(25 days)
Liquichek Anti-SS-B Control, Positive, is intended for use as an unassayed quality control to monitor indirect immunofluorescent testing for the detection of SS-B 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 details for the Liquichek™ Anti-SS-B Control, Positive, based on the provided document:
This document describes a new quality control device, and the "performance" referenced refers to its stability rather than diagnostic accuracy for patient samples. Therefore, typical metrics like sensitivity, specificity, or AUC based on clinical outcomes are not applicable.
Acceptance Criteria and Device Performance Study for Liquichek™ Anti-SS-B Control, Positive
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Product Claims) | Reported Device Performance (Study Results) |
|---|---|
| Open Vial Stability: Analyte stable for 60 days when stored tightly capped at 2 to 8°C. | The stability studies performed supported this claim. |
| Shelf Life: Control stable for 2 years when stored unopened at 2 to 8°C. | The stability studies performed supported this claim. Real-time studies are ongoing to support this claim. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a separate "test set" in the context of clinical performance, as this is a quality control product. The performance studies relate to the stability of the control material itself.
- Sample Size: Not explicitly stated as a number of distinct "samples" in the traditional sense. The studies would have involved multiple aliquots or units of the control material tested over time.
- Data Provenance: The studies were performed internally by Bio-Rad Laboratories. The data is retrospective in the sense that the studies were performed and data collected prior to this submission, but the "real-time studies will be ongoing" suggests a prospective element for shelf-life confirmation. Country of origin for data is implied to be within Bio-Rad's facilities, likely in the USA given the submission location (Irvine, California).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not applicable. For a quality control material, the "ground truth" is defined by the stability of the analyte within the control. This is determined through chemical and immunological assays over time, not by expert interpretation.
4. Adjudication Method
Not applicable. Adjudication methods are relevant for subjective interpretations (e.g., image reading) or conflicting results in diagnostic studies. This is a stability study for a quality control product.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. MRMC studies are used to evaluate the diagnostic performance of a device with and without AI assistance on human readers. This is a quality control product, not a diagnostic device for clinical use by human readers.
6. Standalone (Algorithm Only) Performance Study
Not applicable. This device is a biochemical control, not an algorithm. Its performance is chemical/biological stability.
7. Type of Ground Truth Used
The ground truth for the stability studies would be analytical measurements of the Anti-SS-B autoantibodies' concentration or activity within the control over time, under specified storage conditions. These measurements would be compared against predefined acceptable ranges for stability.
8. Sample Size for the Training Set
Not applicable. This document describes a quality control product, not an AI/algorithm-based device that requires a training set. The "training" for this product involves its manufacturing process and subsequent stability testing.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As above, there is no "training set" in the context of this chemical/biological quality control product. The product's intended performance (stability) is established through rigorous analytical testing and adherence to manufacturing specifications.
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Summary of Safety and Effectiveness Liquichek™ Anti-SS-B 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-SS-B 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-B Control, EIA Bio-Rad Laboratories
510 (k) Number: K984478
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 7 2003
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5.0 Statement of Intended Use
The Liquichek™ Anti-SS-B Control, Positive, is intended for use as an unassayed quality control to monitor indirect immunofluorescent testing for the detection of SS-B 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-B Control, EIA Bio-Rad Laboratories
510 (k) Number: K984478
Table 1. Similarities and Differences between new and predicate device.
| Characteristics | Liquichek™ Anti-SS-B Control, Positive(New Device) | Liquichek™ Anti-SS-B 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-B | Anti-SS-B |
| Value Assignment | Unassayed | Unassayed |
| Differences | ||
| Intended Use | The Liquichek™ Anti-SS-B Control, Positive, is intended for use as an unassayed quality control to monitor indirect immunofluorescent testing for the detection of SS-B autoantibodies. | The Liquichek™ Anti-SS-B Control, EIA is intended for use as an unassayed quality control to monitor enzyme ummunoassay procedures for the detection of SS-B 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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7.0 Summary of Performance Data
Stability studies have been performed to determine the open vial stability and shelf life for the Liguichek™ Anti-SS-B 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/0 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features an abstract eagle design with three profiles facing right, representing the department's focus on people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the eagle, with "DEPARTMENT OF HEALTH & HUMAN SERVICES" forming the outer circle and "USA" positioned at the top.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Ms. Yvette Lloyd Senior Regulatory Affairs Specialist Bio-Rad Laboratories, OSD 9500 Jeronimo Road Irvine, California 92618-2017
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JAN 1 7 2003
Re: K024232
Trade/Device Name: Liquichek™ Anti-SS-B 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): __ Koay &33-
Device Name: Liquichek™ Anti-SS-B Control, Positive
Indications for Use:
Liquichek Anti-SS-B Control, Positive, is intended for use as an unassayed quality control to monitor indirect immunofluorescent testing for the detection of SS-B 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) (Shoron of Clinical Laboratory Dexices 2 2 KU 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).