(23 days)
Liquichek Urine Toxicology Control is intended for use as a quality control urine to monitor the performance of laboratory urine toxicology screening procedures.
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.
The provided text details a 510(k) summary for the Bio-Rad Liquichek Urine Toxicology Control, primarily focusing on establishing substantial equivalence to a predicate device. This type of submission, particularly from 1997, predates the extensive and detailed performance study requirements often seen in more recent AI/ML device submissions.
Therefore, the document does not contain the acceptance criteria and a study proving the device meets those criteria in the way you've outlined for AI/ML devices.
Here's why and what information can be extracted:
1. A table of acceptance criteria and the reported device performance:
- No explicit acceptance criteria or reported performance metrics are provided. The document focuses on comparing the technological characteristics of the new device to a predicate device to establish substantial equivalence. This is a comparison of features and intended use, not a performance evaluation against specific criteria.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified for performance metrics | Not specified for performance metrics |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Not applicable / Not provided. The document describes a "control" product for monitoring other diagnostic tests. It isn't a diagnostic device itself that processes a "test set" of patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- Not applicable / Not provided. As it's a quality control product, the concept of "ground truth" for patient data or expert interpretation doesn't apply to the device's own performance evaluation as described. The "truth" for this device is its known concentration of drugs.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable / Not provided.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable / Not provided. This is a quality control product, not an AI/ML-powered diagnostic tool involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable / Not provided. Not an algorithm-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the control itself, the "ground truth" is inherent to its manufacture: known concentrations of drugs and drug metabolites added to human urine. The document states it is "prepared from human urine with added drugs, drug metabolites, preservatives and stabilizers."
8. The sample size for the training set:
- Not applicable / Not provided. This is not an AI/ML device requiring a training set.
9. How the ground truth for the training set was established:
- Not applicable / Not provided.
Summary of Relevant Information from the Document:
The provided document is a 510(k) summary for a quality control product, not a diagnostic device that processes patient data or uses AI/ML. Its purpose is to monitor the performance of other laboratory urine toxicology screening procedures.
The "study" presented is a comparison of technological characteristics to a legally marketed predicate device (K903430 - Liquid Drugs of Abuse Controls Medical Analysis Systems) to demonstrate substantial equivalence, rather than a performance study with acceptance criteria against patient samples.
Key comparisons for substantial equivalence:
- Intended Use: Both are quality control urine to monitor the performance of laboratory urine toxicology screening procedures.
- Levels: Both have similar concepts for drug concentrations relative to immunoassay cutoffs (e.g., 20-25% below, 20-25% above, elevated).
- Form: Liquid
- Matrix: Human Urine
- Storage: 2-8°C
- Open Vial Claim: 30 Days at 2-8°C
The FDA's letter (K971691) confirms the finding of substantial equivalence based on this comparison.
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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.
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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 LiquichekUrine Toxicology Control | Liquid Drugs of Abuse ControlsMedical Analysis Systems | |
|---|---|---|
| IntendedUse | A quality control urine to monitorthe performance of laboratoryurine toxicology screeningprocedures. | A consistent test sample of knownconcentration for monitoring assayconditions in quantitative andqualitative analysis of patient urinespecimens for drug and drugmetabolites. |
| Levels | Level S1 = Drugs added atconcentrations20-25% belowimmunoassay cutoffLevel S2 = Drugs added atconcentrations20-25% aboveimmunoassay cutoffLevel S3 = Elevatedimmunoassay | Level 2 = 20-25% belowimmunoassay cutoffLevel 3 = 20-25% aboveimmunoassay cutoffLevel 4 = Elevatedimmunoassay |
| Form | Liquid | Liquid |
| Matrix | Human Urine | Human Urine |
| Storage | 2-8°C | 2-8°C |
| OpenVialClaim | 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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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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510(k) Number: Device Name: Liquichek Urine Toxicology Control
Indications for Use:
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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
§ 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.