(23 days)
Not Found
No
The device description and intended use clearly indicate a quality control material for laboratory testing, with no mention of AI or ML technologies. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No
The device is a quality control urine used to monitor the performance of laboratory urine toxicology screening procedures, not to treat a medical condition.
No
The device is a quality control urine used to monitor the performance of laboratory urine toxicology screening procedures, not to diagnose a patient.
No
The device description clearly states it is a liquid control material prepared from human urine with added substances, indicating it is a physical product, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for "monitoring the performance of laboratory urine toxicology screening procedures." This means it's used in vitro (outside the body) to assess the accuracy and reliability of a diagnostic test.
- Device Description: It's a "quality control urine" prepared from human urine with added substances. This material is used to evaluate the performance of a diagnostic assay.
- Care Setting: It's intended for use in a "laboratory," which is a typical setting for IVD testing.
The core function of this device is to serve as a control for an in vitro diagnostic test (urine toxicology screening). This directly aligns with the definition of an IVD.
N/A
Intended Use / Indications for Use
Liquichek Urine Toxicology Control is intended for use as a quality control urine to monitor the performance of laboratory urine toxicology screening procedures.
Product codes (comma separated list FDA assigned to the subject device)
91DIF
Device Description
Liquichek Urine Toxicology Control is prepared from human urine with added drugs, drug metabolites, preservatives and stabilizers. The control is provided in liquid form for convenience. This product contains 0.1% sodium azide as a preservative.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
laboratory
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
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Image /page/0/Picture/1 description: The image shows the logo for BIO-RAD. The logo is white text on a black rounded rectangle. The text is in all caps and bolded.
Bio-Rad
Laboratories
ECS Division 3726 E. Miraloma Avenue naheim. CA 92806 Telephone (714) 630-6400 Toll Free (800) 854-6737
510(k) Summary
MAY 30 1997
Submitter Bio-Rad Laboratories, ECS Division 3726 E. Miraloma Avenue Anaheim, CA 92806 (714)630-6400 Fax (714)666-1383
Contact Person Elizabeth Platt
Date of Summary Preparation February 7, 1997
Device (Trade & Common Name) Liquichek Urine Toxicology Control
Classification Name Class I, CFR 862.3280: Drug Mixture Control 91DIF
Devices to Which Substantial Equivalence is Claimed Liguid Drugs of Abuse Controls Medical Analysis Systems, Camarillo, California K903430
Statement of Intended Use
Liquichek Urine Toxicology Control is intended for use as a quality control urine to monitor the performance of laboratory urine toxicology screening procedures.
1
Image /page/1/Picture/0 description: The image shows the logo for Bio-Rad. The logo is in white text on a black background. The text is bold and sans-serif.
ratories
ECS Division 3726 E. Miraloma Avenue Anaheim. CA 92806 Telephone (714) 630-6400 Toll Free (800) 854-6737
Description of the Device
Liquichek Urine Toxicology Control is prepared from human urine with added drugs, drug metabolites, preservatives and stabilizers. The control is provided in liquid form for convenience.
This product contains 0.1% sodium azide as a preservative.
Statement of How Technological Characteristics Compare to Substantial Equivalence Device
A table is provided below comparing the similarities between the Bio-Rad Liquichek Urine Toxicology Control and the devices to which substantial equivalence is claimed.
| | Bio-Rad Liquichek
Urine Toxicology Control | Liquid Drugs of Abuse Controls
Medical Analysis Systems |
|-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended
Use | A quality control urine to monitor
the performance of laboratory
urine toxicology screening
procedures. | A consistent test sample of known
concentration for monitoring assay
conditions in quantitative and
qualitative analysis of patient urine
specimens for drug and drug
metabolites. |
| Levels | Level S1 = Drugs added at
concentrations
20-25% below
immunoassay cutoff
Level S2 = Drugs added at
concentrations
20-25% above
immunoassay cutoff
Level S3 = Elevated
immunoassay | Level 2 = 20-25% below
immunoassay cutoff
Level 3 = 20-25% above
immunoassay cutoff
Level 4 = Elevated
immunoassay |
| Form | Liquid | Liquid |
| Matrix | Human Urine | Human Urine |
| Storage | 2-8°C | 2-8°C |
| Open
Vial
Claim | 30 Days at 2-8°C | 30 Days at 2-8°C |
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
MAY 30 1997
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Elizabeth Platt Staff Regulatory Affairs Representative Bio-Rad Laboratories ... . ..... 3726 E. Miraloma Avenue Anaheim, California 92806
Re: K971691 Liquichek Urine Toxicology Control - Level S1, S2, S3 Requlatory Class: I Product Code: DIF Dated: April 16, 1997 Received: May 7, 1997
Dear Ms. Platt:
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 The general controls provisions of the Act 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 Requlations, Title 21, Parts 800 to 895. ਕ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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.
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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 (770) 488-7655.
This letter will allow you to begin marketing your device as w 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 (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Steven Litman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
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Page 1 of 1
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:
510(k) Number: Device Name: Liquichek Urine Toxicology Control
Indications for Use:
12 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1
Liquichek Urine Toxicology Control is intended for use as a quality control urine Liquichek Unite Toxicology Oonliror in interactive concology screening procedures.
to monitor the performance of laboratory urine toxicology screening procedures.
(PLEASE DO NOT WRITE BELOW THE LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
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510(k) Number