(21 days)
Liquichek Anti-RNP Control, Positive, is intended for use as an unassayed quality control to monitor indirect immunofluorescent testing for the detection of ribonucleoprotein (RNP) autoantibodies.
This product is prepared from human serum with added preservatives. The control is provided in liquid form for convenience.
This document describes a submission for a quality control device, not a diagnostic device that performs analysis on patient samples. Therefore, many of the requested fields are not applicable in this context.
Here's an analysis based on the provided text:
Acceptance Criteria and Device Performance (Not Applicable - This is a Quality Control Device)
This document describes a "Liquichek™ Anti-RNP Control, Positive" which is an unassayed quality control intended to monitor indirect immunofluorescent testing. It is not a diagnostic device that directly detects disease or provides a patient result. Therefore, the concept of "acceptance criteria" for a diagnostic performance (like sensitivity, specificity, accuracy) and "device performance" in terms of clinical outcomes or diagnostic accuracy are not applicable to this product.
Instead, the "performance" for a quality control device is typically related to its stability and its ability to consistently produce an expected qualitative result (e.g., positive). The acceptance criteria for this type of product would revolve around ensuring the control material remains stable and retains its intended properties for its labeled shelf-life and open-vial stability.
The Study Proving the Device Meets Criteria:
The study described is a stability study.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (for a Quality Control Device) | Reported Device Performance |
|---|---|
| Open-vial stability: Analyte stable for 60 days when stored tightly capped at 2 to 8°C. | The control remained stable for 60 days once opened when stored at 2-8°C, tightly capped. |
| Shelf-life: Control stable for 2 years when stored unopened at 2-8°C. | The control remained stable for 2 years when stored unopened at 2-8°C. |
Note: The document implies these were the performance claims derived from the stability studies, rather than explicitly stating pre-defined "acceptance criteria" in a numerical format. For a quality control, the "performance" is its ability to remain stable and provide the expected qualitative result for the specified duration.
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated for either stability study. The studies likely involved multiple vials of the control material tested at various time points.
- Data Provenance: Not specified, but generally, stability studies for medical devices are conducted at the manufacturer's facility (Bio-Rad Laboratories). The study type is prospective for the duration of the stability testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This is a quality control device. "Ground truth" in the clinical sense (e.g., disease presence) is not established for the control material itself. The "truth" for a control is its known positive reactivity for the target analyte, which is inherent in its manufacture.
4. Adjudication method for the test set:
- Not Applicable. As this is a quality control device undergoing stability testing, an adjudication method like 2+1 or 3+1 is not relevant. The stability evaluation typically involves analytical testing to confirm the continued reactivity and stability of the control material over time.
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 device, not an AI-powered diagnostic tool, and involves no human readers or AI assistance in its primary function.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not Applicable. This is a quality control device, not an algorithm or AI system.
7. The type of ground truth used:
- Not Applicable in the traditional sense of patient diagnosis. For a quality control material, the "truth" is its inherent composition and known reactivity for the specified analyte (Anti-RNP). This is established during its manufacturing process.
8. The sample size for the training set:
- Not Applicable. This is a quality control device and does not involve a "training set" in the context of machine learning or algorithm development.
9. How the ground truth for the training set was established:
- Not Applicable. See point 8.
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1024233
Summary of Safety and Effectiveness Liquichek™ Anti-RNP Control, Positive
1.0 Submitter
Bio-Rad Laboratories 9500 Jeronimo Road, Irvine, California 92618-2017 Telephone: (949) 598-1200 (949) 598-1555 Fax:
Contact Person
Yvette Lloyd Senior Regulatory Affairs Specialist Telephone: (949) 598-1465
Date of Summary Preparation
December 20, 2002
2.0 Device Identification
| Product Trade Name: | Liquichek™ Anti-RNP Control, Positive |
|---|---|
| Common Name: | Anti-RNP Antibody, Antigen and Control |
| Classifications: | Class II |
| Product Code: | 82LKO |
| Regulation Number: | 21 CFR 866.5100 |
3.0 Device to Which Substantial Equivalence is Claimed
Liquichek™ Anti-RNP Control, EIA Bio-Rad Laboratories
510 (k) Number: K984476
4.0 Description of Device
This product is prepared from human serum with added preservatives. The control is provided in liquid form for convenience.
JAN 1 3 2003
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5.0 Statement of Intended Use
The Liquichek™ Anti-RNP Control, Positive, is intended for use as an unassayed quality control to monitor indirect immunofluorescent testing for the detection of ribonucleoprotein (RNP) autoantibodies.
Comparison of the new device with the Predicate Device 6.0
This control is substantially equivalent to the following quality control material for autoimmune analysis that is currently in the market:
Liquichek™ Anti-RNP Control, EIA Bio-Rad Laboratories
510 (k) Number: K984476
Table 1. Similarities and Differences between new and predicate device.
| Characteristics | Liquichek™ Anti-RNP Control, Positive(New Device) | Liquichek™ Anti-RNP Control, EIA(Predicate Device) |
|---|---|---|
| Similarities | ||
| Matrix | Human Serum | Human Serum |
| Storage(Unopened) | 2°C to 8°Cuntil expiration date | 2°C to 8°Cuntil expiration date |
| Form | Liquid | Liquid |
| Analyte | Anti-RNP | Anti-RNP |
| Value Assignment | Unassayed | Unassayed |
| Differences | ||
| Intended Use | The Liquichek™ Anti-RNP Control, Positive, is intended for use as an unassayed quality control to monitor indirect immunofluorescent testing for the detection of ribonucleoprotein (RNP) autoantibodies. | The Liquichek™ Anti-RNP Control, EIA is intended for use as an unassayed quality control to monitor enzyme immunoassay procedures for the detection of ribonucleoprotein (RNP) autoantibodies. |
| Stability(Opened) | Once opened the analyte will be stable for 60 days. | Once opened the analyte will be stable for 30 days. |
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Summary of Performance Data 7.0
Stability studies have been performed to determine the open vial stability and shelf life for the Liquichek™ Anti-RNP Control, Positive. Product claims are as follows:
- 7.1 Once the control is opened the analyte will be stable for 60 days when stored tightly capped at 2 to 8°C.
- 7.2 The control is stable for 2 years when stored unopened at 2 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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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines representing hair or clothing.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JAN 1 3 2003
Ms. Yvette Lloyd Senior Regulatory Affairs Specialist Bio-Rad Laboratories. OSD 9500 Jeronimo Road Irvine, CA 92618-2017
Re: K024223
Trade/Device Name: LiquichekTM Anti-RNP Control, Positive Regulation Number: 21 CFR 866.5100 Regulation Name: Antinuclear antibody immunological test system Regulatory Class: Class II Product Code: LKJ Dated: December 20, 2002 Received: December 23, 2002
Dear Ms. Lloyd:
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). 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Steven Autman
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
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Page 1 of 1
510 (k) Number (if known):____________________________________________________________________________________________________________________________________________________
Device Name: Liquichek™ Anti-RNP Control, Positive
Indications for Use:
Liquichek Anti-RNP Control, Positive, is intended for use as an unassayed quality control to monitor indirect immunofluorescent testing for the detection of ribonucleoprotein (RNP) autoantibodies.
(PLEASE DO NOT WRITE BELOW THE LINE-CONINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription use_ or
Over-the Counter use
YP Reeves for J. Bautista
(Division Sign-Off) Division of Clinical Laboratory I 510(k) Number -
§ 866.5100 Antinuclear antibody immunological test system.
(a)
Identification. An antinuclear antibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoimmune antibodies in serum, other body fluids, and tissues that react with cellular nuclear constituents (molecules present in the nucleus of a cell, such as ribonucleic acid, deoxyribonucleic acid, or nuclear proteins). The measurements aid in the diagnosis of systemic lupus erythematosus (a multisystem autoimmune disease in which antibodies attack the victim's own tissues), hepatitis (a liver disease), rheumatoid arthritis, Sjögren's syndrome (arthritis with inflammation of the eye, eyelid, and salivary glands), and systemic sclerosis (chronic hardening and shrinking of many body tissues).(b)
Classification. Class II (performance standards).