(151 days)
The REAADS IgG anti-B2GPI Test Kit is an in vitro diagnostic assay for the detection and semi-quantitation of IgG anti-B2GPI antibodies in human serum as an aid for assessing the risk of thrombosis in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (antiphospholipid syndrome).
The REAADS IgG anti-B2GPI Test Kit is an enzyme-linked immunosorbent assay (ELISA), utilizing the 96microwell plate format, similar to the predicate device. Diluted serum samples, calibrator sera, and controls are incubated in microwells coated with purified human Beta-2 Glycoprotein I. Incubation allows the anti-B2GPI antibodies present in the samples to react with the immobilized antigen. After the removal of unbound serum proteins by washing, antibodies specific for human IgG, labeled with horseradish peroxidase (HRP), are added forming complexes with the B2GPI bound antibodies. Following another washing step, the bound enzyme-antibody conjugate is assayed by the addition of a single solution containing tetramethlybenzidine (TMB) and hydrogen peroxide (H,O,) as the chromogenic substrate. The intensity of the color generated is proportional to the serum concentration of anti-B2GPI antibodies. Optical density is read spectrophotometrically at 450mm. The total incubation time (at room temperature) of the assay is 40 minutes. The assay makes use of a single point callbrator to measure the amount of IgG anti-B2GPI antibodies in patient samples.
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Acceptance Criteria and Study Details for REAADS IgG anti-B2GPI Test Kit
1. Table of Acceptance Criteria and Reported Device Performance:
The provided document does not explicitly state pre-defined acceptance criteria in terms of numerical thresholds for specificity, sensitivity, or correlation that the device had to meet to be considered acceptable. Instead, it describes the observed performance characteristics and asserts their equivalence to the predicate device and compliance with published literature.
| Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Specificity | High (equivalent to predicate, compliant with literature) | 100% for IgG anti-B2GPI antibodies (in-house studies) |
| Clinical Sensitivity | Adequate (equivalent to predicate, compliant with literature) | 32% for unselected SLE patients (in-house studies) |
| Correlation with Predicate | Good correlation (statistically similar results) | 0.834 (coefficient of correlation) for individual values in unselected SLE patients |
| Statistical Similarity (P-value) | P-value indicating statistical similarity between methods | P-value of 0.05 (by single factor ANOVA) |
2. Sample Size and Data Provenance for the Test Set:
- Sample Size Used for Test Set: Not explicitly stated. The document refers to "in-house studies" and "unselected SLE patients" but does not provide the number of patients or samples included in these studies.
- Data Provenance: Not explicitly stated. Given the context of "in-house studies," it is likely proprietary data from CORGENIX, INC. There is no mention of country of origin or whether it was retrospective or prospective data.
3. Number of Experts and Qualifications for Ground Truth:
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
4. Adjudication Method for the Test Set:
- Adjudication Method: Not mentioned. The document primarily focuses on the quantitative comparison of the new device to the predicate.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- MRMC Study Done? No. This device is an in-vitro diagnostic (IVD) assay, not an imaging or diagnostic device requiring human interpretation of visual data in the same way an MRMC study would apply. Therefore, a comparative effectiveness study involving human readers with and without AI assistance is not applicable.
6. Standalone Performance:
- Standalone Performance Done? Yes. The described performance metrics (specificity, sensitivity, correlation) are for the REAADS IgG anti-B2GPI Test Kit operating as a standalone assay, independent of human interpretation beyond typical laboratory procedures. The document assesses the algorithm's performance (the test kit's ability to detect and semi-quantitate antibodies) directly.
7. Type of Ground Truth Used:
- Type of Ground Truth: The document implies that the ground truth for establishing "specificity" and "clinical sensitivity" was clinical diagnosis of SLE patients and the presence/absence of IgG anti-B2GPI antibodies, likely determined by other established diagnostic methods or clinical criteria. The comparison to the predicate device (QUANTA Lite IgG anti B2GPI ELISA) suggests that the predicate's results served as a comparative "truth" for evaluating the new device's performance in terms of correlation. There is no mention of pathology or outcomes data being the primary ground truth.
8. Sample Size for the Training Set:
- Sample Size for Training Set: Not mentioned. The document does not describe the development or training of the assay (e.g., in a machine learning context). Instead, it describes a comparison of a newly developed assay to an existing predicate.
9. How Ground Truth for the Training Set Was Established:
- How Ground Truth for Training Set Was Established: Not applicable. The document describes an ELISA kit, which is a biochemical assay. There is no mention of a "training set" or a process that would require establishing a ground truth for it, as would be the case for machine learning algorithms. The assay's performance is intrinsically linked to its biochemical design rather than learned parameters from a data set.
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Mars I 1908
SUMMARY OF 510(K) SAFETY AND EFFECTIVENESS
REAADS IgG anti-B2GPI Test Kit
July 8, 1998
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The REAADS IgG anti-B2GPI Test Kit is compared to a legally marketed predicate device and a substantial equivalence claim made. The predicate device is QUANTA Lite IgG anti B2GPI ELISA (K970551) currently manufactured and marketed by INOVA Diagnostics, Inc., San Diego, California.
The REAADS IgG anti-B2GPI Test Kit is an enzyme-linked immunosorbent assay (ELISA), utilizing the 96microwell plate format, similar to the predicate device. Diluted serum samples, calibrator sera, and controls are incubated in microwells coated with purified human Beta-2 Glycoprotein I. Incubation allows the anti-B2GPI antibodies present in the samples to react with the immobilized antigen. After the removal of unbound serum proteins by washing, antibodies specific for human IgG, labeled with horseradish peroxidase (HRP), are added forming complexes with the B2GPI bound antibodies. Following another washing step, the bound enzyme-antibody conjugate is assayed by the addition of a single solution containing tetramethlybenzidine (TMB) and hydrogen peroxide (H,O,) as the chromogenic substrate. The intensity of the color generated is proportional to the serum concentration of anti-B2GPI antibodies. Optical density is read spectrophotometrically at 450mm. The total incubation time (at room temperature) of the assay is 40 minutes. The assay makes use of a single point callbrator to measure the amount of IgG anti-B2GPI antibodies in patient samples.
The intended use of the detection and semi-quantitation of IgG anti-B2GPI antibodies in human serum as an aid for assessing the risk of thrombosis in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (antiphospholipid syndrome). Most autoimmune anti-phospholipid antibodies require a serum cofactor (B2GPI) for optimal binding. It has been shown that many anti-phospholipid antibodies may react to a neoepitope formed on the B2GPI molecule by the interaction between the phospholipid and B2GPI. In addition, it has been reported that anti-B2GPI antibodies are more specific for thrombosis than antibodies detected by classic antiphospholipid ELISAs. Testing for antibodies in the clinical laboratory by ELISA is becoming increasingly valuable and provides additional clinically relevant results for the antiphospholipid syndrome and/or the risk of thrombosis.
Performance indicates that REAADS anti-Beta-2 Glycoprotein I and the QUANTA Lite IgG anti B2GPI ELISA are equivalent. In-house studies indical specificity of 100% for IgG anti-B2GPI antibodies and a clinical sensitivity of 32% for unselected SLE patients. The coefficient of correlation for individual values in unselected SLE patients showed a good correlation of 0.834 with a P-value of 0.05 (by single factor ANOVA), indicating the results by the two methods are statistically similar. Although differences between the observed, in general, the performance characteristics are comparable. These results are also in compliance with those in published literature for antiphospholipid syndrome detection. The clinical studies performed demonstrate that the REAADS IgG anti-B2GPI Test Kit is safe and effective.
Nancy Dexter
Nanci Dexter Director, Quality Assurance and Regulatory Affairs
07/08/98
Date
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Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
DEC 7 1998 Nanci Dexter Director, Quality and Regulatory Affairs CORGENIX, INC. 12061 Tejon Street Westminster, CO 80234
Re: K982391 Trade Name: REAADS IqG Anti-B2GPI Test Kit Requlatory Class: II Product Code: MSV Dated: November 16, 1998 November 18, 1998 Received:
Dear Ms. Dexter:
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 against 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 Regulation (QS) for Medical Devices: General regulation (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 Reqister. 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.
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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 Butman
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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Indications for Use Statement
| 510(k) Number: | K 9823911 |
|---|---|
| ----------------------- | ----------- |
Device Name:
Indications for Use:
The REAADS IgG anti-B2GPI Test Kit is an in vitro diagnostic assay for the detection and semi-quantitation of IgG anti-B2GPI antibodies in human serum as an aid for assessing the risk of thrombosis in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (antiphospholipid syndrome).
The REAADS IgG anti-B2GPI Test Kit is intended to be used by clinical (hospital and reference) laboratories.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescriptioni ✓
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Peter E. Machin
Division Sign-Off) Division of Clinical Laboratory Device 510(k) Number .
§ 866.5660 Multiple autoantibodies immunological test system.
(a)
Identification. A multiple autoantibodies immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoantibodies (antibodies produced against the body's own tissues) in serum and other body fluids. Measurement of multiple autoantibodies aids in the diagnosis of autoimmune disorders (disease produced when the body's own tissues are injured by autoantibodies).(b)
Classification. Class II (performance standards).