(14 days)
Liquichek Urine Chemistry Control is intended for use as an assayed quality control urine to monitor the precision of laboratory testing procedures for the analytes listed in this package insert.
Liquichek Urine Chemistry Control is prepared from human urine with added constituents of human and non-human origin and pure chemicals. The control is provided in liquid form for convenience. This product contains <0.1% sodium azide as a preservative.
This is a 510(k) premarket notification for a quality control material, not a medical device in the typical sense that would involve a study with human patients, performance metrics like sensitivity/specificity, or expert review. Therefore, many of the requested categories (like sample size for test set, number of experts, adjudication method, MRMC studies, standalone performance, and ground truth for training) are not applicable.
The submission focuses on establishing substantial equivalence to a legally marketed predicate device (Quantimetrix Corporation Human Urine Control) based on similar technological characteristics and intended use. The "acceptance criteria" here refer to meeting the requirements for substantial equivalence.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Criteria | Bio-Rad Liquichek Urine Chemistry Control (Reported Performance) | Predicate Device (Quantimetrix Human Urine Control) |
|---|---|---|
| Intended Use | An assayed quality control urine to monitor the precision of laboratory testing procedures for the analytes listed in the package insert. | A means for monitoring human urine assay methods to validate quantitation of patient samples. |
| Levels | Two | Two |
| Form | Liquid | Liquid |
| Open Vial Claim | 30 Days at 2-8°C | 24 Months at 2-8°C |
| Matrix | Human Urine | Human Urine |
| Storage | 2-8°C | 2-8°C |
Study Proving Acceptance Criteria:
The "study" proving the device meets acceptance criteria is primarily a comparison of technological characteristics and intended use against a legally marketed predicate device, as presented in the table above and the overall 510(k) submission. The FDA reviewed this comparison and deemed the device "substantially equivalent."
Specific Responses to Your Questions:
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Sample size used for the test set and the data provenance: Not applicable. This is a quality control material, not a diagnostic device tested on patient samples in the typical sense. The "test set" would implicitly refer to the characteristics of the control material itself, which were presumably validated internally by Bio-Rad to meet specifications, but these internal validation details are not provided in the 510(k) summary. The document does not describe patient data or clinical studies.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically understood for diagnostic device performance (e.g., presence/absence of disease) is not relevant for a quality control material.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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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. This device is a quality control material, not an AI-powered diagnostic tool for human readers.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a material, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the context of clinical outcomes or disease. For quality control materials, "ground truth" would refer to the assigned values and stability of the analytes within the control, which are established through internal validation processes by the manufacturer. These specific data are not detailed in the 510(k) summary.
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The sample size for the training set: Not applicable. No "training set" in the context of machine learning or algorithm development is mentioned or relevant for this type of product.
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How the ground truth for the training set was established: Not applicable.
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Image /page/0/Picture/1 description: The image shows the logo for Bio-Rad Laboratories, a company that develops, manufactures, and markets a broad range of products and services to the life science research and clinical diagnostics markets. The logo is white text on a black background. The text is in a bold, sans-serif font.
Bio-Rad
Laboratories
m. CA 9. hone (714) 630
June 11, 1997
510(k) Summary
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 May 23, 1997
Device (Trade & Common Name) Liquichek Urine Chemistry Control
Classification Name Class I. 75JJY CFR 862.1660: Quality Control Material (Assayed and Unassayed)
Devices to Which Substantial Equivalence is Claimed Human Urine Control Quantimetrix Corporation Redondo Beach, CA
Statement of Intended Use
Liquichek Urine Chemistry Control is intended for use as an assayed quality control urine to monitor the precision of laboratory testing procedures for the analytes listed in this package insert.
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Image /page/1/Picture/0 description: The image shows the logo for Bio-Rad. The text "BIO-RAD" is written in white, bold, sans-serif letters. The text is set against a black, rounded rectangle.
Bio-Rad
Laboratories
ECS Division 3726 E. Miraloma Avenue naheim, CA 92806 Telephone (714) 630-6400 Toll Free (800) 854-6737
Description of the Device
Liquichek Urine Chemistry Control is prepared from human urine with added constituents of human and non-human origin and pure chemicals. 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 Chemistry Control and the devices to which substantial equivalence is claimed.
| Bio-Rad LaboratoriesLiquichek Urine Chemistry Control | Quantimetrix CorporationHuman Urine Control | |
|---|---|---|
| IntendedUse | an assayed quality control urineto monitor the precision oflaboratory testing procedures forthe analytes listed in thispackage insert. | a means for monitoring humanurine assay methods to validatequantitation of patient samples. |
| Levels | Two | Two |
| Form | Liquid | Liquid |
| OpenVialClaim | 30 Days at 2-8°C | 24 Months at 2-8°C |
| Matrix | Human Urine | Human Urine |
| Storage | 2-8°C | 2-8°C |
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol is a stylized representation of a human figure, with three wavy lines forming the body and head. The logo is black and white.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUN 11 1997
Elizabeth Platt Staff Regulatory Affairs Representative Bio-Rad Laboratories 3726 E. Miraloma Avenue Anaheim, California 92806
Re : K971954 Liquichek Urine Chemistry Control Requlatory Class: I Product Code: JJY May 23, 1997 Dated: Received: May 28, 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 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. ਰ 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 CMP 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 described in your 510(k) premarket notification. The FDA findinq 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 requlation (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 Gutman
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 1 of 1
510(k) Number: Device Name: Liquichek Urine Chemistry Control 参
Indications for Use:
Liquichek Urine Chemistry Control is intended for use as an assayed quality control urine to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.
(PLEASE DO NOT WRITE BELOW THE LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
(Concurrence of CDRH, Office of Device Evaluation)
(Division Sign-Off)
Division of Clinical Laboratory Devices
| 510(k) Number | 8971954 |
|---|---|
| --------------- | --------- |
| Prescription Use | OR | Over-The Counter Use | ||
|---|---|---|---|---|
| ------------------ | -- | ---- | ---------------------- | -- |
§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.