(61 days)
Liquichek Urinalysis Control is intended for use as an assayed quality control urine to monitor the precision of urinalysis test procedures for the analytes listed in this package insert.
Liquichek™ Urinalysis Control is prepared from human urine with added human erythrocytes, simulated leukocytes, constituents of animal origin, pure chemicals, preservatives and stabilizers. The control is provided in liquid form for convenience.
The provided text describes the Liquichek™ Urinalysis Control device and its substantial equivalence to a predicate device, focusing on its intended use as an assayed quality control urine to monitor the precision of urinalysis test procedures.
However, the document does not contain the level of detail typically found in a clinical study report that would establish acceptance criteria and prove the device meets them in the context of diagnostic accuracy, which is what your questions imply.
Instead, this document focuses on demonstrating substantial equivalence to a previously approved device (K965171), primarily through comparison of characteristics and stability studies for the control material itself.
Therefore, for most of your questions, the information is not available in the provided text. I will answer what can be inferred or directly stated from the document, and indicate "Not Applicable" or "Not Provided" where the information is absent or does not fit the context of this type of submission.
Acceptance Criteria and Device Performance for Liquichek™ Urinalysis Control
The acceptance criteria for this device are aligned with demonstrating its performance as a quality control material for monitoring the precision of urinalysis test procedures. The study described focuses on establishing the stability of the control material over time, both when sealed (shelf life) and after opening (open vial stability), which are critical performance aspects for a quality control product.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied for a Quality Control Material) | Reported Device Performance (from "Statement of Supporting Data") |
|---|---|
| Open Vial Stability: Maintain stability of all analytes after opening for a defined period. | 30 days at 2 to 8°C, or 7 days at room temperature (18 to 25°C), when stored tightly capped. |
| Shelf Life: Maintain stability of all analytes for a defined period when stored as directed. | 30 months when stored at 2 to 8°C. (Note: "Real time studies will be ongoing to support the shelf life of this product" indicates this is an initial claim based on accelerated or partial real-time data.) |
| Equivalence to Predicate Device: Similar intended use, form, matrix, storage, and analytes (with additions). | Demonstrated through comparative table (Section 6.0) and FDA's substantial equivalence determination. Additions include Creatinine and Protein-Creatinine Ratio. |
| Precision Monitoring: Ability to monitor the precision of urinalysis test procedures. | This is the intended use of the device, and its efficacy is assumed based on its nature as a quality control material and substantial equivalence to a predicate device already performing this function. No specific precision monitoring numerical performance (e.g., CV%) is given for the control material itself. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not explicitly stated in terms of number of runs or batches for the stability studies. The stability studies are typically performed on a selection of manufactured lots.
- Data Provenance: The studies were performed by Bio-Rad Laboratories, located in Irvine, California. The data would be considered prospective as it involves controlled stability testing of the newly formulated product.
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. For a quality control material, "ground truth" typically refers to the established target values and acceptable ranges for the analytes within the control. These are determined through extensive analytical testing and statistical analysis by laboratory personnel, not by clinical experts for diagnostic interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods like 2+1 or 3+1 are used in diagnostic studies where human readers interpret medical images or clinical data and their interpretations need to be reconciled. This document describes the performance of a laboratory quality control material, not a diagnostic device involving human interpretation of patient data.
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. This is a quality control material, not an AI-assisted diagnostic device. Therefore, no MRMC study, AI assistance, or human reader improvement analysis would be relevant or performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a quality control material, not an algorithm or an automated diagnostic system. Its "standalone" performance relates to its inherent stability and accuracy as a reference material.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For a quality control material, the "ground truth" (or reference values) for its analytes are established through highly characterized analytical methods and statistical analysis of multiple measurements. This is typically done in-house by the manufacturer's analytical chemistry and quality control departments using reference methods and calibrated instruments. This is not driven by expert clinical consensus, pathology, or outcomes data.
8. The sample size for the training set
Not applicable. The concept of a "training set" applies to machine learning algorithms or AI models. This device is a biochemical control material, not an AI product.
9. How the ground truth for the training set was established
Not applicable, as there is no "training set" in the context of this quality control material.
{0}------------------------------------------------
K03/231
Page 1 of 2
Summary of Safety and Effectiveness Liquichek™ Urinalysis 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 14, 2003
Device Identification 2.0
| Product Trade Name: | Liquichek™ Urinalysis Control |
|---|---|
| Common Name: | Urinalysis controls (Assayed and Unassayed) |
| Classifications: | Class I |
| Product Code: | JJW |
| Regulation Number: | CFR 862.1660 |
3.0 Device to Which Substantial Equivalence is Claimed
Liquichek™ Urinalysis Control Bio-Rad Laboratories Irvine, California
Docket Number: K965171
4.0 Description of Device
Liquichek™ Urinalysis Control is prepared from human urine with added human erythrocytes, simulated leukocytes, constituents of animal origin, pure chemicals, preservatives and stabilizers. The control is provided in liquid form for convenience.
5.0 Statement of Intended Use
Liquichek Urinalysis Control is intended for use as an assayed quality control urine to monitor the precision of urinalysis test procedures for the analytes listed in this package insert.
{1}------------------------------------------------
Comparison of the new device with the Predicate Device 6.0
The new Liquichek™ Urinalysis Control claims substantial equivalence to the Liquichek™ Urinalysis Control currently in commercial distribution (K965171).
| Bio-Rad | Bio-Rad | |
|---|---|---|
| Characteristics | Liquichek™ Urinalysis Control(New Device) | Liquichek™ Urinalysis Control(Predicate Device) |
| Similarities | ||
| Intended Use | Liquichek Urinalysis Control is intended foruse as an assayed quality control urine tomonitor the precision of urinalysis testprocedures for the analytes listed in thispackage insert. | Liquichek™ Urinalysis Control is intended foruse as an assayed quality control urine tomonitor the precision of laboratory dipstick andmicroscopic testing procedures for analyteslisted in this package insert. |
| Form | Liquid | Liquid |
| Matrix | Urine | Urine |
| Storage | 2°C to 8°CUntil expiration date | 2°C to 8°CUntil expiration date |
| Differences | ||
| Open Vial | 30 days at 2 to 8° C or 7 days at roomtemperature (18-25° C) | 30 days at 2-8° C or 10 immersions whichevercomes first or 7 days at room temperature (18to 25° C) or 10 immersions whichever comesfirst. |
| Preservatives | 5-chloro-2-methyl-2H-isothiazol-3-one | Level 2 contains Sodium Azide. |
| Squeezer Caps | Approved for Use | Not approved for use |
| Analytes | Same analytes as the predicate device withthe additional claims for Creatinine andProtein-Creatinine Ratio. | Does not have claims for Creatinine or Protein-Creatinine Ratio. |
7.0 Statement of Supporting Data
Stability studies have been performed to determine the open vial stability and shelf life for the Liquichek™ Urinalysis Control. Product claims are as follows:
- 7.1 Open vial: Once the control is opened and stored tightly capped, all analytes will be stable for 30 days at 2 to 8°C, or 7 days at room temperature (18 to 25°C).
- 7.2 Shelf Life: 30 months when stored at 2 to 8°C.
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.
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's symbol, which consists of three stylized human figures in a row, connected at the shoulders and facing to the right. The symbol is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
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
JUN 1 8 2003
K031231 Re:
Trade/Device Name: Liquichek™ Urinalysis Control Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJW Dated: April 14, 2003 Received: April 29, 2003
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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
{3}------------------------------------------------
Page 2 -
This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Steven Sutman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
510 (k) Number (if known): KQ3 123 |
Device Name: Liquichek™ Urinalysis Control
Indications for Use:
ر من المواليد
المستق
Liquichek Urinalysis Control is intended for use as an assayed quality control urine to monitor the precision of urinalysis test procedures for the analytes listed in this package insert.
Sean Cooper
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) 0.3123
(PLEASE DO NOT WRITE BELOW THE LINE-CONINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription use V 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.