assay on the VITROS 5,1 FS Chemistry System was compared to the Syva® Emit® II Plus Cocaine Metabolite assay. The results demonstrated good agreement between the two immunoassay methods.
The VITROS Chemistry Products DAT Performance Verifiers I. III. IV, & V are substantially equivalent to the Liquichek™M Urine Toxicology Control Levels SIE and S2E (predicate device) which were cleared by the FDA for IVD use (K022707).
In addition to correlation studies, bench testing was performed to determine assay precision, linearity, specificity, expected values, limit of detection, dilution, stability, and specimen matrix of the VITROS COCM assay.
Similarities and differences of the assays performed using the VITROS COCM Table 1 assay and the Syva® Emit® II Plus Cocaine Metabolite assay.
| Device Similarities | ||
|---|---|---|
| Device Characteristic | Description | |
| Indications for Use | For in vitro diagnostic use only. The assays are intended for use in the semi-quantitative or qualitative determination of benzoylecgonine (cocaine metabolites) in human urine. | |
| Test Principle | Homogeneous enzyme immunoassay | |
| Cut-Off values | 150 and 300 ng/mL | |
| Specimen Type | Human Urine | |
| Reagent Format | Liquid ready to use | |
| Antibody source | Sheep polyclonal antibodies reactive to benzoylecgonine | |
| Calibration traceability | Benzoylecgonine, nominal values confirmed by GC/MS | |
| Calibrator matrix | Human urine | |
| Device Differences | ||
| Device Characteristic | VITROS COCM assay (New device) | Syva® Emit® II Plus Cocaine Metabolite assay (Predicate device) |
| Reportable Range | 50 – 1000 ng/ml | 45 – 900 ng/mL |
| Calibrator levels | Six levels | Qualitative: Three levels |
| Semi-quantitative: Five levels | ||
| Calibrator format | Frozen: liquid ready to use | Refrigerated: liquid ready to use |
| Instrumentation | VITROS 5,1 FS Chemistry System | Multiple automated clinical chemistry systems |
4
- Table 2 Similarities and differences of the device characteristics between the VITROS DAT Performance Verifiers I, II, III, IV, and V with the predicate device Liquichek™ Urine Toxicology Control Levels S1E and S2E.
| Device Similarities | ||
|---|---|---|
| Device | ||
| Characteristic | Description | |
| Matrix | Human Urine | |
| Format | Liquid, ready to use | |
| Device Differences | ||
| Device | ||
| Characteristic | Description | |
| VITROS DAT Performance | ||
| Verifiers (New Device) | Bio-Rad Liquichek Urine Toxicology | |
| Control | ||
| Analytes Reported | Amphetamines (d- | |
| Methamphetamine), Barbiturates | ||
| (Secobarbitol), Benzodiazepines | ||
| (Lormetazepam), Cannabinoids | ||
| (THC), Cocaine | ||
| (Benzoylecgonine), Methadone, | ||
| Opiates (Morphine), | ||
| Phencyclidine, Propoxyphene. | Amphetamines (d-Methamphetamine), | |
| Barbiturates (Secobarbitol), | ||
| Benzodiazepines (Lormetazepam), | ||
| Cannabinoids (THC), Cocaine | ||
| (Benzoylecgonine), Ethanol, Lysergic | ||
| Acid Diethylamide (LSD), Methadone, | ||
| Methaqualone, Opiates (Morphine), | ||
| Phencyclidine, Propoxyphene, Tricyclic | ||
| Antidepressants (Nortriptyline) and | ||
| addition of creatinine, and adjustment of | ||
| pH, and specific gravity | ||
| Levels | Five | Two |
-
- Conclusions The data presented in the premarket notification provide a reasonable assurance that the VITROS Chemistry Products COCM Reagent, VITROS Chemistry Products Calibrator Kit 26 used in conjunction with 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
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 stylized eagle with three lines representing its wings and body. The eagle is enclosed in a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is written around the circle.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
NOV 1 6 2006
Mr. Michael M. Byrne Regulatory Affairs Associate Ortho-Clinical Diagnostics 100 Indigo Creek Rochester, NY 14626
Re: K062123 Trade/Device Name: VITROS Chemistry Products COCM Reagent Regulation Number: 21 CFR 862.3650 Regulation Name: Opiate test system Regulatory Class: Class II Product Code: DIO, DKB, DIF Dated: September 26, 2006 Received: September 28, 2006
Dear Mr. Byrne:
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 (scc 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) I his letter will anow you to begin maneering your and equivalence of your device to a legally prematics notification. "The I DTP intentig cification 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, If you desne specific information actually of your device, please contact the Office of In of questions on the promotion and Safety at (240) 276-0484. Also, please note the v Into Diagnostic Dovio Dranading by reference to premarket notification" (21CFR Part 807.97). Tou may obtain other general information on your responsibilities under the Act from the I ou may ootan other general meethesis 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,
Alberto Gutierrez, 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):
Device Name: VITROS Chemistry Products COCM Reagent
Indications for For in vitro diagnostic use only. VITROS Chemistry Products COCM Use: Reagent is used on VITROS 5,1 FS Chemistry Systems for the semiquantitative or qualitative determination of benzoylecgonine (cocaine metabolite) in human urine using a cutoff of either a 150 ng/mL or a 300 ng/mL. Measurements obtained with the VITROS COCM method are used in the diagnosis and treatment of cocaine use or overdose.
The VITROS Chemistry Products COCM 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)
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)
Carol Benson
Vision Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
Page 1 of 2
8
Indications for Use
Page 2 of 2
510(k) Number (if known):
ber K062123
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
For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Indications for Kit 26 is used to calibrate VITROS 5,1 FS Chemistry Systems for the Use: 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 (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)
Caul Beman
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
K06212-3