VITROS CHEMISTRY PRODUCTS PCP REAGENT, CALIBRATOR KIT 26, FS CALIBRATOR 1, DAT PERFORMANCE VERIFIERS I, II, III, IV, & V

Q: Who is the manufacturer of VITROS CHEMISTRY PRODUCTS PCP REAGENT, CALIBRATOR KIT 26, FS CALIBRATOR 1, DAT PERFORMANCE VERIFIERS I, II, III, IV, & V?

Ortho-Clinical Diagnostics, Inc. filed the 510(k) submission for VITROS CHEMISTRY PRODUCTS PCP REAGENT, CALIBRATOR KIT 26, FS CALIBRATOR 1, DAT PERFORMANCE VERIFIERS I, II, III, IV, & V (K062094).

Q: What is the FDA product code for VITROS CHEMISTRY PRODUCTS PCP REAGENT, CALIBRATOR KIT 26, FS CALIBRATOR 1, DAT PERFORMANCE VERIFIERS I, II, III, IV, & V?

LCM. as a Class U device in the CH panel.

Q: What is the regulatory pathway for VITROS CHEMISTRY PRODUCTS PCP REAGENT, CALIBRATOR KIT 26, FS CALIBRATOR 1, DAT PERFORMANCE VERIFIERS I, II, III, IV, & V?

510(k) clearance (submission type: Traditional).

Q: Who can help prepare an FDA 510(k) submission like VITROS CHEMISTRY PRODUCTS PCP REAGENT, CALIBRATOR KIT 26, FS CALIBRATOR 1, DAT PERFORMANCE VERIFIERS I, II, III, IV, & V?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

K062094 · Ortho-Clinical Diagnostics, Inc. · LCM · Nov 22, 2006 · CH

Device Facts

Record ID	K062094
Device Name	VITROS CHEMISTRY PRODUCTS PCP REAGENT, CALIBRATOR KIT 26, FS CALIBRATOR 1, DAT PERFORMANCE VERIFIERS I, II, III, IV, & V
Applicant	Ortho-Clinical Diagnostics, Inc.
Product Code	LCM · CH
Decision Date	Nov 22, 2006
Decision	SESE
Submission Type	Traditional
Device Class	Class U

Intended Use

VITROS Chemistry Products PCP Reagent: For in vitro diagnostic use only. VITROS Chemistry Products PCP Reagent is used on VITROS 5,1 FS Chemistry Systems for the semi-quantitative or qualitative determination of phencyclidine (PCP) in human urine using a cutoff of 25 ng/mL. Measurements obtained with the VITROS PCP method are used in the diagnosis and treatment of phencyclidine use or overdose. The VITROS Chemistry Products PCP 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, 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.

Device Story

The VITROS PCP assay is a homogeneous enzyme immunoassay performed on the VITROS 5,1 FS Chemistry System. It utilizes liquid reagents, calibrators, and controls. The process involves treating urine samples with surfactant, followed by the addition of an antibody-reactive reagent and an enzyme-labeled phencyclidine reagent. The assay relies on competitive binding between phencyclidine in the sample and enzyme-labeled phencyclidine for antibody sites. Enzyme activity is inversely proportional to the concentration of phencyclidine in the sample. The active enzyme converts NAD to NADH, producing an absorbance change measured spectrophotometrically at 340 nm. The system is operated by professional laboratory personnel in a clinical setting. Results are used by clinicians to aid in the diagnosis and treatment of drug use or overdose. The device provides preliminary screening results that require confirmation by a more specific method, such as GC/MS.

Clinical Evidence

No clinical trials were performed. Substantial equivalence was demonstrated through bench testing comparing the VITROS PCP assay performance on the VITROS 5,1 FS Chemistry System against the predicate Syva EMIT II Plus Phencyclidine assay on the Syva 30R Biochemical System. Results showed good agreement between the two immunoassay methods.

Technological Characteristics

Homogeneous enzyme immunoassay; spectrophotometric detection at 340 nm. Reagents are liquid, ready-to-use. Uses sheep polyclonal antibodies. Calibrators and controls are human urine-based. Operates on the VITROS 5,1 FS Chemistry System (K031924).

Indications for Use

Indicated for the qualitative or semi-quantitative determination of phencyclidine (PCP) in human urine for the diagnosis and treatment of PCP use or overdose. Intended for professional laboratory use only. Provides preliminary results requiring confirmation by GC/MS.

Predicate Devices

DADE BEHRING Syva® EMIT® II Plus Phencyclidine Assay (K993983)
BIO-RAD Liquichek™ Urine Toxicology Controls (K022707)

Related Devices

K020254 — PHENCYCLIDINE ENZYME IMMUNOASSAY, CATALOG NUMBERS 0010 & 0011 · Lin-Zhi International, Inc. · May 10, 2002
K993983 — SYVA EMIT II PLUS PHENCYCLIDINE ASSAY, MODEL 9J029UL · Syva Co. · Jan 27, 2000
K013096 — PHENCYCLIDINE · Abbott Laboratories · Mar 13, 2002
K163220 — Atellica CH Phencyclidine (Pcp) · Siemens Healthcare Diagnostics, Inc. · Apr 6, 2017
K983704 — MODIFICATION TO ABUSCREEN ONLINE FOR PHENCYCLIDINE · Roche Diagnostic Systems, Inc. · Feb 10, 1999

Submission Summary (Full Text)

{0}------------------------------------------------ Not & & 200h Image /page/0/Picture/1 description: The image shows the logo for Ortho-Clinical Diagnostics. The logo consists of a stylized symbol to the left of the text "Ortho-Clinical Diagnostics". The symbol appears to be a stylized representation of a medical or scientific emblem. The text is in a simple, sans-serif font, with "Ortho-Clinical" on the top line and "Diagnostics" on the bottom line. **Johnson-Johnson company** 100 Indigo Creek Drive Rochester, New York 14626-5101 ### 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: ب 06 -2 06 -2 09 4 Ortho-Clinical Diagnostics, Inc. 1. Submitter 100 Indigo Creek Drive name, Rochester, New York 14626-5101 address. (585) 453-4253 contact Contact Person: Darlene Phillips 2. Preparation September 28, 2006 Date 3. Device name Trade or Proprietary Names: VITROS Chemistry Products PCP Reagent VITROS Chemistry Products Calibrator Kit 26 VITROS Chemistry Products FS Calibrator 1 VITROS Chemistry Products DAT Performance Verifiers I, II, & V Common Names: Phencyclidine (PCP) assay and controls Classification Names: Phencyclidine test system (862.3100) 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. 4. Predicate The VITROS Chemistry Products PCP assay is substantially equivalent to the DADE BEHRING Syva® EMIT® II Plus Phencyclidine 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}------------------------------------------------ # 5. Device The VITROS PCP assay is a homogeneous enzyme immunoassay that is description performed using the VITROS Chemistry Products PCP 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 PCP Reagent is a dual chambered package containing ready-to-use liquid reagents that are used to detect phencyclidine in urine. Samples, 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 phencyclidine, glucose-6-phosphate and nicotinamide adenine dinucleotide (NAD), followed by Reagent 2 containing phencyclidine labeled with the enzyme glucose-6-phosphate dehydrogenase (G6P-DH). The assay is based on competition between phencyclidine in the treated urine sample and phencyclidine labeled with the enzymc glucose-6-phosphate dehydrogenase (G6P-DH) for antibody binding sites. Enzyme activity decreases upon binding to the antibody, therefore the concentration of phencyclidine 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 FS Calibrator 1 is prepared from sodium chloride and processed water. VITROS Calibrator Kit 26 is used in conjunction with VITROS FS Calibrator 1 to calibrate VITROS 5.1 FS Chemistry Systems for the qualitative or semi-quantitative measurement of phencyclidine (PCP). VITROS Chemistry Products DAT Performance Verifiers I. II, and V are prepared from a human urine pool to which analytes, surfactant, and preservative have been added. These are assaved controls used to monitor performance of the VITROS PCP assay on VITROS 5,1 FS Chemistry Systems. Continued on next page {2}------------------------------------------------ . | 4. Device description (continued) | The VITROS Chemistry Products FS Diluent Pack 4 (DAT Diluent/ DAT Diluent 2) is a common reagent that is used with several drugs of abuse assays to dilute calibrators and samples on the VITROS 5,1 FS System. This is a dual chambered package containing two ready-to-use liquid diluents. DAT Diluent is prepared from human urine to which organic salt, surfactants, and preservative have been added. DAT Diluent 2 is prepared from processed water to which surfactant and preservative have been added. | |-----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | The VITROS 5,1 FS Chemistry System is a clinical chemistry instrument that provides automated use of the VITROS Chemistry Products MicroTip® and MicroSlides® range of products. The VITROS 5,1 FS System was cleared for market by 510(k) premarket notification (K031924). | | 6. Device intended uses | VITROS Chemistry Products PCP Reagent: For in vitro diagnostic use only. VITROS Chemistry Products PCP Reagent is used on VITROS 5,1 FS Chemistry Systems for the semi-quantitative or qualitative determination of phencyclidine (PCP) in human urine using a cutoff of 25 ng/mL. Measurements obtained with the VITROS PCP method are used in the diagnosis and treatment of phencyclidine use or overdose. | | | The VITROS Chemistry Products PCP 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, 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. | | | Continued on next page | ______________________________________________________________________________________________________________________________________________________________________________ - {3}------------------------------------------------ #### 7. Comparison The VITROS Chemistry Products PCP assay and VITROS Chemistry to predicate Products DAT Performance Verifiers are substantially equivalent to the DADE BEHRING Syva® EMIT® II Plus Phencyclidine Assay devices (K993983) and BIO-RAD Liquichek" 31 Urine Toxicology Controls (K022707) (predicate devices) which were cleared by the FDA for in vitro diagnostic use. The performance of the VITROS PCP assay on the VITROS 5.1 FS Chemistry System was compared to the Syva® EMIT® II Plus Phencyclidine assay on the Syva® 30R Biochemical System. The results demonstrated good agreement between the two immunoassay methods. The VITROS PCP assay and the VITROS DAT Performance Verificrs have the following similarities to the predicate devices: the same intended use, the same cutoff value of 25 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, phencyclidine. - Similarities and differences of the assays performed using the VITROS Table 1 PCP assay and the VITROS DAT Performance Verifiers and the EMIT® Phencyclidine assay and BIO-RAD® Liquichek114 Urine Toxicology Controls. | Device Similarities | | |--------------------------|------------------------------------------------------------------------------------------------------------------------| | Device Characteristic | Description | | Indications for Use | The assays are intended for use in the qualitative and semi- quantitative analysis of phencyclidine in human urine. | | Calibration traceability | Phencyclidine with confirmation by GC/MS | | Cut-Off value | 25 ng/mL | | Sample Type | Human Urine | | Reagent Format | Liquid ready to use | | Antibody source | Sheep polyclonal antibodies reactive to phencyclidine | | Calibration traceability | Phencyclidine with confirmation by GC/MS | | Calibrator matrix | Human urine | | Control matrix | Human urine | Continued on next page {4}------------------------------------------------ | Differences | | | |---------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Characteristic | VITROS PCP assay (New device) | EMIT® Phencyclidine assay and Liquichek™ Urine Toxicology Controls (Predicate devices) | | Reportable Range | 6.0 - 72.0 ng/mL | 8 - 90 ng/mL | | Calibrator: Number of levels | Five | Qualitative: Three Semi-quantitative: Five | | 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 | | 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 | Three | Two | - 8. Conclusions The data presented in the premarket notification provide a reasonable assurance that the VITROS Chemistry Products PCP Reagent, VITROS Chemistry Products Calibrator Kit 26, VITROS Chemistry Products FS Calibrator 1 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 logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the symbol. The logo is black and white. Public Health Service Food and Druq Administration 2098 Gaither Road Rockville MD 20850 Ms. Darlene Phillips Ortho-Clinical Diagnostics, Inc. 100 Indigo Creek Drive Rochester, New York 14626-5101 NOV 2 2 2006 Rc: k062094 Trade/Device Name: VITROS Chemistry Products PCP Reagent Regulation Number: Unclassified Regulation Name: Enzyme immunoassay, phencyclidine Regulatory Class: 510(k) required Product Code: LCM, DKB, DIF Dated: September 28, 2006 Received: September 29, 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 yours, Alberto Garcia 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 Page 1 of 2 510(k) Number (if known): KOG 2094 Device Name: VITROS Chemistry Products PCP Reagent Indications For in vitro diagnostic use only. VITROS Chemistry Products PCP for Use: Reagent is used on VITROS 5,1 FS Chemistry Systems for the semiquantitative or qualitative determination of phencyclidine (PCP) in human urine using a cutoff of 25 ng/mL. Measurements obtained with the VITROS PCP method are used in the diagnosis and treatment of phencyclidine use or overdose. > The VITROS Chemistry Products PCP 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) Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safe KD62094 {8}------------------------------------------------ Indications for Use Page 2 of 2 510(k) Number (if known): KO62094 Device Name: VITROS Chemistry Products Calibrator Kit 26 VITROS Chemistry Products FS Calibrator 1 VITROS Chemistry Products DAT Performance Verifiers I, II, and V Indications For in vitro diagnostic use only. VITROS Chemistry Products Calibrator for Use: Kit 26 is used to calibrate VITROS 5,1 FS Chemistry Systems for the qualitative or semi-quantitative mcasurement 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 _______________ AND/OR Over-The-Counter Use __ (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 Dirgnostic Device Evaluation and Safe K062094