← Product Code LCM · K060353

# ACRO RAPID PHENCYCLIDINE URINE TEST, CATALOG PCP001000 (K060353)

_Acro Biotech, LLC · LCM · May 3, 2006 · TX · SESE_

**Canonical URL:** https://fda.innolitics.com/device/K060353

## Device Facts

- **Applicant:** Acro Biotech, LLC
- **Product Code:** LCM
- **Decision Date:** May 3, 2006
- **Decision:** SESE
- **Submission Type:** Traditional
- **Device Class:** Class U
- **Review Panel:** TX

## Intended Use

Acro Rapid Phencyclidine Urine Test is a lateral flow, one-step immunoassay for the qualitative detection of Phencyclidine in human urine at a cutoff of 25 ng/mL. The test is used to obtain a visual qualitative result and is intended for central laboratory use only. This assay provides only a preliminary result. Clinical consideration and professional judgment must be applied to a drug test result, particularly in evaluating a preliminary positive result. In order to obtain a confirmed analytical result, a more specific alternate chemical is needed. Gas Chromatography/ Mass Spectroscopy (GC/MS) analysis is preferred.

## Device Story

Lateral flow, one-step immunoassay for qualitative detection of Phencyclidine in human urine. Device utilizes competitive binding principle; drug in urine competes with drug conjugate for limited antibody binding sites. Visual qualitative result produced on test strip. Intended for central laboratory use by trained personnel. Provides preliminary screening results; requires confirmation by more specific alternate chemical method, preferably GC/MS. Clinical judgment required for interpretation of preliminary positive results.

## Clinical Evidence

Bench testing only; no clinical data provided.

## Technological Characteristics

Lateral flow immunoassay; one-step format; visual qualitative readout; 25 ng/mL cutoff; human urine specimen; non-automated.

## Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the caduceus.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

#### 3 2006 MAY

Acro Biotech LLC. c/o Gregory Lee, Ph.D. 9500 7th Street, Unit M Rancho Cucamonga, CA 91730

Re: k060353

Trade/Device Name: Acro Rapid Phencyclidine Urine Test Regulatory Class: Class II Product Code: LCM Dated: February 13, 2006 Received: February 17, 2006

Dear Dr. Lee:

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).

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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 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

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# Indications for Use

## 510(K) NUMBER (IF KNOWN) k060353

Device Name: Acro Rapid Phencyclidine Urine Test

#### Indications for Use

Acro Rapid Phencyclidine Urine Test is a lateral flow, one-step immunoassay for the qualitative detection of Phencyclidine in human urine at a cutoff of 25 ng/mL. The test is used to obtain a visual qualitative result and is intended for central laboratory use only.

This assay provides only a preliminary result. Clinical consideration and professional judgment must be applied to a drug test result, particularly in evaluating a preliminary positive result. In order to obtain a confirmed analytical result, a more specific alternate chemical is needed. Gas Chromatography/ Mass Spectroscopy (GC/MS) analysis is preferred.

> Prescription Use x (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Division Sign-Off

Office of In Vitro Diagnostic Device
Evaluation and Safety

| 510(k) | k060353 |
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**Source:** [https://fda.innolitics.com/device/K060353](https://fda.innolitics.com/device/K060353)

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