(30 days)
Clinical Controls LiquiSPx™ Liquid Saliva/Urine Drugs of Abuse Control is a ready-to-use, assayed chemistry control materials for monitoring the accuracy and precision of available analytical procedures. Drug analysis consisting of measuring amphetamine, methamphetamine, phencyclidine, cocaine, tetrahydrocanabinol and morphine is used to assist in the detection and management of drug abuse in at risk patient populations.
Liquid Saliva/Urine Drugs of Abuse Control
I am sorry but this document does not contain the information requested. This document is a 510k clearance letter from the FDA to Clinical Controls for their Liquid Saliva/Urine Drugs of Abuse Control device. It confirms that the device is substantially equivalent to previously marketed devices and can be legally marketed.
The document does not provide any details about:
- Acceptance criteria for device performance.
- The study that proves the device meets acceptance criteria.
- Sample sizes, data provenance, expert qualifications, or adjudication methods for any studies.
- Information on MRMC studies, standalone performance, or ground truth types.
- Details about training sets or how their ground truth was established.
Therefore, I cannot fulfill your request based on the provided 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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of human services, with three wave-like shapes emanating from a central point.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
SEP 2 8 2001
Mr. James F. Godfrey Official Correspondent, Regulatory Affairs Clinical Controls 12038 Centralia Road Suite C Hawaiian Gardens, CA 90716
K012907 Re:
K012707
Trade/Device Name: Liquid Saliva/Urine Drugs of Abuse Control Regulation Number: 21 CFR 862.3280 Regulation Name: Clinical Toxicology Control Material Regulatory Class: I, reserved Product Code: DIF Dated: August 25, 2001 Received: August 29, 2001
Dear Mr. Godfrey:
We have reviewed your Section 510(k) notification of intent to market the device referenced we nave reviewed your boomer be device is substantially equivalent to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Interstate commerco prior to has 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 I cocial I ood, Drug, and Soons of the Act. The general controls provisions of the Act include the general controls provincial of also interes, 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 (I ichiance ripptoval), it may or subject of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through r racclic GMP inspections, the Food and Drug Administration (FDA) will verify such periours. 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 addition, Please note: this response to your premarket notification submission does not affect 10 the reason wight 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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This letter will allow you to begin marketing your device as described in your 510(k) premarket I his fotor will and 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 (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, (Jease contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small mornation on 90 700 reading and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrb/dsma/dsmamain.html".
Sincerely yours,
Steven Butman
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_ | of_
| 510(k) Number (if known): | K012907 |
|---|---|
| --------------------------- | --------- |
Laud Device Name:_LIquiSPx
Saliva Urine Drugs of Abuse Control
Indications For Use:
Clinical Controls LiquiSPx™ Liquid Saliva/Urine Drugs of Abuse Control is a ready-tolight and the control and also tarials for monitoring the accuracy and precision of Clinical Controls Liquild Salival University of I aaco eavy and precision of
use, assayed chemistry control materials for montoring the accuracy and procision of
ections of t use, assayed chemistry control materials for monitoring the avoilable for the formated analytical procedures.
Drug analysis consisting of measuring amphetamine, methamphetamine, Drug analysis consisting of measuning and morphine is used to assist in the
phencyclidine, cocaine, tetrahydrocanabinol and morphine is used to assist in the phencyclidine, cocaine, tetranydrocanability and more in at risk patient populations.
detection and management of drug abuse in at risk patient populations.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Kesia Alvander Jr. Sean Cooper
(Division Sign-Off)
oratory Devices vision of Clinical La 510(k) Number.
Prescription Use_ (Pcr 21 CFR 801.109) OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
§ 862.3280 Clinical toxicology control material.
(a)
Identification. A clinical toxicology control material is a device intended to provide an estimation of the precision of a device test system and to detect and monitor systematic deviations from accuracy resulting from reagent or instrument defects. This generic type of device includes various single, and multi-analyte control materials.(b)
Classification. Class I (general 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.