(6 days)
Liquichek Anti-SS-A Control, EIA is intended for use as an unassayed quality control to monitor enzyme immunoassay procedures for the detection of SS-A autoantibodies.
Liquichek Anti-SS-A Control, EIA is prepared from human serum with added preservatives and stabilizers. This product is provided in liquid form for convenience. This product contains 0.1% sodium azide as a preservative.
The provided text describes a 510(k) summary for the Bio-Rad Liquichek Anti-SS-A Control, EIA. This device is an unassayed quality control for monitoring enzyme immunoassay procedures. As such, the concept of "accuracy" or "performance" as typically applied to diagnostic or AI devices (e.g., sensitivity, specificity, AUC) does not directly apply in the same way.
The primary acceptance criteria for a quality control device largely revolve around its stability, consistency, and chemical composition, to ensure it can reliably perform its intended function of monitoring other assays. The document focuses on demonstrating substantial equivalence to a predicate device, which is the regulatory pathway for this type of product.
Therefore, many of the requested points regarding acceptance criteria, study design for performance, sample sizes for test sets, expert adjudication, MRMC studies, and standalone algorithm performance are not applicable or directly addressed in the context of this specific product (quality control material).
Here's a breakdown of the information that can be extracted or inferred based on the nature of the device and the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
As a quality control material, the "performance" isn't about diagnostic accuracy. Instead, the "acceptance criteria" relate to its characteristics for fulfilling its role as a control. The document implies these criteria are met by demonstrating substantial equivalence to the predicate.
| Characteristic | Acceptance Criteria (Inferred from Substantial Equivalence Goal) | Reported Device Performance (Liquichek Anti-SS-A Control, EIA) |
|---|---|---|
| Intended Use | For monitoring EIA procedures for SS-A autoantibodies. | Unassayed quality control serum for monitoring enzyme immunoassay procedures for the detection of SS-A autoantibodies. |
| Form | Liquid | Liquid |
| Matrix | Human Serum | Human Serum |
| Levels | Negative, Positive, High Positive | Negative, Positive, High Positive |
| Storage | 2-8°C | 2-8°C |
| Analytes | Anti-SS-A | Anti-SS-A |
| Open Vial Claim | Defined shelf life after opening | 30 Days at 2-8°C |
| Preservatives | Stable, effective | Contains 0.1% sodium azide as a preservative. |
| Stabilizers | Stable | Contains stabilizers. |
Study to Prove Acceptance Criteria:
The study proving the device meets its "acceptance criteria" for substantial equivalence is the comparison to the predicate device (Helix Enzyme Immunoassay Antinuclear Antibody Screening Test Kit, K954723) as detailed in the "Statement of How Technological Characteristics Compare to Substantial Equivalent Device" table. The FDA's 510(k) clearance signifies acceptance of this comparison.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not applicable. This is not a diagnostic device requiring a test set of patient samples for performance evaluation (e.g., sensitivity/specificity). The evaluation focuses on the characteristics of the control material itself against a predicate.
- Data Provenance: Not applicable in the context of diagnostic performance data. The data provenance would relate to the manufacturing and characterization of the control material, which is implied to be from Bio-Rad Laboratories (Irvine, CA, USA).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. Ground truth, in the sense of clinical diagnosis or pathology, is not established for a quality control material. The "ground truth" for this device is its defined composition and behavior as a control, established through internal characterization and comparison to a predicate.
4. Adjudication Method for the Test Set
- Not applicable. There is no "test set" requiring adjudication in the context of a quality control material.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, a MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation, often with AI assistance, and does not apply to a quality control material.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
- No, a standalone algorithm performance study was not done. This device is not an algorithm, but a physical quality control reagent.
7. The Type of Ground Truth Used
- The "ground truth" for this quality control material is its defined composition and characteristics, and its demonstrated ability to function as a control for SS-A autoantibody detection, as established by the manufacturer and accepted by the FDA through the substantial equivalence process. This is implicitly based on laboratory characterization and comparison to the established predicate device.
8. The Sample Size for the Training Set
- Not applicable. This device is a biochemical control, not an AI algorithm requiring a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no training set for this type of device.
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DEC 2 2 398
Image /page/0/Picture/1 description: The image contains a sequence of handwritten digits and letters. The sequence appears to be 'K984470'. The characters are written in a bold, somewhat rough style, giving them a distinct and easily readable appearance. The contrast between the characters and the background is high, making the sequence stand out.
Image /page/0/Picture/2 description: The image shows the logo for BIO-RAD. The logo is white text on a black rounded rectangle. The text is in all caps and bolded.
Bio-Rad Laboratories Diagnostics Group 9500 Jeronimo Road vine, California 92618-2017 elephone: (949) 598-1200
510(k) Summary
Submitter Bio-Rad Laboratories 9500 Jeronimo Road Irvine, CA (949)598-1285 Fax (949)598-1555
Contact Person Elizabeth Platt
Date of Summary Preparation December 14, 1998
Device (Trade & Common Name) Liquichek Anti-SS-A Control, EIA
Classification Name Class II, 82LKJ CFR 866.5100: Antinuclear Antibody, Antigen, Control.
Devices to Which Substantial Equivalence is Claimed
Helix Enzyme Immunoassay Antinuclear Antibody Screening Test Kit Helix Diagnostics West Sacrament, California K954723
Statement of Intended Use
Liquichek Anti-SS-A Control, EIA is intended for use as an unassayed quality control to monitor enzyme immunoassay procedures for the detection of SS-A autoantibodies.
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Image /page/1/Picture/0 description: The image shows the logo for Bio-Rad. The logo is white text on a black background. The text is in a bold, sans-serif font.
Bio-Rad Laboratories Diagnostics Group 9500 Jeronimo Road Irvine, California 92618-2017 Telephone: (949) 598-1200
Description of the Device
Liquichek Anti-SS-A Control, EIA is prepared from human serum with added preservatives and stabilizers. This product is provided in liquid form for convenience. This product contains 0.1% sodium azide as a preservative.
Statement of How Technological Characteristics Compare to Substantial Equivalent Device A table is provided below comparing the similarities between the Bio-Rad Liguichek Anti-SS-A, EIA and the device to which substantial equivalence is claimed.
| Helix Enzyme Immunoassay AntinuclearAntibody Screening Test Kit | Bio-Rad Liquichek Anti-SS-AControl, EIA | |
|---|---|---|
| Intended Use | A qualitative enzyme immunoassay (EIA) forscreening the presence of antinuclearantibodies (ANAs) in human serum as an aidin the diagnosis of certain systemic rheumaticdiseases. | An unassayed quality controlserum for monitoring enzymeimmunoassay procedures forthe detection of SS-Aautoantibodies. |
| orm | Liquid | Liquid |
| Matrix | Human Serum | Human Serum |
| Levels | Negative, Positive, Cutoff | Negative, Positive, High Positive |
| Storage | 2-8°C | 2-8°C |
| Analytes | Total ANAs against:DNA (dsDNA, nDNA)HistonesSS-A/RoSS-B/LaSmSmRNPScl-70Jo-1Centrometric antigensSera positive for Immunofluorescent(IFA) Hep-2 ANAs | Anti-SS-A |
| Open VialClaim | Shelf life | 30 Days at 2-8°C |
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DEC 2 2 1998
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Elizabeth Platt Staff Regulatory Affairs Representative BIO-RAD LABORATORIES 9500 Jeronimo Road Irvine, CA 92618-2017
K984470 Re: Trade Name: Liquichek ANA-SS-A Control, EIA Model #209 Regulatory Class: II Product Code: LKJ Dated: December 14, 1998 December 16, 1998 Received:
Dear Ms. Platt:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 aqainst misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Paqe 2
This letter will allow you to beqin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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 Putman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Rage 20 510(k) Number: Device Name: Liquichek Anti-SS-A Control, EIA
Indications for Use:
Liquichek Anti-SS-A Control, EIA is intended for use as an unassayed quality control to monitor enzyme immunoassay procedures for the detection of Anti-SS-A autoantibodies.
(PLEASE DO NOT WRITE BELOW THE LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
(Concurrence of CDRH, Office of Device Evaluation)
(Division Sign-Off)
| Division of Clinical Laboratory Devices | K984470 |
|---|---|
| 510(k) Number |
| Prescription Use | |
|---|---|
| ------------------ | ------------- |
OR Over-The Counter Use
§ 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).