ONE STEP MORPHINE CARD TEST

K970579 · Teco Diagnostics · DNK · Jul 3, 1997 · Clinical Toxicology

Device Facts

• Record ID: K970579
• Device Name: ONE STEP MORPHINE CARD TEST
• Applicant: Teco Diagnostics
• Product Code: DNK · Clinical Toxicology
• Decision Date: Jul 3, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3640
• Device Class: Class 2

Intended Use

A rapid, competitive binding immunoassay for qualitative determination of morphine in urine.

Device Story

One Step Morphine Card Test is a rapid, competitive binding immunoassay for qualitative morphine detection in urine. Device utilizes lateral flow technology; sample applied to test card; morphine in urine competes with drug conjugate for binding sites on antibody-coated particles. Visual readout provided by presence or absence of colored lines. Used in clinical laboratory settings by trained personnel to assist in drug screening. Results provide preliminary analytical test result; clinical consideration and professional judgment required for interpretation.

Clinical Evidence

No clinical data provided in the document; substantial equivalence based on technological characteristics and intended use.

Technological Characteristics

Lateral flow immunoassay; competitive binding principle; qualitative visual readout; urine specimen matrix.

Indications for Use

Indicated for the qualitative detection of morphine in human urine. Intended for prescription use in clinical laboratory settings.

Regulatory Classification

Identification

A morphine test system is a device intended to measure morphine, an addictive narcotic pain-relieving drug, and its analogs in serum, urine, and gastric contents. Measurements obtained by this device are used in the diagnosis and treatment of morphine use or overdose and in monitoring levels of morphine and its analogs to ensure appropriate therapy.

Special Controls

*Classification.* Class II (special controls). A morphine test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. 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, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (*e.g.,* programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).

Submission Summary (Full Text)

{0}

DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
2098 Gaither Road
Rockville MD 20850

Andrew Reams
Official FDA Correspondent
Teco Diagnostics
4925 E. Hunter Avenue
Anaheim, California 92807

JUL 3 1997

Re: K970579
OneStep Morphine Card Test
Regulatory Class: II
Product Code: DNK
Dated: April 28, 1997
Received: May 2, 1997

Dear Mr. Reams:

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, 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 requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (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 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.

{1}

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/dsmamain.html".

Sincerely yours,

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

{2}

05/01/96 14:38 301 594 5941 CDRH ODE 5710019 002

Page: 1 of 1

510(k) Number (if known):

Device Name: One Step Morphine Card Test

Indications For Use:
A rapid, competitive binding immunoassay for qualitative determination of morphine in urine.

Patricia A. Bernhardt (for AWM)
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K970579

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K970579

Prescription Use ☑ (Per 21 CFR 801.109)
OR
Over-The-Counter Use ☐ (Optional Format 1-2-96)

TX II