(45 days)
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No
The device description details a standard ELISA assay, which is a biochemical test and does not involve AI or ML for data processing or interpretation.
No.
The device is an in-vitro diagnostic assay used to aid in the diagnosis of certain diseases by detecting specific antibodies, not to treat or prevent disease.
Yes
The device is described as an "aid in the diagnosis of polymyositis and/or dermatomyositis, or other related connective tissue diseases," directly indicating its diagnostic purpose.
No
The device description clearly outlines a physical ELISA kit with microwell plates, reagents, and a spectrophotometric reading process, indicating it is a hardware-based diagnostic assay, not software only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's 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." This involves testing a sample taken from the human body (serum) in vitro (outside the body) to provide information for diagnosis.
- Device Description: The description details an ELISA assay, which is a common laboratory technique performed in vitro on biological samples.
- Intended User / Care Setting: It's intended for use by "clinical (hospital and reference) laboratories," which are settings where in vitro diagnostic testing is performed.
All these points align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
LLL
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
The MESACUP-2 TEST Jo-1 is intended to be used by clinical (hospital and reference) laboratories.
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
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.
Key Metrics
clinical specificity of 98% and 100% for anti-Jo-1 antibodies in a healthy donor serum population respectively.
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).
Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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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).
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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 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.
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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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and head. The eagle is positioned to the right of a circular arrangement of text. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in all capital letters.
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
3
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 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.
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