(25 days)
Liquichek Anti-SS-A Control, Positive, is intended for use as an unassayed quality control to monitor indirect immunofluorescent testing for the detection of SS-A autoantibodies.
This product is prepared from human serum with added preservatives. The control is provided in liquid form for convenience.
Here's a breakdown of the acceptance criteria and the study information for the Liquichek™ Anti-SS-A Control, Positive, based on the provided document:
This document describes a quality control product, not a diagnostic device that directly assesses patient conditions. Therefore, the typical "performance" metrics for a diagnostic device (e.g., sensitivity, specificity, AUC) are not applicable. Instead, the acceptance criteria relate to the stability and consistency of the control material.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Open Vial Stability | Analyte stable for 60 days when stored tightly capped at 2-8°C after opening. |
| Shelf Life (Unopened) | Control is stable for 2 years when stored unopened at 2-8°C. |
Study Details:
Based on the provided document, the study conducted is a stability study.
1. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated. The document refers to "supporting data" and "real time studies" but doesn't provide specific sample numbers of control vials tested.
- Data Provenance: Not explicitly stated regarding country of origin. The study is described as "Real-time studies will be ongoing," which suggests a prospective study design for shelf life, and the open vial stability would also be prospective. All data is retained by Bio-Rad Laboratories.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable directly. This is a quality control product, not a diagnostic device requiring expert interpretation for ground truth. The "ground truth" here is the inherent stability of the control material over time, measured through established laboratory assays.
3. Adjudication method for the test set:
- Not applicable as there's no diagnostic interpretation requiring adjudication.
4. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done:
- No, an MRMC study was not done. This type of study is for evaluating observer performance with and without an assist device for diagnostic tasks.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm-based device.
6. The type of ground truth used:
- The ground truth for this device's performance is the measured stability of the Anti-SS-A analyte within the control material over defined time periods (60 days open, 2 years unopened) when subjected to specific storage conditions. This would be determined by repeatedly testing the control material using accepted laboratory methods for Anti-SS-A detection and ensuring the results remain within a predefined acceptable range.
7. The sample size for the training set:
- Not applicable. This is a quality control product undergoing stability testing, not a machine learning algorithm that requires a training set.
8. How the ground truth for the training set was established:
- Not applicable. (See #7).
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Summary of Safety and Effectiveness Liquichek™ Anti-SS-A Control, Positive
1.0 Submitter
JAN 1 7 2003
Bio-Rad Laboratories 9500 Jeronimo Road, Irvine, California 92618-2017 (949) 598-1200 Telephone: Fax: (949) 598-1555
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-SS-A Control, Positive |
|---|---|
| Common Name: | Antinuclear Antibody, Antigen and Control |
| Classifications: | Class II |
| Product Code: | 82LKJ |
| Regulation Number: | 21 CFR 866.5100 |
3.0 Device to Which Substantial Equivalence is Claimed
Liquichek™ Anti-SS-A Control, EIA Bio-Rad Laboratories
510 (k) Number: K984470
4.0 Description of Device
This product is prepared from human serum with added preservatives. The control is provided in liquid form for convenience.
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5.0 Statement of Intended Use
The Liguichek™ Anti-SS-A Control. Positive. is intended for use as an unassaved quality control to monitor indirect immunofluorescent testing for the detection of SS-A autoantibodies.
6.0 Comparison of the new device with the Predicate Device
This control is substantially equivalent to the following quality control material for autoimmune analysis that is currently in the market:
Liquichek™ Anti-SS-A Control, EIA Bio-Rad Laboratories
510 (k) Number: K984470
Table 1. Similarities and Differences between new and predicate device.
| Characteristics | Liquichek™ Anti-SS-A Control,Positive(New Device) | Liquichek™ Anti-SS-A 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-SS-A | Anti-SS-A |
| ValueAssignment | Unassayed | Unassayed |
| Differences | ||
| Intended Use | The new Liquichek™ Anti-SS-AControl, Positive, is intended foruse as an unassayed qualitycontrol to monitor indirectimmunofluorescent testing for thedetection of SS-A autoantibodies. | The Liquichek™ Anti-SS-AControl, EIA is intended for use asan unassayed quality control tomonitor enzyme immunoassayprocedures for the detection ofSS-A autoantibodies. |
| Stability(Opened) | Once opened the analyte will bestable for 60 days. | Once opened the analyte will bestable for 30 days. |
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7.0 Summary of Performance Data
Stability studies have been performed to determine the open vial stability and shelf life for the Liquichek™ Anti-SS-A Control, Positive. Product claims are as follows:
- Once the control is opened the analyte will be stable for 60 days when 7.1 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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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 stylized eagle with three wing segments, representing health, services, and people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Yvette Lloyd Senior Regulatory Affairs Specialist Bio-Rad Laboratories, QSD 9500 Jeronimo Road Irvine, California 92618-2017
JAN 1 7 2003
Re: K024218
Trade/Device Name: Liquichek™ Anti-SS-A Control, Positive Regulation Number: 21 CFR § 866.5100 Regulation Name: Antinuclear Antibody Immunological Test System Regulatory 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). 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.
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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
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510 (k) Number (if known): 长负贸斗况18
Device Name: Liquichek™ Anti-SS-A Control, Positive
Indications for Use:
Liquichek Anti-SS-A Control, Positive, is intended for use as an unassayed quality control to monitor indirect immunofluorescent testing for the detection of SS-A 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 | |
|---|---|---|---|
| ------------------ | -------------------------------------------------- | ---- | ----------------------------------------------------------------------- |
J. Reeves for J. Bautista
(Division Sign-Off)
Division of Clinical Laboratory Devices
(k) Number K024218
§ 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).