(116 days)
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Not Found
No
The document describes a standard enzyme immunoassay (EIA) for detecting antibodies. There is no mention of AI, ML, or any computational analysis beyond basic data processing for calculating index values. The performance studies are based on direct comparison to a predicate device, not on training or validation of an AI/ML model.
No.
This device is for in vitro diagnostic use only and is intended to aid in the diagnosis of a condition by detecting antibodies, not to treat or prevent a disease.
Yes
The "Intended Use / Indications for Use" section explicitly states "For in vitro diagnostic use only" and "For use as an aid in the diagnosis of systemic rheumatic disease, particularly Sjogren's Syndrome." These phrases clearly indicate its function as a diagnostic device.
No
The device is a solid-phase enzyme immunoassay (EIA) kit, which is a laboratory test kit containing reagents and microwells, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states: "For in vitro diagnostic use only."
- Nature of the Test: The test is performed on human serum, which is a biological sample taken from the body, and it detects antibodies to an antigen. This is a classic example of an in vitro diagnostic test.
- Device Description: The description details a "solid-phase enzyme immunoassay (EIA)," which is a common technique used in IVD testing.
- Performance Studies: The performance studies involve testing human serum specimens and comparing the results to a predicate device, which is typical for demonstrating the performance of an IVD.
All of these points strongly indicate that this device is intended for in vitro diagnostic use.
N/A
Intended Use / Indications for Use
For the qualitative and semi-quantitative detection of human antibodies to SSB nuclear antigen in uman serum by enzyme immunoassay. For manual use, or for use with the HyPrep System Plus. In Vitro Diagnostic Use Only.
- For in vitro diagnostic use only. 1.
-
- For the qualitative and semi-quantitative detection of IgG antibodies to SSB antigen in human serum by enzyme immunoassay.
-
- For use as an aid in the diagnosis of systemic rheumatic disease, particularly Sjogren's Syndrome.
-
- For manual use, or for use with the HyPrep System Plus semi-automated fluid handler.
Product codes (comma separated list FDA assigned to the subject device)
LLL
Device Description
The SeraQuest Anti-SSB 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 SSB nuclear antigen (Anti-SSB), in human serum.
The Calibrators in the SeraQuest Anti-SSB test set have been assigned Index values based on an in-house standard. Test results are reported as Index values.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Summary of Clinical Testing:
Of the 288 specimens tested, 27 were positive, and 252 were negative in both the SeraQuest and Shield tests (please see Table 1 below). Seven specimens which were negative by the Shield test, were positive in the SeraQuest test. One specimen which was negative in the Shield test, was equivocal in the SeraQuest test. One specimen which was positive in the Shield test, was negative in the SeraQuest test.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Relative sensitivity 96.4
Relative specificity 97.2
Overall agreement 99.6
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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).
0
APPENDIX 3 (revised 4/18/98).
Quest International, Inc., 1938 N.E. 148th Terrace, N. Miami, FL 33181 Page No. 17, g
JUN 1 5 1998
510(k) SUMMARY
| Applicant: | Quest International, Inc.
1938 N.E. 148th Terrace
North 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-SSB |
| Device Name: | Antinuclear antibody immunological test system (21CFR § 866.5100) |
| Device Classification: | Class II (performance standards) |
escription:
The SeraQuest Anti-SSB 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 SSB nuclear antigen (Anti-SSB), in human serum.
The Calibrators in the SeraQuest Anti-SSB 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 SSB antigen. Antibodies against SSB (if present) are immobilized in the wells. Residual sample is eliminated by washing and draining, and coniugate (enzyme-labeled antibodies to human IgG) is added and incubated, If IgG antibodies to SSB 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 vellow end-product which is read photometrically at 405 nm.
Intended Use:
For the qualitative and semi-quantitative detection of human antibodies to SSB nuclear antigen in uman serum by enzyme immunoassay. For manual use, or for use with the HyPrep System Plus. ാ In Vitro Diagnostic Use Only.
1
redicate Device:
:
The SeraQuest Anti-SSB test is substantially equivalent in intended use and performance, to the Shield Diastat Anti-SSB test, Shield Diagnostics, Dundee, DD2 1SW.
Summary of technological characteristics:
| Characteristic | SeraQuest Anti-SSB | Shield Diastat Anti-SSB |
|---|---|---|
| Description: | Enzyme Immunoassay | Enzyme Immunoassay |
| Intended Use: | The detection of | |
| antibodies against SSB | ||
| in human serum. | The detection of | |
| antibodies against SSB | ||
| in human serum. | ||
| Solid Phase: | Plastic Microwell | Plastic Microwell |
| Antigen Source: | Calf Thymus | Calf Thymus |
| Number of Incubation Periods: | Three | Three |
| ample Dilution: | 1:50 | 1:500 |
| Sample Incubation | ||
| Duration: | 30 minutes | 60 minutes |
| Incubation Temperature: | Room temperature | Room temperature |
| Ezyme-labeled Conjugate: | ||
| Antibody | Goat anti-human IgG | Goat anti-human IgG |
| Enzyme | Alkaline phosphatase | Alkaline phosphatase |
| Conjugate Volume: | 100 μl | 100 μl |
| Conjugate Incubation | ||
| Duration: | 30 minutes | 30 minutes |
| Substrate: | p-Nitrophenyl | |
| phosphate | phenolthalein | |
| monophosphate | ||
| Subtrate Volume: | ||
| Substrate Incubation | ||
| Duration: | 100 μl | |
| 30 minutes | 100 μl | |
| 30 minutes |
2
| top Reagent: | 0.5 M Trisodium
phosphate | Sodium
Hydroxide |
|----------------------|------------------------------|----------------------------------|
| Stop Reagent Volume: | 100 μl | 100 μl |
| Readout: | Spectrophotometric
405 nm | Spectrophotometric
540-565 nm |
Summary of Clinical Testing:
Of the 288 specimens tested, 27 were positive, and 252 were negative in both the SeraQuest and Shield tests (please see Table 1 below). Seven specimens which were negative by the Shield test, were positive in the SeraQuest test. One specimen which was negative in the Shield test, was equivocal in the SeraQuest test. One specimen which was positive in the Shield test, was negative in the SeraQuest test.
TABLE 1.
RESULTS OF SeraQuest Anti-SSB ASSAYS AND SHIELD Anti-SSB ASSAYS OF 288 SERUM SPECIMENS.
| SHIELD
Anti-SSB
| ASSAY | SeraQuest Anti-SSB | |||||
|---|---|---|---|---|---|---|
| Positive | Equivocal | Negative | % | 95 % Cl | ||
| Positive | 27 | 0 | 1 | Relative sensitivity 96.4 | 89.6 to100* | |
| Negative | 7 | 1 | 252 | Relative specificity | ||
| Overall agreement | 97.2 | |||||
| 99.6 | 95.3 to 99.3* | |||||
| 95.3 to 99.1* |
ア 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.
3
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles a human figure embracing another, representing care and support.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUN 1 5 1998
Mr. Robert A. Cort Vice President, Quality Assurance Ouest International, Inc. 1938 N.E. 148th Terrace North Miami, Florida 33181
Re : K980639/S1 Trade Name: SeraQuest® Anti-SSB Test System Requlatory Class: II Product Code: LLL 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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (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 requlation 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.
4
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
5
Quest International, Inc., 1938 N.E. 148th Terrace, N. Miami, FL 33181 Page No. 173
APPENDIX 8 (REVISED 4/17/98)
Page 1
510(k) Number (if known): _K980639
Device Name: SeraQuest Anti-SSB
Indications For Use:
- For in vitro diagnostic use only. 1.
-
- For the qualitative and semi-quantitative detection of IgG antibodies to SSB antigen in human serum by enzyme immunoassay.
-
- For use as an aid in the diagnosis of systemic rheumatic disease, particularly Sjogren's Syndrome.
-
- 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)
Rita G. Makin
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use - -
(Optional Format 1-2-96)