(19 days)
Liquichek Elevated CRP Control is intended for use as a quality control serum to monitor the precision of laboratory testing procedures for C-Reactive Protein (CRP).
Liquichek Elevated CRP Control is prepared from human serum with added constituents of human and animal origin, stabilizers, and preservatives. This product is provided in liquid form.
The provided document, K042837, is a 510(k) Pre-Market Notification for the "Liquichek Elevated CRP Control" device. This device is a quality control material intended to monitor the precision of laboratory testing for C-Reactive Protein (CRP).
The document details the device's characteristics and compares it to a predicate device, focusing on its intended use, form, matrix, and preservatives. Crucially, it discusses stability studies as the primary evidence for the device meeting its performance claims.
Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are related to its stability, specifically its shelf life and open vial stability. The reported device performance is that it meets these stability claims.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Open vial stability (after opening) | 30 days at 2°C to 8°C |
| Shelf life stability (unopened) | 3 years at -10°C to -70°C |
Study Proving Device Meets Acceptance Criteria
The document states: "Stability studies have been performed to determine the open vial stability and shelf life for the Liquichek Elevated CRP Control."
Unfortunately, the document does not provide detailed information about the study itself, such as the methodology, sample size, data provenance, ground truth establishment, or any direct comparative effectiveness study. It only states that "All supporting data is retained on file at Bio-Rad Laboratories."
Therefore, based solely on the provided text, the following information cannot be extracted:
- Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not specified in the document.
- 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 stability study of a quality control material. The "ground truth" would likely be laboratory measurements of CRP concentration over time under specified conditions.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable for a stability study.
- 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: This is not an AI/imaging device, so an MRMC study is not relevant.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable as this is not an algorithm-based device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For a quality control material, the ground truth for stability would be the measured concentration of CRP at various time points under controlled storage conditions, assessed against a defined reference method or expected range. This is inherently a chemical/analytical measurement, not an expert opinion or pathology.
- The sample size for the training set: Not applicable, as this is not a machine learning device that requires a training set.
- How the ground truth for the training set was established: Not applicable for the same reason as above.
In summary, the provided document explicitly states that stability studies were conducted to determine the open vial and shelf life stability, and the results of these studies demonstrated that the device meets its claimed stability periods. However, the details of these studies are not disclosed within the document itself, only that the data is on file with the manufacturer.
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NOV - 2 2004
Summary of Safety and Effectiveness Liquichek Elevated CRP Control
1.0 Submitter
Bio-Rad Laboratories 9500 Jeronimo Road, Irvine, California 92618-2017 (949) 598-1200 Telephone: (949) 598-1557 Fax:
Contact Person
Suzanne Parsons Regulatory Affairs Specialist Telephone: (949) 598-1467
Date of Summary Preparation
October 12, 2004
2.0 Device Identification
| Product Trade Name: | Liquichek Elevated CRP Control |
|---|---|
| Common Name: | Single (specified) analyte controls (assayed and unassayed) |
| Classifications: | Class 1 |
| Product Code: | JJX |
| Regulation Number: | 21 CFR 862.1660 |
3.0 Device to Which Substantial Equivalence is Claimed
Liquichek™ Lipids Control Bio-Rad Laboratories Irvine, California
510 (k) Number: K012513
4.0 Description of Device
Liquichek Elevated CRP Control is prepared from human serum with added constituents of human and animal origin, stabilizers, and preservatives. This product is provided in liquid form.
5.0 Intended Use
Liquichek Elevated CRP Control is intended for use as a quality control serum to monitor the precision of laboratory testing procedures for C-Reactive Protein (CRP).
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Comparison of the new device with the Predicate Device 6.0
Liquichek Elevated CRP Control claims substantial equivalence to the Liquichek Lipids Control currently in commercial distribution (K012513). Both of these are liquid, human serum based controls. Liquichek Elevated CRP Control contains only CRP and Liquichek Lipids Control is a multi-analyte control.
| Bio-Rad Laboratories | Bio-Rad Laboratories | |
|---|---|---|
| LiquichekTM Elevated CRP Control | LiquichekTM Lipids Control | |
| Characteristics | (New Device) | (Predicate Device K012513) |
| Similarities | ||
| Intended Use | Liquichek Elevated CRP Control is intended for use as aquality control serum to monitor the precision of laboratorytesting procedures for C-Reactive Protein (CRP). | Liquichek Lipids Control is intended for use as an assayed qualitycontrol serum to monitor the precision of laboratory testingprocedures for the analytes listed in the package insert. |
| Form | Liquid | Liquid |
| Matrix | Human serum based | Human serum based |
| Preservatives | Contains preservatives | Contains preservatives |
| Differences | ||
| Storage (Unopened) | -10 to -70°CUntil expiration date | -10°C to -20°CUntil expiration date |
| Open Vial Claim | 30 days at 2°C to 8 °C | 14 days at 2 to 8°C |
| Analytes | Contains:C-Reactive Protein (CRP) Does not Contain: Apolipoprotein A-1 Apolipoprotein B Cholesterol Cholesterol HDL Cholesterol LDL Lipoprotein (a) Triglycerides | Contains: Apolipoprotein A-1 Apolipoprotein B Cholesterol Cholesterol HDL Cholesterol LDL C-Reactive Protein (CRP) Lipoprotein (a) Triglycerides |
| Table 1. Similarities and Differences between new and predicate device. |
|---|
| ------------------------------------------------------------------------- |
Statement of Supporting Data 7.0
Stability studies have been performed to determine the open vial stability and shelf life for the Liquichek Elevated CRP Control. Product claims are as follows:
- 30 days at 2°C to 8 °C 7.1 Open vial
- Shelf Life Stability 3 Years at -10 to -70°C 7.2.
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 features a stylized caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol. The logo is black and white.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
NOV - 2 2004
Ms. Elizabeth Platt Quality Assurance/Regulatory Affairs Manager Bio-Rad Laboratories, QSD 9500 Jeronimo Road Irvine, CA 92618-2017
Re: K042837
Trade/Device Name: Liquichek Elevated CRP Control Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJX Dated: October 11, 2004 Received: October 14, 2004
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).
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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,
Jean M. Cooper, U.S. DVM.
Jean M. Cooper, MS, 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):
Ko42837
Device Name:
Liquichek Elevated CRP Control
Indications For Use:
Liquichek Elevated CRP Control is intended for use as a quality control serum to monitor the precision of laboratory testing procedures for C-Reactive Protein (CRP).
Prescription Use ਮ (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 Benson
Page 1 of
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K042837
§ 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.