MESACUP-2 TEST JO-1, MODEL 10756 by RHIGENE, INC.

The MESACUP-2 TEST Jo-1 is a semi-quantitative enzyme-linked immunosorbent assay (ELISA) for the detection of anti-Jo-1 antibodies in human serum as an aid in the diagnosis of polymyositis and/or dermatomyositis, or other related connective tissue diseases.

Device Description

The MESACUP-2 Test Jo-1 is an enzyme-linked immunosorbent assay (ELISA), utilizing the 96-microwell plate format, similar to the predicate device. Diluted serum samples, calibrator sera, and controls are incubated in microwells coated with Jo-1 (histidyl-tRNA synthetase) antigen. Incubation allows the anti-Jo-1 antibodies present in the samples to react with the immobilized antigen. After the removal of unbound serum proteins by washing, antibodies specific for human immunoglobulins (IgG, IgM and IgA), labeled with horseradish peroxidase (HRP), are added forming complexes with the Jo-1 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 (H2O2) as the chromogenic substrate. The intensity of the color generated is proportional to the serum concentration of anti-Jo-1 antibodics. Optical density is read spectrophotometrically at 450mm. The total incubation time (at room temperature) of the assay is 150 minutes. The assay makes use of two calibrators to measure the amount of anti-Jo-1 antibodies in patient samples.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the MESACUP-2 Test Jo-1, based on the provided text:

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
Clinical Specificity for anti-Jo-1 antibodies in a healthy donor serum population	98% (MESACUP-2 Test Jo-1) 100% (Predicate Device)
Clinical Sensitivity for anti-Jo-1 antibodies in a polymyositis/dermatomyositis population (previously positive by double immunodiffusion - DID)	100% (MESACUP-2 Test Jo-1) 85% (Predicate Device)
General performance characteristics comparability	Comparable between the two methods
Compliance with published literature for anti-Jo-1 detection	In compliance

Study Information

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

Test Set Sample Size:
- Healthy donor serum population: Not explicitly stated, but "in-house studies" are mentioned for specificity.
- Polymyositis/dermatomyositis population: Not explicitly stated, but "additional studies" are mentioned for sensitivity.
Data Provenance: Retrospective ("in-house studies" and "additional studies"). Country of origin is not specified, but the submission is from a US company (Corgenix Inc.).

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

Not specified. The ground truth for the sensitivity study was based on antibodies "previously also found positive by double immunodiffusion (DID)," which implies a prior established diagnosis, but the expert involvement in that initial diagnosis is not detailed.

4. Adjudication Method for the Test Set:

Not applicable. This is an ELISA assay detecting antibodies, not a diagnostic imaging or clinical assessment where adjudication between readers would typically occur.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:

Not applicable. This is an in-vitro diagnostic (IVD) device, specifically an ELISA. It does not involve human readers interpreting images or data with or without AI assistance.

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

Yes. The performance data (specificity and sensitivity) are for the device itself, the MESACUP-2 Test Jo-1, as a standalone diagnostic tool. The "human-in-the-loop" component in an ELISA is a laboratory technician performing the assay and reading the spectrophotometer, but the output (optical density and subsequent antibody concentration) is determined by the assay itself, not human interpretation in the sense of an AI-assisted diagnostic.

7. The Type of Ground Truth Used:

For Specificity: Healthy donor serum population (absence of disease/antibodies).
For Sensitivity: Polymyositis/dermatomyositis population with antibodies "previously also found positive by double immunodiffusion (DID)." This indicates a reference method (DID) was used to confirm the presence of anti-Jo-1 antibodies, serving as the ground truth for that cohort.

8. The Sample Size for the Training Set:

Not applicable. ELISA assays are not typically "trained" in the machine learning sense. Their performance is determined by their chemical and biological design, optimization, and validation against known samples.

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

Not applicable, as there isn't a training set in the machine learning context for this type of device. The ground truth for the validation/test sets was established as described in point 7.

Summary

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K033528

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SUMMARY OF 510(K) SAFETY AND EFFECTIVENESS MESACUP-2 Test Jo-1 December 2, 2003

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 MESACUP-2 Test Jo-1 is compared to a legally marketed predicate device and a substantial The predicate device is Quanta Lite Jo-1 ELISA (K926562) currently equivalence claim made. manufactured and marketed by Inova Diagnostics, Inc., San Diego, CA.

The intended use of the device is a semi-quantitative enzyme-linked immunosorbent assay (ELISA) for the detection of antibodies in human serum. as an aid in the diagnosis of polymyositis and/or dermatomyositis, or other related connective tissue diseases.

Performance indicates that MESACUP-2 Test Jo-1 and the Quanta Lite Jo-1 ELISA are equivalent. In-house studies indicate a clinical specificity of 98% and 100% for anti-Jo-1 antibodies in a healthy donor serum population respectively. Additional studies resulted a sensitivity of 100% and 85% with a polymyositis/dermatomyositis population on both assay respectively for antibodies previously also found positive by double immunodiffusion (DID). In general, the performance characteristics are comparable between the two methods. These results are also in compliance with those in published literature for anti-Jo-1 detection.

Nanci Denton

Nanci Dexter Director, Quality Assurance and Regulatory Affairs

2003-12-02

Date

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

DEC 2 2 2003

Rhigene, Inc. c/o Ms. Nanci Dexter Director of Quality and Regulatory Affairs Corgenix Inc. 12061 Tejon Street Westminster, CO 80234

Re: K033528

Trade/Device Name: MESACUP - 2 TEST Jo-1 Regulation Number: 21 CFR 866.5100 Regulation Name: Antinuclear antibody immunological test system Regulatory Class: Class II Product Code: LLL Dated: December 2, 2003 Received: December 3, 2003

Dear Ms. Dexter:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 adultcration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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 Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

510(k) Number: K033528

Device Name: MESACUP-2 TEST Jo-1

Indications for Use:

The MESACUP-2 TEST Jo-1 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)

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) Ko33528

Regulation Number and Section

§ 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).