(30 days)
Liquichek™ Urine Chemistry Control is intended for use as an assayed quality control urine to monitor the precision of laboratory procedures listed in the package insert.
Liquichek™ Urine Chemistry Control is prepared from human urine with added constituents of human and animal origin, pure chemicals, preservatives and stabilizers. The control is provided in liquid form for convenience.
The provided document is a 510(k) Premarket Notification for a Liquichek™ Urine Chemistry Control device, which is a quality control material. This type of device is used to monitor the precision of laboratory testing procedures for various analytes in urine.
The request asks for information typically associated with clinical studies of diagnostic or screening devices (e.g., sample size, expert ground truth, MRMC studies, standalone performance). However, since the Liquichek™ Urine Chemistry Control is a quality control material and not a diagnostic or screening device itself, the traditional metrics and study types for determining diagnostic performance (like sensitivity, specificity, or reader improvement with AI assistance) are not applicable.
Instead, the "acceptance criteria" for a quality control material typically relate to its stability, accuracy of assigned values, and its ability to consistently perform within expected ranges over its shelf life and open-vial period. The "study that proves the device meets the acceptance criteria" would therefore be stability studies and verification of manufacturing quality.
Based on the provided text, here's a breakdown of the requested information, adapted for a quality control device:
1. A table of acceptance criteria and the reported device performance
For a quality control material, acceptance criteria are generally related to its stability and the accurate assignment of analyte values. The document focuses on stability.
| Acceptance Criteria Category | Specific Criteria (Implicit/Stated) | Reported Device Performance |
|---|---|---|
| Open Vial Stability | All analytes stable within acceptable limits after opening. | 30 days when stored tightly capped at 2-8°C. |
| Shelf Life | All analytes stable within acceptable limits until expiration date. | One year and six months when stored at 2-8°C. |
| Analyte Content | Contains specified analytes as defined in the product specification. | Includes Cortisol in addition to other analytes (Table 1). |
| Matrix | Human urine based. | Human urine based. |
| Form | Liquid. | Liquid. |
| Storage (Unopened) | 2 to 8°C. | 2 to 8°C. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document states: "Stability studies have been performed..." and "Real time studies will be ongoing to support the shelf life of this product."
- Sample Size (Test Set): The document does not specify the sample size (e.g., number of vials, batches) used for the stability studies.
- Data Provenance: The studies were conducted by Bio-Rad Laboratories, located in Irvine, California, USA. The studies supporting initial claims are likely prospective (real-time stability), with "ongoing" real-time studies for shelf life.
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)
For a quality control material, "ground truth" refers to the assigned values for each analyte. This is typically established through a rigorous process of testing using reference methods and/or multiple calibrated instruments in an accredited laboratory, often involving a consensus of results. The document does not specify the number or qualifications of experts involved in establishing these assigned values. This process is generally part of the manufacturer's quality system and product development, rather than a clinical expert panel.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods like 2+1 are used in clinical studies for interpretation of images or clinical events, often when ground truth is subjective or requires expert consensus. For a quality control material, the "ground truth" (assigned values) are determined analytically and through statistical analysis of multiple measurements, not through expert adjudication in this sense.
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. MRMC studies are designed for diagnostic or screening devices where human readers interpret patient data (e.g., medical images). This device is a quality control material, not a diagnostic tool for patient cases, and does not involve human "readers" in the context of diagnostic interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical reagent, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For a quality control material, the "ground truth" is typically the assigned value for each analyte. These values are established by the manufacturer through a comprehensive assay process (using highly calibrated instruments and reference methods) and statistical determination, often referred to as "value assignment." It is not based on expert consensus for clinical diagnosis, pathology, or outcomes data, but rather on analytical accuracy and precision.
8. The sample size for the training set
Not applicable. This device does not use machine learning or algorithms that require a "training set." The performance is based on the inherent chemical and physical stability of the material, verified through laboratory studies.
9. How the ground truth for the training set was established
Not applicable. As there is no training set for an algorithm, there is no "ground truth for the training set" to establish in this context.
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APR 1 2 2002
Page 1 of 2
Bio-Rad Laboratories Premarket Notification Section 510(k) for Liquichek™ Urine Chemistry Control Summary of Safety and Effectiveness
Summary of Safety and Effectiveness Liquichek™ Urine Chemistry Control
1.0 Submitter
Bio-Rad Laboratories 9500 Jeronimo Road, Irvine, California 92618-2017 Telephone: (949) 598-1200 (949) 598-1555 Fax:
Contact Person
Maria Zeballos Regulatory Affairs Specialist Telephone: (949) 598-1367
Date of Summary Preparation
March 11. 2002
2.0 Device Identification
| Product Trade Name: | Liquichek™ Urine Chemistry Control |
|---|---|
| Common Name: | Multi-Analyte Controls, (Assayed and unassayed) |
| Classifications: | Class I |
| Product Code: | JJY |
| Regulation Number: | 21 CFR 862.1660 |
3.0 Device to Which Substantial Equivalence is Claimed
Liquichek™ Urine Chemistry Control Bio-Rad Laboratories Irvine, California
Docket Number: K971954
4.0 Description of Device
Liquichek™ Urine Chemistry Control is prepared from human urine with added constituents of human and animal origin, pure chemicals, preservatives and stabilizers. The control is provided in liquid form for convenience.
5.0 Statement of Intended Use
Liguichek™ Urine Chemistry Control is intended for use as an assayed quality control urine to monitor the precision of laboratory procedures listed in the package insert.
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Comparison of the new device with the Predicate Device 6.0
Liquichek™ Urine Chemistry Control claims substantial equivalence to the Liquichek™ Urine Chemistry Control levels currently in commercial distribution (K971954). The new Liquichek™ Urine Chemistry Control contains Cortisol and the current product does not.
| Characteristics | Bio-RadLiquichek™ Urine Chemistry Control(New Device) | Bio-RadLiquichek™ Urine Chemistry Control(Predicate Device) |
|---|---|---|
| Similarities | ||
| Intended Use | Liquichek™ Urine Chemistry Control isintended for use as assayed quality controlurine to monitor the precision of laboratorytesting procedures for analytes listed in thepackage insert. | Liquichek™ Urine Chemistry Control isintended for use as assayed quality controlurine to monitor the precision of laboratorytesting procedures for analytes listed in thepackage insert. |
| Form | Liquid | Liquid |
| Matrix | Human urine based | Human urine based |
| Storage(Unopened) | 2 to 8°CUntil expiration date | 2 to 8°CUntil expiration date |
| Open Vial Claim | 30 days at 2-8°C | 30 days at 2-8°C |
| Differences | ||
| Analytes | Contains: Amylase, Calcium, Chloride,Cortisol, Creatinine, Glucose, Magnesium,Microalbumin, Osmolality, pH, Phosphorus,Potassium, Pregnancy, Protein- Total,Sodium, Specific Gravity, Urea, UreaNitrogen, Uric Acid. | Contains: Amylase, Calcium, Chloride,Creatinine, Glucose, Magnesium,Microalbumin, Osmolality, pH, Phosphorus,Potassium, Pregnancy, Protein- Total,Sodium, Specific Gravity, Urea, UreaNitrogen, Uric Acid.Does not Contain: Cortisol |
Table 1. Similarities and Differences between new and predicate device.
7.0 Summary of Performance Data
Stability studies have been performed to determine the open vial stability and shelf life for the Liquichek™ Urine Chemistry Control. Product claims are as follows:
- Open vial: Once the control material is opened, all analytes will be stable for 30 7.1 days when stored tightly capped at 2-8°C.
- Shelf Life: One year and six months when stored at 2-8 ℃. 7.2
Real time studies will be ongoing to support the shelf life of this product. All supporting data is retained on file at Bio-Rad Laboratories.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular fashion around the symbol. The text is in all caps and is evenly spaced around the circle.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Elizabeth Platt Regulatory Affairs/Quality Assurance Manager Bio-Rad Laboratories, QSD 9500 Jeronimo Road Irvine, CA 92618-2017
APR 1 2 2002
Re: K020817
Trade/Device Name: Liquichek™ Urine Chemistry Control Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I reserved Product Code: JJY Dated: March 11, 2002 Received: March 13, 2002
Dear Ms. Platt:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - -
This letter will allow you to begin marketing your device as 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 1 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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer Assistance at its toll-free number (800) 638-2041 or 11analatotal 610 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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510 (k) Number (if known):____________________________________________________________________________________________________________________________________________________
Device Name: Liquichek™ Urine Chemistry Control
Indications for Use:
Liquichek™ Urine Chemistry Control is intended as an assayed quality control urine to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.
Sean Conroy
Division Sign-Off) Division of Clinical Laboratory Devices 120817 510(k) Number --
(PLEASE DO NOT WRITE BELOW THE LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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.