For the qualitative detection of human IgM antibodies to Rubella virus in human serum by enzyme immunoassay, to aid in the diagnosis of Rubella infection. A positive result is presumptive for the detection of rubella antibodies and presumptive for the diagnosis of active or recent rubella infection. For manual use, or for use with the HyPrep System Plus. For In Vitro Diagnostic Use Only.

For the qualitative detection of IgM antibodies to Rubella in human serum by enzyme immunoassay, to aid in the diagnosis of Rubella infection.
A positive result is presumptive for the detection of anti-rubella antibodies and presumptive for the diagnosis of acute or recent rubella infection.
Useful for the above indications, with specimens obtained from women of childbearing age.
For manual use, or for use with the HyPrep System Plus semi-automated fluid handler.

Device Description

The SeraQuest Rubella IgM 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 IgM antibodies which are directed against Rubella virus, in human serum.

The Calibrators in the SeraQuest Rubella IgM test set have been assigned Index values based on an in-house standard. Test results are reported as Index values.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the SeraQuest Rubella IgM Device, based on the provided text:

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
Overall agreement with predicate device (excluding equivocal results)	97.7% agreement with Diamedix Rubella IgM Microassay.

Study Details

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: 91 archival serum specimens.
Data Provenance:
- 49 specimens from patients presenting with symptoms consistent with rubella infection.
- 42 specimens reported to be positive for IgM antibodies to rubella, obtained from serum brokers.
- All specimens were tested at Quest International, Inc., Miami, FL. (Retrospective data, as samples were "archival").

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts:

Number of Experts: Not specified.
Qualifications of Experts: Not specified.
- Note: The ground truth appears to be based on the results of a legally marketed predicate device (Diamedix Rubella IgM Microassay) and a second legally marketed device for discordant results, rather than expert interpretation of a gold standard independent of these assays.

4. Adjudication Method for the Test Set:

Adjudication Method: Specimens giving discordant results between the SeraQuest Rubella IgM test and the Diamedix Rubella IgM Microassay were tested with a second legally marketed device. A representative number of positive and negative samples with concordant results were also tested with this second device. This implies a form of tie-breaking or verification using an additional assay.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

MRMC Study: No, this was not an MRMC study. This study compares the performance of a new device against a predicate device, not human readers with and without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Standalone Performance: Yes, the device's performance was evaluated in a standalone manner, directly comparing its results (Index values indicating IgM antibodies) against a predicate device. The "algorithm" here refers to the immunoassay itself and its interpretation criteria, not a digital algorithm in the typical AI sense.

7. The Type of Ground Truth Used:

Ground Truth: The "ground truth" for evaluating the SeraQuest Rubella IgM device was the results obtained from a legally marketed predicate device (Diamedix Rubella IgM Microassay), and for discordant results, a second legally marketed device. This is a form of comparative ground truth against an established commercial assay.

8. The Sample Size for the Training Set:

Training Set Sample Size: Not specified. The document primarily describes the clinical testing for validation, not the development or training of the assay. The Calibrators used had Index values based on an "in-house standard," which suggests an internal process for setting assay parameters, but not a separate "training set" in the context of machine learning.

9. How the Ground Truth for the Training Set Was Established:

Training Set Ground Truth: Not explicitly detailed. The document mentions "Calibrators in the SeraQuest Rubella IgM test set have been assigned Index values based on an in-house standard." This implies an internal process for calibration and standardization during the device's development, rather than a separate "ground truth" derived from patient samples with independently confirmed disease status for a training set.

Summary

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OCT 16 1998

Quest International, Inc., 1938 N.E. 148th Terrace, N. Miami, FL 33181

APPENDIX 5, revised.

510(k) SUMMARY

Quest International, Inc. Applicant: 1938 N.E. 148th Terrace North Miami, FL 33181
May 15, 1998 Date prepared:
Contact person: Robert A. Cort. President
(305) 948-8788 Telephone:
Telefax: (305) 948-4876

SeraQuest Rubella IgM Device:

Device Classification: Class III (premarket approval)

Rubella serological reagents (21CFR § 866.3510) Device Name:

Description:

The Calibrators in the SeraQuest Rubella IgM 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 Rubella virus antibodies directed against rubella (if present) are immobilized in the wells. Residual sample is eliminated by washing and draining, and conjugate (enzyme-labeled antibodies to human IgM) is added and incubated. If IgM antibodies to Rubella are present, the conjugate will be immobilized in the wells. Residual conjugate is eliminated by washing and training, 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:

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APPENDIX 5, revised.

Predicate device:

The SeraQuest Rubella IgM test has been shown to be substantially equivalent to the Diamedix Rubella IgM kit, Diamedix Corporation, Miami, FL.

Summary of technological characteristics:

Characteristic	SeraQuest Rubella IgM	Diamedix Rubella IgM Microassay
Description:	Enzyme Immunoassay	Enzyme Immunoassay
Intended Use:	The detection of IgMantibodies against Rubellavirus in human serum.	The detection of IgMantibodies against Rubellavirus in human serum.
Antigen Strain	HPV-77	Not stated inpackage insert
Solid Phase:	Plastic Microwell	Plastic Microwell
Number of Incubation Periods:	Three	Three
Sample Dilution:	1:26	1:41
Sample Volume:	100 µl	100 ul
Sample PretreatmentDuration:	None	None
Sample IncubationDuration:	30 minutes	30 minutes
Incubation Temperature:	Room temperature	Room temperature
Ezyme-labeled Conjugate:
Antibody	Goat anti-human IgM	Goat anti-human IgM
Enzyme	Alkaline phosphatase	Alkaline phosphatase
Conjugate Volume:	100 ul	100 µl
Conjugate IncubationDuration:Substrate:	30 minutes	30 minutes
	p-Nitrophenylphosphate	p-Nitrophenylphosphate
	Quest International, Inc., 1938 N.E. 148th Terrace, N. Miami, FL33181Page No.
APPENDIX 5, revised.
Subtrate Volume:	100 µl	100 µl
Substrate IncubationDuration:	30 minutes	30 minutes
Stop Reagent:	0.5 M Trisodiumphosphate	0.5 M Trisodiumphosphate
Stop Reagent Volume:	100 µl	100 µl
Readout:	Spectrophotometric405 nm	Spectrophotometric405 nm

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Summary of Clinical Testing:

Experimental Procedure

Ninty-one archival serum specimens including: 49 specimens from patient presenting with symptoms consistent with rubella infection and 42 specimens reported to be positive for IgM antibodies to rubella which were obtained from serum brokers, were tested at Quest International. Inc., concurrently by the SeraQuest Rubella IgM test and the Diamedix Rubella IgM Microassay. The assays were performed and interpreted according to the manufacturers package inserts. Specimens giving discordant results were tested with a second legally marketed device, along with a representative number of positive and negative samples which gave concordant results by both test methods.

Results and Conclusion

Of the 91 specimens tested, 46 were positive, and 40 were negative in both the SeraQuest and Diamedix tests (please see Table 1). Of the 5 remaining specimens which were negative by the Diamedix test were positive by the SeraQuest test, and 3 specimens which were positive by the Diamedix test were negative in the SeraQuest test.

Excluding the equivocal results, the overall agreement between the SeraQuest Rubella IgM test, and the Diamedix Rubella IgM Microassay, was 97.7 percent.

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APPENDIX 5, revised.

TABLE 1.

RESULTS OF SeraQuest RUBELLA IgM ASSAYS, AND DIAMEDIX RUBELLA IgM MICROASSAYS, OF 91 SERUM SPECIMENS. THE SPECIMENS INCLUDED: 49 SPECIMENS FROM PATIENTS PRESENTING WITH SYMPTOMS CONSISTENT WITH RUBELLA INFECTION, AND 42 SPECIMENS REPORTED TO BE POSITIVE FOR IgM ANTIBODIES TO RUBELLA, WHICH WERE OBTAINED FROM SERUM BROKERS. THESE TESTS WERE PERFORMED IN-HOUSE AT QUEST INTERNATIONAL, INC., MIAMI, FL.

DiamedixRubellaIgM	SeraQuest Rubella IgM
	Positive	Equivocal	Negative
Positive	46	0	0
Negative	2	3	40

Agreement excluding equivocal results, 97.7 %

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the top half of the circle. Inside the circle is a stylized symbol that resembles three human profiles facing to the right, stacked on top of each other, with flowing lines beneath them.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

OCT 16 1998

Robert A. Cort Vice President, Quality Assurance Quest International, Inc. 1938 N.E. 148th Terrace North Miami, FL 33181

Re: K982281 Trade Name: SeraQuest Rubella IgM Regulatory Class: III Product Code: LFX Dated: August 24, 1998 Received: August 31, 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 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 regulations 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 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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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 Sutman

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.

Page 1 of of 1

510(k) Number (if known):

Device Name: SeraQuest Rubella IgM

Indications For Use:

(Per 21 CFR 801.109)

APPENDIX 10

For the qualitative detection of IgM antibodies to Rubella in human serum by 1. enzyme immunoassay, to aid in the diagnosis of Rubella infection.
A positive result is presumptive for the detection of anti-rubella antibodies and 2. presumptive for the diagnosis of acute or recent rubella infection.
Useful for the above indications, with specimens obtained from women of 3. childbearing age.
For manual use, or for use with the HyPrep System Plus semi-automated fluid 4. handler.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

	Woody Dubois(Division Sign-Off)Division of Clinical Laboratory Devices
510(k) Number	K98 2281

Prescription Use	X	OR	Over-The-Counter Use
------------------	---	----	----------------------

(Optional Format 1-2-96)

Regulation Number and Section

§ 866.3510 Rubella virus serological reagents.

(a)
Identification. Rubella virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to rubella virus in serum. The identification aids in the diagnosis of rubella (German measles) or confirmation of a person's immune status from past infections or immunizations and provides epidemiological information on German measles. Newborns infected in the uterus with rubella virus may be born with multiple congenital defects (rubella syndrome).(b)
Classification. Class II. The special controls for this device are:(1) National Committee for Clinical Laboratory Standards':
(i) 1/LA6 “Detection and Quantitation of Rubella IgG Antibody: Evaluation and Performance Criteria for Multiple Component Test Products, Speciment Handling, and Use of the Test Products in the Clinical Laboratory, October 1997,”
(ii) 1/LA18 “Specifications for Immunological Testing for Infectious Diseases, December 1994,”
(iii) D13 “Agglutination Characteristics, Methodology, Limitations, and Clinical Validation, October 1993,”
(iv) EP5 “Evaluation of Precision Performance of Clinical Chemistry Devices, February 1999,” and
(v) EP10 “Preliminary Evaluation of the Linearity of Quantitive Clinical Laboratory Methods, May 1998,”
(2) Centers for Disease Control's:
(i) Low Titer Rubella Standard,
(ii) Reference Panel of Well Characterized Rubella Sera, and
(3) World Health Organization's International Rubella Standard.