(30 days)
Not Found
No
The 510(k) summary describes a chemistry control material for monitoring the accuracy and precision of drug analysis procedures. There is no mention of AI or ML in the intended use, device description, or any other section. The device is a control material, not an analytical device that would typically incorporate such technologies.
No
This device is a control material used for monitoring the accuracy and precision of analytical procedures, not for treating any medical condition.
No
Explanation: This device is a control material used for monitoring the accuracy and precision of analytical procedures for drug analysis. It does not diagnose.
No
The device description and intended use clearly indicate a physical, liquid control material for laboratory testing, not a software application.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for "monitoring the accuracy and precision of available analytical procedures" for drug analysis in saliva and urine. This is a classic function of an IVD control material.
- Device Description: It's described as a "Liquid Saliva/Urine Drugs of Abuse Control," which is a type of reagent used in laboratory testing.
- Anatomical Site: It uses "Saliva/Urine," which are biological specimens collected from the human body for in vitro testing.
- Intended User / Care Setting: It's intended for "Clinical Laboratory Devices," indicating it's used in a laboratory setting for diagnostic purposes.
- Predicate Device: The presence of a predicate device (K012707; Liquid Saliva/Urine Drugs of Abuse Control) further confirms its classification as an IVD, as predicate devices are typically other legally marketed IVDs.
All these factors align with the definition of an In Vitro Diagnostic device, which is a medical device intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to monitor therapeutic measures.
N/A
Intended Use / Indications for Use
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 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.
Product codes
DIF
Device Description
Liquid Saliva/Urine Drugs of Abuse Control
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Saliva, Urine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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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Page 2 -
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
2
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)