(123 days)
- For in vitro diagnostic use only.
- For the qualitative and semi-quantitative detection of IgG antibodies to Sm in human serum by enzyme immunoassay.
- For use as an aid in the diagnosis of systemic lupus erythematosus (SLE).
- For manual use, or for use with the HyPrep System Plus semi-automated fluid handler.
The SeraQuest Anti-Sm test is a solid-phase enzyme immunoassay (EIA), which is performed in microwells, at room temperature, in three thirty minute incubations. It has been developed to detect IgG antibodies which are directed against Sm nuclear antigen (Anti-Sm) , in human serum. The Calibrators in the SeraQuest Anti-Sm test set have been assigned Index values based on an in-house standard. Test results are reported as Index values.
This document describes the 510(k) summary for the SeraQuest® Anti-Sm immunological test system.
1. Table of Acceptance Criteria and Reported Device Performance
The device's performance is demonstrated through a comparative study against a predicate device. While explicit "acceptance criteria" are not listed as predefined thresholds for sensitivity, specificity, and agreement, the study results are presented to support substantial equivalence.
| Metric | Acceptance Criteria (Implied) | Reported Device Performance (SeraQuest Anti-Sm vs. Shield Diastat Anti-Sm) |
|---|---|---|
| Relative Sensitivity | High agreement with predicate positive results | 90.9% (95% CI: 73.9 to 100) |
| Relative Specificity | High agreement with predicate negative results | 93.2% (95% CI: 89.9 to 96.5) |
| Overall Agreement | High overall concordance | 93.1% (95% CI: 89.9 to 96.4) |
2. Sample Size and Data Provenance
- Test Set Sample Size: 236 serum specimens.
- Data Provenance: The study was performed at Quest International, Inc., Miami, FL. The document does not explicitly state the country of origin of the serum specimens, but given the company location, it is likely the data is from the USA. It is a retrospective study as existing serum specimens were tested.
3. Number of Experts and Qualifications for Ground Truth
The document does not mention the use of experts to establish a ground truth for the test set. Instead, the performance is evaluated by comparison to a predicate device, the Shield Diastat Anti-Sm test. The "ground truth" for the performance metrics is based on the results obtained from the predicate device.
The table does include a row indicating "Number of patients with clinically diagnosed SLE." for positive cases, which suggests some clinical diagnosis context, but this is not explicitly stated as the primary ground truth for the comparative study's performance metrics. For the 236 specimens, 10 were positive for clinically diagnosed SLE.
4. Adjudication Method for the Test Set
No adjudication method is described. The comparison is direct between the SeraQuest Anti-Sm test and the Shield Diastat Anti-Sm test.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was mentioned. This device is an in vitro diagnostic (IVD) assay, not an imaging or diagnostic device that requires human interpretation.
6. Standalone Performance Study
Yes, a standalone performance study was done in the sense that the SeraQuest Anti-Sm test was run independently on 236 serum specimens, and its results were then compared to those obtained from the predicate device. The performance metrics (relative sensitivity, specificity, and agreement) are a direct result of this independent testing and subsequent comparison.
7. Type of Ground Truth Used
The primary "ground truth" or reference for the performance metrics (sensitivity, specificity, and agreement) in this study is the predicate device's results (Shield Diastat Anti-Sm test). The comparative study aims to show that the new device performs substantially equivalently to the predicate.
Additionally, for the positive cases, it's mentioned that 10 were "patients with clinically diagnosed SLE," indicating that clinical diagnosis (a form of outcomes data or expert clinical assessment) serves as an underlying reference for the predicate device's intended use and, by extension, the new device's claim for aiding in SLE diagnosis. However, the performance metrics of sensitivity, specificity, and agreement are calculated against the predicate device's results.
8. Sample Size for the Training Set
The document does not provide any information about a "training set" or sample size used for training. This likely indicates that the device's development did not involve a machine learning model, but rather a traditional laboratory assay development process.
9. How the Ground Truth for the Training Set was Established
Since no training set is mentioned for the device itself (as it's an immunoassay, not an AI/ML device), this information is not applicable.
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APPENDIX 3. (revised 4/17/98)
JUN 1 5 1998
510(k) SUMMARY
$ 866.5100)
| Applicant: | Quest International, Inc.1938 N.E. 148th TerraceNorth Miami, FL 33181 |
|---|---|
| Registration No. | 1061839 |
| Contact Person: | Robert A. Cort, V.P. , Quality Assurance |
| Telephone: | (305) 948-8788 |
| Telefax: | (305) 948-4876 |
| Manufacturing Site: | Same as above |
| Device: | SeraQuest® Anti-Sm |
| Device Name: | Antinuclear antibody immunological test system (21CFR) |
Device Classification: Class II (performance standards)
Description:
Ine SeraQuest Anti-Sm test is a solid-phase enzyme immunoassay (EIA), which is performed in microwells, at room temperature, in three thirty minute incubations. It has been developed to detect IgG antibodies which are directed against Sm nuclear antigen (Anti-Sm) , in human serum.
The Calibrators in the SeraQuest Anti-Sm test set have been assigned Index values based on an in-house standard. Test results are reported as Index values.
Principle:
Diluted samples are incubated in wells coated with Sm antibodies against Sm (if present) are immobilized in the wells. Residual sample is eliminated by washing and draining, and conjugate (enzyme-labeled antibodies to human IgG) is added and incubated. If IgG antibodies to Sm are present, the conjugate will be immobilized in the wells. Residual conjugate is eliminated by washing and draining, and the enzyme substrate is added and incubated. In the presence of the enzyme, the substrate is converted to a yellow end-product which is read photometrically at 405 nm.
Intended Use:
For the qualitative and semi-quantitative detection of human antibodies to Sm nuclear antigen in human serum by enzyme immunoassay. For manual use, or for use with the HyPrep System Plus.
r In Vitro Diagnostic Use Only.
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Tredicate Device:
The SeraQuest Anti-Sm test is substantially equivalent in intended use and performance, to the Shield Diastat Anti-Sm test, Shield Diagnostics, Dundee, DD2 1SW.
Summary of technological characteristics:
| Characteristic | SeraQuest Anti-Sm | Shield Diastat Anti-Sm |
|---|---|---|
| Description: | Enzyme Immunoassay | Enzyme Immunoassay |
| Intended Use: | The detection ofantibodies against Smin human serum. | The detection ofantibodies against Smin human serum. |
| Solid Phase: | Plastic Microwell | Plastic Microwell |
| Antigen Source: | Calf Thymus | Calf Thymus |
| Number of Incubation Periods: | Three | Three |
| Sample Dilution: | 1:50 | 1:500 |
| Sample IncubationDuration: | 30 minutes | 60 minutes |
| Incubation Temperature: | Room temperature | Room temperature |
| Enzyme-labeled Conjugate: | ||
| Antibody | Goat anti-human IgG | Goat anti-human IgG |
| Enzyme | Alkaline phosphatase | Alkaline phosphatase |
| Conjugate Volume: | 100 µl | 100 µl |
| Conjugate IncubationDuration: | 30 minutes | 30 minutes |
| Substrate: | p-Nitrophenylphosphate | phenolthaleinmonophosphate |
| Subtrate Volume:Substrate IncubationDuration: | 100 µl30 minutes | 100 µl30 minutes |
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Stop Reagent:
0.5 M Trisodium phosphate
Sodium Hydroxide
Stop Reagent Volume:
Readout: - ·
Spectrophotometric 405 nm
100 ul
Spectrophotometric 540-565 nm
100 µl
Summary of Clinical Testing:
Of the 236 specimens tested, 10 were positive, and 207 were negative in both the SeraQuest and Shield tests (please see Table C-3). Of the remaining specimens which were negative by the Shield test. 15 were positive and 3 equivocal by the SeraQuest test. One specimen which was positive by the Shield Diastat Anti-Sm test, was negative in the SeraQuest test. Please see Table 1 below.
TABLE 1.
RESULTS OF SeraQuest ANTI-Sm ASSAYS AND SHIELD DIASTAT ANTI-Sm ASSAYS OF 236 SERUM SPECIMENS. PERFORMED AT QUEST INTERNATIONAL. INC., MIAMI, FL.
| SHIELDDIASTATAnti-Sm | SeraQuest Anti-Sm | ||||
|---|---|---|---|---|---|
| Positive | Equivocal | Negative | % | 95 % CI | |
| Positive | 10 {5} | 0 | 1 {0} | Relative sensitivity 90.9 | 73.9 to 100 |
| Negative | 15 {7} | 3 {0} | 207 {38} | Relative specificity* 93.2 | 89.9 to 96.5 |
| Overall agreement* 93.1 | 89.9 to 96.4 |
Number of patients with clinically diagnosed SLE. ﺎﻟﺴﺎ ﺑﺎ ﻤﻴﺔ
Excluding equivocal results.
Calculated by the normal method.
Reference: Gardner, M.J. and Altman, D.G., Confidence Intervals Rather Than Hypothesis Testing. Brit. Med. J., 292: 746-750, 1986.
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Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three curved lines representing wings or feathers. The symbol is positioned to the right of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The text is arranged around the top half of the circle.
JUN 1 5 1998
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Robert A. Cort Vice President, Quality Assurance Ouest International, Inc. 1938 N.E. 148th Terrace North Miami, Florida 33181
Re : K980540/S1 Trade Name: SeraQuest® Anti-Sm Regulatory Class: II Product Code: LKP Dated: April 20, 1998 Received: April 24, 1998
Dear Mr. Cort:
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 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 regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 A substantially equivalent determination assumes compliance to 895. with the current Good Manufacturing Practice requirement, 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 Regulations.
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Page 2
Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770)488-7655.
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 at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/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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Quest International, Inc., 1938 N.E. 148th Terrace, N. Miami, FL 33181 Page No. 126
APPENDIX 7 (REVISED 4/17/98)
Page _ 1 of ﻠﺴ
510(k) Number (if known): __ K980540_
Device Name: SeraQuest Anti-Sm
Indications For Use:
-
- For in vitro diagnostic use only.
-
- For the qualitative and semi-quantitative detection of IgG antibodies to Sm in human serum by enzyme immunoassay.
- For use as an aid in the diagnosis of systemic lupus erythematosus (SLE). 3.
-
- For manual use, or for use with the HyPrep System Plus semi-automated fluid handler.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Otter E. Madion
(Division Sign-Off) (Division of Clinical Laboratory Devices 510(k) Number
Prescription Use _V (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
§ 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).