50NG/ML COCAINE METABOLITE CALIBRATOR

K972835 · Diagnostic Reagents, Inc. · DLJ · Aug 28, 1997 · Clinical Toxicology

Device Facts

• Record ID: K972835
• Device Name: 50NG/ML COCAINE METABOLITE CALIBRATOR
• Applicant: Diagnostic Reagents, Inc.
• Product Code: DLJ · Clinical Toxicology
• Decision Date: Aug 28, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3200
• Device Class: Class 2

Intended Use

This 50 ng/mL cocaine metabolite urine calibrator is intended to be used for calibrating cocaine metabolite enzyme immunoassay for qualitative and semi-quantitative determination of cocaine and its metabolites in human urine. The assay results obtained with the cocaine metabolite enzyme immunoassay in combination with the use of such calibrator provide only a preliminary analytical result. A more specific alternate method must be used in order to obtain a confirmed analytical result. Gas chromatograph/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 preliminary positive results are used.

Device Story

Device is a 50 ng/mL cocaine metabolite urine calibrator; used in clinical laboratory settings to calibrate enzyme immunoassay systems for drug of abuse testing. Input is human urine sample; device provides reference standard for assay calibration. Output is a calibrated assay system capable of preliminary qualitative or semi-quantitative detection of cocaine metabolites. Healthcare providers use results to screen for drug presence; preliminary positive results require confirmation via GC/MS. Device aids in clinical decision-making by providing standardized reference points for immunoassay performance.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

In vitro diagnostic calibrator; liquid-based chemical standard for enzyme immunoassay calibration. No software, electronics, or complex mechanical components.

Indications for Use

Indicated for use as a calibrator for cocaine metabolite enzyme immunoassays to qualitatively or semi-quantitatively detect cocaine and its metabolites in human urine samples.

Regulatory Classification

Identification

A clinical toxicology calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. A clinical toxicology calibrator can be a mixture of drugs or a specific material for a particular drug (e.g., ethanol, lidocaine, etc.). (See also § 862.2 in this part.)

Special Controls

*Classification.* Class II (special controls). 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.

Submission Summary (Full Text)

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

AUG 28 1997

Yuh-geng Tsay, Ph.D. President Diagnostic Reagents, Inc. 601 California Avenue Sunnyvale, California 94086 - - ------

Re : K972835 50 ng/mL Cocaine Metabolite Urine Calibrator Trade Name: Requlatory Class: II Product Code: DLJ Dated: July 29, 1997 Received: July 31, 1997

Dear Dr. Tsay:

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 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, labelinq, and prohibitions aqainst 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 requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory 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.

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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 requlation (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 qeneral information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll free number [phone] or at [phone] or at its internet address "http://www.fda.gov/cdrh/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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510(k) Number (if known):

50 ng/mL COCAINE METABOLITE CALIBRATOR Device Name: .......

Indications For Use:

This 50 ng/mL cocaine metabolite urine calibrator is intended to be used for calibrating cocaine : metabolite enzyme immunoassay for qualitative and semi-quantitative determination of cocaine and its metabolites in human urine.

The assay results obtained with the cocaine metabolite enzyme immunoassay in combination with the use of such calibrator provide only a preliminary analytical result. A more specific alternate method must be used in order to obtain a confirmed analytical result. Gas chromatograph/mass spectrometry (GC/MS) is the preferred Clinical consideration and professional judgment should be confirmatory method. applied to any drug of abuse test result, particularly when preliminary positive results are used.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

ision Sign-Off)

ivision of Clinical Laboratory vices

510(k) Numbe: K0972830

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)