(6 days)
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.
Liquichek Anti-RNP 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.
This document describes a 510(k) submission for the Bio-Rad Liquichek Anti-RNP Control, EIA. This product is an unassayed quality control for monitoring enzyme immunoassay procedures for the detection of ribonucleoprotein (RNP) autoantibodies. As such, it is a quality control product, not a diagnostic device intended to directly measure patient analytes. Therefore, the traditional performance metrics and study designs (e.g., sensitivity, specificity, reader studies, etc.) typically associated with diagnostic devices are not applicable in this context.
Instead, the review focuses on establishing substantial equivalence to a predicate device, specifically the Helix Enzyme Immunoassay Antinuclear Antibody Screening Test Kit, in terms of its characteristics as a quality control material.
Given the nature of the device as a quality control, the following information is not provided in the document and is generally not required for this type of submission:
- A table of acceptance criteria and reported device performance (in the diagnostic sense).
- Sample size used for the test set or data provenance (as there isn't a "test set" of patient samples in the traditional sense).
- Number of experts used to establish ground truth or their qualifications.
- Adjudication method.
- Multi-reader multi-case (MRMC) comparative effectiveness study.
- Standalone (algorithm-only) performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
The "study" implicitly revolves around demonstrating that the Liquichek Anti-RNP Control, EIA is suitable for its intended use as a control, and its characteristics are comparable to an existing, legally marketed control or a device against which it can be benchmarked for substantial equivalence.
Acceptance Criteria and Device Performance (as inferred for a quality control device):
The acceptance criteria for a quality control device primarily focus on its composition, stability, and suitability for monitoring the intended assay. Based on the provided 510(k) summary, the device's performance is demonstrated by its substantial equivalence to the predicate device in terms of its intended use, form, matrix, storage conditions, and relevant analytes.
| Acceptance Criteria (for a Quality Control Device) | Reported Device Performance (Bio-Rad Liquichek Anti-RNP Control, EIA) |
|---|---|
| Intended Use: Monitoring EIA procedures for RNP autoantibodies. | Intended Use: An unassayed quality control serum for monitoring enzyme immunoassay procedures for the detection of ribonucleoprotein (RNP) autoantibodies. (Matches predicate's broader use as an ANA screening test kit, but the Bio-Rad device is specifically an RNP control). |
| Form: Liquid. | Form: Liquid. (Substantially equivalent to predicate). |
| Matrix: Human Serum. | Matrix: Human Serum with added preservatives and stabilizers. (Substantially equivalent to predicate). |
| Levels: Provides appropriate control levels. | Levels: Negative, Positive, High Positive. (Predicate has Negative, Positive, Cutoff; Bio-Rad offers a "High Positive" for potentially broader monitoring). This difference does not negate equivalence for a control device. |
| Storage: Stable under specified storage conditions. | Storage: 2-8°C. (Substantially equivalent to predicate). |
| Analytes: Specific for RNP autoantibodies. | Analytes: Anti-RNP. (This defines its specificity as a control, aligning with the predicate's mention of SmRNP within its broader ANA panel, making it a suitable control for an RNP assay). |
| Open Vial Claim: Defined stability after opening. | Open Vial Claim: 30 Days at 2-8°C. (This provides specific shelf life information not explicitly detailed for the open vial predicate, but is a standard requirement for quality control materials). This demonstrates appropriate characterization of the control material, not a direct performance comparison against an identical predicate claim. |
The Study Proving the Device Meets Acceptance Criteria (as inferred from the 510(k) submission):
The "study" for this device is the process of comparing its characteristics and intended use to a legally marketed predicate device (Helix Enzyme Immunoassay Antinuclear Antibody Screening Test Kit) to establish substantial equivalence. The FDA's review and subsequent clearance (K984476) confirm that this comparison was satisfactory.
The provided information focuses on the descriptive aspects of the device and its comparison to the predicate rather than a clinical performance study. The key elements of this "study" are:
- Comparison Table: The document explicitly provides a table comparing the Bio-Rad Liquichek Anti-RNP Control, EIA with the Helix Enzyme Immunoassay Antinuclear Antibody Screening Test Kit across critical parameters such as intended use, form, matrix, levels, storage, and analytes. This table serves as the primary evidence for demonstrating substantial equivalence.
- Product Description: A detailed description of the device's composition (human serum with preservatives and stabilizers, liquid form) is provided to ensure its suitability as a control.
- Intended Use Statement: The stated intended use for monitoring RNP autoantibody EIA procedures is clearly defined, demonstrating its specific application.
In summary, for a quality control device like the Liquichek Anti-RNP Control, EIA, "acceptance criteria" are met by demonstrating that its physical and chemical properties, as well as its intended use, are consistent with established good manufacturing practices for control materials and are substantially equivalent to a legally marketed predicate device used for similar purposes in an immunoassay setting. No clinical "performance" study on patient samples is presented or typically required for this type of device.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image is a white background with some small, faint, and blurry dark spots scattered across it. The spots are irregularly shaped and distributed randomly. Due to the lack of distinct features, it is difficult to determine the exact nature or origin of the spots.
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.
Laboratories
California 92618-20 elembone (949) 598-1201
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 Pecember 14, 1998
Device (Trade & Common Name) Liquichek Anti-RNP Control, EIA
Classification Name Class II. 82LKO CFR 866.5100: Anti-RNP Antibody, Antigen and 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-RNP Control, EIA is intended for use as an unassayed quality control to monitor enzyme immunoassay procedures for the detection of ribonucleoprotein (RNP) autoantibodies.
{1}------------------------------------------------
Image /page/1/Picture/0 description: The image shows the logo for Bio-Rad. The logo is white text on a black, rounded rectangle. The text reads "BIO-RAD" with a plus sign in between the "BIO" and "RAD".
Bio-Rad Laboratories Diagnostics Group 9500 Jeronimo Road Irvine, California 92618-2017 Telephone: (949) 598-1200
Description of the Device
Liquichek Anti-RNP 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 Liquichek Anti-RNP Control, EIA and the device to which substantial equivalence is claimed.
| Helix Enzyme Immunoassay AntinuclearAntibody Screening Test Kit | Bio-Rad Liquichek Anti-RNPControl, 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 ofribonucleoprotein (RNP)autoantibodies. |
| Form | Liquid | Liquid |
| atrix | 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-RNP |
| Open VialClaim | Shelf life | 30 Days at 2-8°C |
{2}------------------------------------------------
Image /page/2/Picture/2 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three lines forming its body and wings. The eagle is oriented to the right. Encircling the eagle is text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
DEC 22 1998
Ms. Elizabeth Platt Staff Regulatory Affairs Representative BIO-RAD LABORATORIES 9500 Jeronimo Road Irvine, CA 92618-2017
Re: K984476 Trade Name: Liquichek Anti-RNP Control, EIA Model #207 Regulatory Class: II Product Code: LKO 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, qood 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 requlations affecting your device can be found in the Code of Federal Regulations, 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 requlations.
{3}------------------------------------------------
Page 2
This letter will allow you to begin 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
{4}------------------------------------------------
Page 1 of 1
149844 510(k) Number: J Device Name: Liquichek Anti-RNP Control, EIA
Indications for Use:
Liquichek Anti-RNP Control, EIA is intended for use as an unassayed quality control to Elquieren Inmunoassay procedures for the detection of ribonucleoprotein (RNP) 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 | |
| 510(k) Number | K984476 |
| 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).