MODIFICATION TO ABUSCREEN ONLINE FOR PHENCYCLIDINE

K983704 · Roche Diagnostic Systems, Inc. · JCM · Feb 10, 1999 · Hematology

Device Facts

• Record ID: K983704
• Device Name: MODIFICATION TO ABUSCREEN ONLINE FOR PHENCYCLIDINE
• Applicant: Roche Diagnostic Systems, Inc.
• Product Code: JCM · Hematology
• Decision Date: Feb 10, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.7415
• Device Class: Class 2

Intended Use

Abuscreen ONLINE for Phencyclidine is an in vitro diagnostic test for the qualitative and semiquantitative detection of phencyclidine and its metabolites in human urine on the Hitachi 917 analyzer at a cutoff concentration of 25 ng/mL. Semiquantitative test results may be obtained that permit laboratories to assess assay performance as part of a quality control program. Measurements obtained by this device are used in the diagnosis of phencyclidine use or abuse.

Device Story

Abuscreen ONLINE Phencyclidine is an in vitro diagnostic immunoassay for detecting phencyclidine and metabolites in human urine. The device utilizes kinetic interaction of microparticles in solution, measured by changes in light transmission on the Hitachi 917 automated clinical chemistry analyzer. The assay employs a monoclonal mouse antibody reagent and conjugated phencyclidine derivative microparticles. The system automates sample processing, photometric measurement, and result transmission. Results are used by clinicians to diagnose phencyclidine use or abuse. Semiquantitative results assist laboratories in quality control assessment. The device is intended for professional use in clinical laboratory settings.

Clinical Evidence

Bench testing only. Precision studies evaluated within-run and day-to-day performance at 12.5, 18.75, 25.0, 31.25, and 37.5 ng/mL concentrations. Accuracy was assessed using 50 confirmed positive samples and 28 samples diluted near the 25 ng/mL cutoff (14 above, 14 below). Results showed 100% agreement with expected qualitative outcomes. Limit of detection reported as 0.6 ng/mL.

Technological Characteristics

In vitro diagnostic immunoassay. Methodology: kinetic interaction of microparticles measured by light transmission. Reagents: monoclonal mouse anti-phencyclidine antibody, conjugated phencyclidine derivative microparticles, and buffer/surfactant diluent. Form factor: reagent kit for automated clinical chemistry analyzer (Hitachi 917).

Indications for Use

Indicated for the qualitative and semiquantitative detection of phencyclidine and its metabolites in human urine for the diagnosis of phencyclidine use or abuse. Intended for use on the Hitachi 917 analyzer.

Regulatory Classification

Identification

An abnormal hemoglobin assay is a device consisting of the reagents, apparatus, instrumentation, and controls necessary to isolate and identify abnormal genetically determined hemoglobin types.

Special Controls

*Classification.* Class II (special controls). A control intended for use with an abnormal hemoglobin assay is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.

Predicate Devices

• Abuscreen ONLINE for Phencyclidine (K920935)

Reference Devices

• Hitachi 917 Analyzer System (K953239)

Submission Summary (Full Text)

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2/10/99

K983704

Roche

# 510(k) Summary

# Abuscreen ONLINE® Phencyclidine

In accordance with the Safe Medical Devices Act of 1990, a 510(k) summary is provided as outlined in 21 CFR 807.92.

The assigned 510(k) number is: K983704

#### Identification of 510(k) Sponsor: I.

Roche Diagnostic Systems, Inc. a subsidiary of Hoffmann-La Roche, Inc. Branchburg Township 1080 U.S. Highway 202 Somerville, New Jersey 08876-3771

510(k) Submission dated October 20, 1998

Rita Smith Contact: Senior Regulatory Affairs Associate Phone: [phone] [phone] Fax:

Roche Diagnostic Systems, Inc.

Branchburg Township 1080 U.S. Highway 202 Somerville, New Jersey 08876-3771

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#### Device Name: II.

The device name, including both the trade/proprietary name and the classification name are provided in the table below.

## Table 1

| Product Name | Classification<br>Name | Product<br>Code | CFR<br>Number and<br>Regulatory Class |
|---------------------------------------|--------------------------------------|-----------------|---------------------------------------|
| Abuscreen ONLINE for<br>Phencyclidine | Enzyme Immunoassay,<br>Phencyclidine | LCM | not<br>available |

### III. Identification of the legally marketed device to which the 510(k) sponsor claims equivalence:

The following table identifies the legally marketed devices to which Roche Diagnostic Systems, Inc. claims equivalence.

## Table 2

| Product Name | Predicate Product Name | 510(k) Number and Date<br>Predicate Cleared |
|---------------------------------------|---------------------------------------|---------------------------------------------|
| Abuscreen ONLINE for<br>Phencyclidine | Abuscreen ONLINE for<br>Phencyclidine | K920935 3/18/92 |

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#### Description of the Device/Statement of Intended Use: IV.

Abuscreen ONLINE for Phencyclidine is an in vitro diagnostic test for the qualitative and semiquantitative detection of phencyclidine and its metabolites in human urine on automated clinical chemistry analyzers at a cutoff concentration of 25 ng/mL. Semiquantitative test results may be obtained that permit laboratories to assess assay performance as part of a quality control program. Measurements obtained by this device are used in the diagnosis of phencyclidine use or abuse.

The proposed Abuscreen ONLINE Phencyclidine test kit is specifically intended for use on the Hitachi 917 Analyzer and future similar analyzer models. It was adapted from the currently marketed Abuscreen ONLINE Phencyclidine test kit. The labeling and packaging have been changed for use on the Hitachi 917 Analyzer as well as an addition of a surfactant to the diluent. This modified test kit is not a replacement to the currently marketed kit.

The Hitachi 917 Analyzer System is a fully automatic, computer-controlled system for clinical chemistry. It was conceived for both quantitative and qualitative in vitro determination using a large variety of tests for analysis, e.g. in serum and urine. Integrated in the system is an ion-selective unit for determination of electrolytes. The throughput per hour is 800 tests for clinical chemistry (1200 with electrolytes). The system consists of the analyzer which performs all functions required for fully automatic sample and testprocessing. Beginning with the automatic recording of patient samples - provided that they are supplied in barcode-labeled vessels - up to the photometric measurement and results transmission to the computer unit. Additional detailed information about the Hitachi 917 Analyzer is contained in volume II of the premarket notification (K953239) cleared on September 25, 1995.

### V. Summary of the technological characteristics of the new device in comparison to those of the predicate.

Tables 3 outlines the technological characteristics (methodologies) of the Abuscreen ONLINE Phencyclidine in comparison to those of the legally marketed product.

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### VI. Brief discussion of the clinical and nonclinical tests relied on for a determination of substantial equivalence:

Tables 3 demonstrates the results of clinical and nonclinical studies performed using the Abuscreen ONLINE Phencyclidine. The significant performance characteristics relied upon for a determination of substantial equivalence are summarized in this chart. This information concludes that the performance of this device is essentially equivalent to the legally marketed predicate device.

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## Abuscreen ONLINE Phencyclidine for Hitachi 917 Table 3

| | Proposed: | | Previously Cleared: (K920935) | |
|--------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| | Abuscreen ONLINE | | Abuscreen ONLINE | |
| | Phencyclidine for Hitachi 917 | | Phencyclidine (1000 Test Kit) | |
| Methodology | Kinetic interaction of<br>microparticles in a solution as<br>measured by changes in light<br>transmission | | Kinetic interaction of<br>microparticles in a solution as<br>measured by changes in light<br>transmission | |
| Sample type | urine | | urine | |
| Intended Use | qualitative and semiquantitative<br>detection of phencyclidine and<br>its metabolites | | qualitative detection of<br>phencyclidine and its<br>metabolites | |
| Calibrator | Abuscreen ONLINE Calibration<br>Pack or Abuscreen ONLINE<br>Calibrator Level 3 | | Abuscreen ONLINE Calibration<br>Pack or Abuscreen ONLINE<br>Calibrator Level 3 | |
| Cutoff(s) | 25 ng/mL | | 25 ng/mL | |
| Reagent (active<br>ingredients) | 1. Ab reagent: phencyclidine<br>monoclonal (mouse) antibody in<br>buffer<br>2. Microparticle reagent:<br>Conjugated phencyclidine<br>derivative microparticles in<br>buffer<br>3. Diluent: Buffer | | 1. Ab reagent: phencyclidine<br>monoclonal (mouse) antibody in<br>buffer<br>2. Microparticle reagent:<br>Conjugated phencyclidine<br>derivative microparticles in<br>buffer<br>3. Diluent: Buffer | |
| Performance Characteristics: | | | | |
| Precision Qualitative ( 25 ng/mL Cutoff ): | >95% negative at 18.75 ng/mL<br>>95% positive at 31.25 ng/mL | | >95% negative at 20 ng/mL<br>>95% positive at 30 ng/mL | |
| | Mean (OD) | CV% | | |
| Within Run | | | | |
| 12.5 ng/mL | 7842 | 2.9 | | |
| 18.75 ng/mL | 6858 | 3.3 | | |
| 25.0 ng/mL | 5655 | 1.8 | | |
| 31.25 ng/mL | 4525 | 2.0 | | |
| 37.5 ng/mL | 3732 | 1.2 | | |
| Day-to-Day | Mean (OD) | CV% | | |
| 12.5 ng/mL | 7516 | 3.3 | | |
| 18.75 ng/mL | 6595 | 4.8 | | |
| 25.0 ng/mL | 5385 | 3.5 | | |
| 31.25 ng/mL | 4402 | 3.3 | | |
| 37.5 ng/mL | 3622 | 3.1 | | |

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# Abuscreen ONLINE Phencyclidine for Hitachi 917 Table 3 (Continued)

| | Proposed: | | Previously Cleared: (K920935) | | |
|---------------------------------------------|--------------------------------------------------------------------------|-----|-----------------------------------------|--------------|-----|
| | Abuscreen ONLINE | | Abuscreen ONLINE Phencyclidine | | |
| | Phencyclidine for Hitachi 917 | | (1000 Test Kit) | | |
| Precision Quantitative ( 25 ng/mL Cutoff ): | | | | | |
| Within Run | Mean (ng/mL) | CV% | Conc. (ng/mL) | Mean (ng/mL) | CV% |
| 12.5 ng/mL | 12.1 | 6.2 | 12.5 | 12 | 7 |
| 18.75 ng/mL | 15.7 | 4.3 | 18.75 | 19 | 6 |
| 25.0 ng/mL | 25.6 | 2.0 | 25.0 | 24 | 3 |
| 31.25 ng/mL | 30.8 | 2.1 | 31.25 | 27 | 3 |
| 37.5 ng/mL | 37.6 | 1.9 | | | |
| Day-to-Day | Mean (ng/mL) | CV% | Conc. (ng/mL) | Mean (ng/mL) | CV% |
| 12.5 ng/mL | 12.4 | 8.6 | 12.5 | 12 | 10 |
| 18.75 ng/mL | 16.2 | 6.6 | 18.75 | 19 | 5 |
| 25.0 ng/mL | 25.3 | 5.0 | 25.0 | 24 | 3 |
| 31.25 ng/mL | 29.7 | 4.0 | 31.25 | 27 | 3 |
| 37.5 ng/mL | 36.3 | 3.4 | | | |
| Accuracy | | | | | |
| 25 ng/mL Cutoff | N= 50 Confirmed Pos.<br>50 Pos. 0 Neg. | | N = 75 Confirmed Pos.<br>75 Pos. 0 Neg. | | |
| | N= 14 diluted within 25%<br>above cutoff concentration<br>14 Pos. 0 Neg. | | | | |
| | N= 14 diluted within 25%<br>below cutoff concentration<br>0 Pos. 14 Neg. | | | | |
| Limit of Detection | 0.6 ng/mL | | 6 ng/mL (clinical sensitivity) | | |

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Public Health Service

FEB 1 0 1999

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Rita Smith Senior Regulatory Affairs Associate Roche Diagnostic Systems, Inc. Branchburg Township 1080 U.S. Highway 202 Somerville, New Jersey 08876-3771

Re: K983704 Trade Name: Abuscreen ONLINE Phencyclidine Regulatory Class: II Product Code: JCM Dated: January 14, 1999 Received: January 19, 1999

Dear Ms. Smith:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition. FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

Image /page/6/Picture/9 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines beneath them.

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### Page 2

Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled. "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours.

Steven Autman

Steven I. Gutman, M.D, M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of of 1

510(k) Number (if known)

Device Name: Abuscreen ONLINE® Phencyclidine

Indications for Use:

Abuscreen ONLINE for Phencyclidine is an in vitro diagnostic test for the qualitative and semiquantitative detection of phencyclidine and its metabolites in human urine on the Hitachi 917 analyzer at a cutoff concentration of 25 ng/mL. Semiquantitative test results may be obtained that permit laboratories to assess assay performance as part of a quality control program. Measurements obtained by this device are used in the diagnosis of phencyclidine use or abuse.

Jean Cooper

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K983704

## (PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Prescription Use

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use (Optional Format 1-2-96)