(18 days)
Liquichek Anti-Scl-70, Positive, is intended for use as an unassayed quality control to monitor indirect immunofluorescent testing for the detection of Scl-70 autoantibodies.
This product is prepared from human serum with added preservatives. The control is provided in liquid form for convenience.
Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets those criteria:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Product Claims) | Reported Device Performance |
|---|---|
| Open Vial Stability: Analyte stable for 60 days when stored tightly capped at 2 to 8°C. | "Once the control is opened the analyte will be stable for 60 days when stored tightly capped at 2 to 8°C." (Confirmed by stability studies.) |
| Shelf Life: Control stable for 2 years when stored unopened at 2 to 8°C. | "The control is stable for 2 years when stored unopened at 2 8°C." (Confirmed by stability studies, with real-time studies ongoing to support this claim.) |
| Intended Use: For use as an unassayed quality control to monitor indirect immunofluorescent testing for the detection of Scl-70 autoantibodies. | The device's intended use fully aligns with this claim. The 510(k) clearance confirms substantial equivalence for this intended use. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample size used for the stability studies. It only mentions that "Stability studies have been performed..."
The data provenance is retrospective, as the studies have already been performed. The country of origin of the data is implicitly the United States, as Bio-Rad Laboratories is based in Irvine, California, and submitted the control for FDA approval.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not provided in the document. The study focuses on product stability and performance as a quality control, not on diagnostic accuracy requiring expert interpretation of results.
4. Adjudication Method for the Test Set:
This information is not applicable and therefore not provided. The study is on the stability of a quality control product, not on diagnostic accuracy that would require human adjudication of results.
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:
This information is not applicable and therefore not provided. This device is an in-vitro diagnostic (IVD) quality control product, not an AI-assisted diagnostic tool for human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This information is not applicable and therefore not provided. This device is a quality control product; it does not involve an algorithm working independently. Its performance is related to its inherent stability as a biological reagent.
7. The Type of Ground Truth Used:
The "ground truth" for the stability studies is the measured concentration/activity of the Anti-Scl-70 analyte over time and under specified storage conditions. The studies assessed whether the analyte's characteristics remained within acceptable bounds given the stated storage parameters.
8. The Sample Size for the Training Set:
This information is not applicable and therefore not provided. The device is a quality control material and does not involve a "training set" in the context of machine learning or predictive modeling.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable and therefore not provided, as there is no "training set" for this type of device.
{0}------------------------------------------------
Summary of Safety and Effectiveness Liquichek™ Anti-Scl-70 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 Requlatory Affairs Specialist Telephone: (949) 598-1465
Date of Summary Preparation
December 20, 2002
2.0 Device Identification
| Product Trade Name: | Liquichek TM Anti-Scl-70 Control, Positive |
|---|---|
| Common Name: | Anti-Scl-70 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-Scl-70 Control, EIA Bio-Rad Laboratories
510 (k) Number: K984475
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 0 2003
Kory22le
{1}------------------------------------------------
Statement of Intended Use 5.0
The Liquichek™ Anti-Scl-70, Positive, is intended for use as an unassayed quality control to monitor indirect immunofluorescent testing for the detection of Scl-70 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-Scl-70 Control, EIA Bio-Rad Laboratories
510 (k) Number: K984475
Table 1. Similarities and Differences between new and predicate device.
| Characteristics | Liquichek™ Anti-Scl-70 Control, Positive(New Device) | Liquichek™ Anti-Scl-70 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-Scl-70 | Anti-Scl-70 |
| Value Assignment | Unassayed | Unassayed |
| Differences | ||
| Intended Use | The Liquichek™ Anti-Scl-70, Positive, is intended for use as an unassayed quality control to monitor indirect immunofluorescent testing for the detection of Scl-70 autoantibodies. | The Liquichek™ Anti-Scl-70 Control, EIA is intended for use as an unassayed quality control to monitor enzyme immunoassay procedures for the detection of scl-70 autoantibodies. |
| Stability(Opened) | Once opened the analyte will be stable for 60 days. | Once opened the analyte will be stable for 30 days. |
{2}------------------------------------------------
7.0 Summary of Performance Data
Stability studies have been performed to determine the open vial stability and shelf life for the Liquichek™ Anti-Scl-70 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.
{3}------------------------------------------------
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 0 2003
Ms. Yvette Lloyd Senior Regulatory Affairs Specialist Bio-Rad Laboratories, QSD 9500 Jeronimo Road Irvine, CA 92618-2017
Re: K024226 Trade/Device Name: Liquichek" Anti-Scl-70 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).
{4}------------------------------------------------
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 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
{5}------------------------------------------------
510 (k) Number (if known):____________________________________________________________________________________________________________________________________________________
Liquichek™ Anti-Scl-70 Control, Positive Device Name:
Indications for Use:
Liquichek Anti-Scl-70, Positive, is intended for use as an unassayed quality control to monitor indirect immunofluorescent testing for the detection of Scl-70 autoantibodies.
(PLEASE DO NOT WRITE BELOW THE LINE-CONINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription use
Over-the Counter use__________________________________________________________________________________________________________________________________________________________
A.P. Reeves for J. Bautista
or
(Division Sign-Off) (Division of Clinical Laboratory Devices on 4 1 2 2 h 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).