ONLINE DAT PHENCYCLIDINE PLUS

K043305 · Roche Diagnostics Corp. · LCM · Jan 10, 2005 · TX

Device Facts

• Record ID: K043305
• Device Name: ONLINE DAT PHENCYCLIDINE PLUS
• Applicant: Roche Diagnostics Corp.
• Product Code: LCM · TX
• Decision Date: Jan 10, 2005
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U

Intended Use

The Phencyclidine Plus is an in vitro diagnostic test for the qualitative and semi-quantitative detection of phencyclidine and its metabolites in human urine on automated clinical chemistry analyzers at a cutoff of 25 ng/ml. Semi-quantitative test results may be obtained that permit laboratories to assess assay performance as part of a quality control program. Phencyclidine Plus provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GS/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

Device Story

ONLINE DAT Phencyclidine Plus is an in vitro diagnostic reagent system for automated clinical chemistry analyzers. It detects phencyclidine in human urine using Kinetic Interaction of Microparticles in Solution (KIMS) technology. Principle: drug-conjugated microparticles and monoclonal antibodies form aggregates, increasing light absorbance; presence of phencyclidine in sample competes for antibody, inhibiting aggregation and reducing absorbance. Output: qualitative or semi-quantitative concentration relative to 25 ng/mL cutoff. Used in clinical laboratories by technicians/pathologists to screen for drug use. Results are preliminary; require confirmation via GC/MS. Benefits: rapid screening for phencyclidine exposure.

Clinical Evidence

No clinical data provided. Bench testing only.

Technological Characteristics

KIMS (Kinetic Interaction of Microparticles in Solution) technology. Reagents include drug-conjugated microparticles and mouse monoclonal antibodies. Automated clinical chemistry analyzer platform. Qualitative/semi-quantitative detection at 25 ng/mL cutoff.

Indications for Use

Indicated for qualitative and semi-quantitative detection of phencyclidine and metabolites in human urine for clinical laboratory use. Provides preliminary analytical results requiring confirmation by alternate methods (e.g., GC/MS).

Predicate Devices

• Abuscreen OnLine Phencyclidine assay (K983704)

Submission Summary (Full Text)

{0}------------------------------------------------

K043305

# JAN 1 0 2005

| Introduction | According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence. |
|-------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1) Submitter name, address, contact | Roche Diagnostics<br>9115 Hague Rd.<br>Indianapolis, IN 46250<br>[phone] |
| | Contact Person: Dimitris Demirtzoglou |
| | Date Prepared: November 29, 2004 |
| 2) Device name | Proprietary name: ONLINE DAT Phencyclidine Plus |
| | Common name: Phencyclidine test system |
| | Classification name: Enzyme immunoassay, Phencyclidine |
| 3) Predicate device | We claim substantial equivalence to the currently marketed Abuscreen OnLine Phencyclidine assay (K983704). |

Continued on next page## 510(k) Summary

{1}------------------------------------------------

### 510(k) Summary, Continued

The Roche ONLINE DAT Phencyclidine Plus reagent is an in vitro 4) Device The Rooms OF(Er. the qualitative and semi-quantitative detection of Description Glaghostic Test - 101 - the -qualifical chemistry analyzers at a phoff of 25 ng/m1. Semi-quantitative test results may be obtained that permit laboratories to assess assay performance as part of a quality control program.

#### Principal of procedure

The ONLINE DAT Phencyclidine Plus assay is based on the kinetic interaction of microparticles in a solution (KIMS technology). Assay measurement is based on measurable changes in light transmission related to the interaction of microparticles in a solution and the sample drug of interest, if present. Phencyclidine drug derivative is conjugated to microparticles in If present. I noneyondine arag noclonal antibody (mouse) is solubilized in In the absence of sample drug, free antibody binds to drugbuffer. microparticle conjugates causing the formation of particle aggregates. As the aggregation reaction proceeds in the absence of sample drug, the absorbance increases.

When a urine sample contains the drug in question, this drug competes with the particle-bound drug derivative for free antibody. Antibody bound to the particle bound drug convailable to promote particle aggregation, and subsequent particle lattice formation is inhibited. The presence of sample Subsoquein partiers the increasing absorbance in proportion to the concentration of drug in the sample. Sample drug content is determined relative to the value obtained for a known cutoff concentration of drug.

#### Negative Sample

drug-conjugated microparticles + free antibody = particle aggregates (↑ absorbance)

#### Positive Sample

sample drug + drug-conjugated microparticle = particle aggregation inhibited drug-conjugated microparticles + free antibody = particle aggregates

Continued on next page

{2}------------------------------------------------

## 510(k) Summary, Continued

-

| 5.) Intended<br>Use | The Phencyclidine Plus is an in vitro diagnostic test for the qualitative and<br>semi-quantitative detection of phencyclidine and its metabolites in human<br>urine on automated clinical chemistry analyzers at a cutoff of 25 ng/ml.<br>Semi-quantitative test results may be obtained that permit laboratories to<br>assess assay performance as part of a quality control program. |
|----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 6.) Comparison<br>to the Predicate<br>Device | The Roche ONLINE DAT Phencyclidine Plus is substantially equivalent to<br>other products in commercial distribution intended for similar use. Most<br>notably, it is substantially equivalent to the currently marketed Roche<br>Abuscreen OnLine Phencyclidine (K983704).<br><br>Both the new and predicate device assays are based on the kinetic interaction<br>of microparticles in a solution (KIMS technology). Differences between this<br>application and the predicate cleared assay include:<br>a change in the accelerant / activator contained in the diluent<br>solution used to make the antibody working solution (R1 reagent),<br>and use of new (previously cleared) calibrators and unassayed<br>controls. |

:

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The caduceus is depicted with three wavy lines, and the text is in all capital letters.

JAN 1 0 2005

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Dimitris Demirtzoglou Regulatory Affairs Consultant Roche Diagnostics 9115 Hague Road, P.O. Box 50457 Indianapolis, IN 46250-0457

Re: k043305

> Trade/Device Name: ONLINE DAT Phencyclidine Plus Regulation Number: 21 CFR 862.3100 Regulation Name: Amphetamine Test Systeme Regulatory Class: Class II Product Code: LCM Dated: November 20, 2004 Received: November 30, 2004

Dear Mr. Demirtzoglou:

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).

{4}------------------------------------------------

#### Page 2 -

This letter will allow you to begin marketing your device as described in your Section 510(k) I ms letter will and in your to ough finding of substantial equivalence of your device to a legally promation and in the 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 [phone]. 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 I va inay of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely yours,

Carelia B. Rooks

Cornelia B. Rooks, MA Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

## Indications for Use

510(k) Number: K043305

Device Name: ONLINE DAT Phencyclidine Plus

Indications For Use:

The Phencyclidine Plus is an in vitro diagnostic test for the qualitative and semi-quantitative detection of phencyclidine and its metabolites in human urine on automated clinical chemistry analyzers at a cutoff of 25 ng/ml. Semi-quantitative test results may be obtained that permit laboratories to assess assay performance as part of a quality control program. Phencyclidine Plus provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GS/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

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
acting

Office of In Vitro Diagnostic Device Evaluation and S

510(k) K043305