(28 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 the 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 is related to the submission of a medical device for FDA approval (510(k) premarket notification) and does not describe acceptance criteria, performance studies, or efficacy data in the typical sense for a diagnostic algorithm or advanced medical device.
The "device" in question is the "Liquichek™ Urinalysis Control," which is a quality control solution for laboratory urinalysis tests. The purpose of this submission is to demonstrate substantial equivalence to a previously approved control solution, with the only addition being claims for "color and clarity."
Therefore, many of the requested elements (like sample size for test sets, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth types for training, etc.) are not applicable in this context. The study described is a stability study for the control solution itself, not a study evaluating the performance of a diagnostic device against a clinical outcome or expert consensus.
Here's an attempt to answer the questions based on the provided text, noting where information is not applicable:
1. A table of acceptance criteria and the reported device performance
Since this is a quality control material and not a diagnostic device, the "performance" relates to its stability. The acceptance criteria essentially define the stability required for its intended shelf life and open-vial use.
| Acceptance Criteria (Internal) | Reported Device Performance (Stability) |
|---|---|
| Open vial stability requirement | All analytes stable for 30 days at room temperature (18 to 25°C) when tightly capped. |
| Shelf life stability requirement | 30 months (when stored at 2 to 8°C). |
Note: The document states "All supporting data is retained on file at Bio-Rad Laboratories" and "Real time studies will be ongoing to support the shelf life of this product." This implies the "reported device performance" in terms of stability is based on conducted studies, but the specific raw data or detailed performance metrics (e.g., drift, acceptable range of variation) are not provided in this summary.
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 in the context of an algorithm or diagnostic device. For the stability studies of the control solution, the "sample size" would refer to the number of lots or vials tested over time. This information is not provided in the summary. The studies are prospective in nature, as they involve monitoring the product over time. The country of origin of the data is Bio-Rad Laboratories (Irvine, California, USA).
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. The "ground truth" for a quality control solution would be its known chemical and physical properties at different time points, measured by laboratory instrumentation, not expert human evaluation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication is used for interpreting ambiguous clinical data, which is not relevant here.
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 device is a quality control solution, not an AI-powered diagnostic tool, and involves no human readers or AI assistance in its function.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or AI device. The "performance" is the inherent stability of the chemical control solution over time.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the stability studies, the "ground truth" is likely the quantitative measurements of the analytes (e.g., concentration, pH, specific gravity) and qualitative observations (color, clarity) performed using standardized laboratory methods at defined time points. This is analogous to analytical accuracy or reference method values.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is not a machine learning or AI device that requires a training set.
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Summary of Safety and Effectiveness Liquichek™ Urinalysis Control
APR 2 5 2007
1.0 Submitter
Bio-Rad Laboratories 9500 Jeronimo Road, Irvine, California 92618-2017 Telephone: (949) 598-1200 Fax: (949) 598-1557
Contact Person
Suzanne Parsons Regulatory Affairs Specialist Telephone: (949) 598-1467
Date of Summary Preparation
March 26, 2007
2.0 Device Identification
| 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: K031231
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.
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6.0 Comparison of the new device with the Predicate Device
The new Liquichek Urinalysis Control claims substantial equivalence to the Liquichek Urinalysis Control currently in commercial distribution (K031231).
Liquichek Urinalysis Control claims substantial equivalence to the Liquichek Urinalysis Control currently in commercial distribution (K031231). Both of these controls are manufactured with exactly the same formulation. The only difference between the predicate device and the new Liquichek Urinalysis Control is that new product has claims for color and clarity and the predicate device does not.
| Characteristics | Bio-RadLiquichek™ Urinalysis Control(New Device) | Bio-RadLiquichek™ Urinalysis Control(Predicate Device) |
|---|---|---|
| Similarities | ||
| Intended Use | Liquichek Urinalysis Control is intendedfor 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 intended foruse as an assayed quality control urine to monitor the precision of laboratory dipstick and microscopic testing procedures for analytes listed 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 |
| Open Vial | 30 days at room temperature (18-25° C) | 30 days at room temperature (18-25° C) |
| Preservatives | 5-chloro-2-methyl-2H-isothiazol-3-one | 5-chloro-2-methyl-2H-isothiazol-3-one |
| Squeezer Caps | Approved for Use | Approved for Use |
| Differences | ||
| Analytes | Same analytes as the predicate devicewith the additional claims for color andclarity. | Does not have claims for color and clarity |
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:
- Qpen vial: Once the control is opened and stored tightly capped, all analytes will be stable 7.1 for 30 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.
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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 consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is depicted in black, and the text is also in black.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Bio-Rad Laboratories c/o Ms. Suzanne Parsons Regulatory Affairs Representative 9500 Jeronimo Road Irvine, California 92618-2017
APR 2 5 2007
Re: K070848 Trade/Device Name: Liquichek™M Urinalysis Control Regulation Number: 21 CFR 862.1660 Quality control material (assayed and unassayed) Regulation Name: Regulatory Class: Class I Product Code: JJW Dated: March 26, 2007 Received: March 28, 2007
Dear Ms. Parsons:
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).
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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 (240) 276-0490. 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 (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Jean M. Coopes, M.S., D.V.M.
Yean M. Cooper, M.S., D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name:
Indications For Use:
K070848 Liquichek™ Urinalysis Control
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 the package insert.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Carol C. Benson
Division Sign-Off
Office of In Vitro Diagnostic
Device Evaluation and Safety
Page 1 of __
510(k) K070848
§ 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.