The ImmunoCard STAT! Rotavirus Immunoassay is a rapid in vitro qualitative procedure for the detection of rotavirus antigen in human stool. The test can be used to aid in the diagnosis of rotavirus associated gastroenteritis.
For use to detect the presence of rotavirus in stool specimens from patients with loose stools, diarrhea, gastroenteritis, or suspected to be infected with rotavirus.

Device Description

The ImmunoCard STAT! Rotavirus assay system is a membrane based immunogold assay for rotavirus. Each kit contains the following components: ImmunoCard STAT! Rotavirus devices(30), Positive Control (1.8ml), Sample Diluent (10.5ml), Transfer Pipets (30). In brief, 1/15 diluted stool enters the sample application pad and migrates through the conjugate pad. Monoclonal antibody (conjugated to colloidal gold particles) contained in the pad is dissolved in the specimen and travels onto the nitrocellulose membrane. The nitrocellulose membrane contains two "capture" zones. The first holds polyclonal antibody to rotavirus, and the second has polyclonal anti-mouse IgG. The first zone serves as the test line, indicating the presence of rotavirus. The second zone acts as a procedural control and verifies that the sample has migrated sufficiently into the device to permit a valid test result to be read in the first (test) zone. The final absorbent pad acts as a reservoir and draws the sample through the test strip.

AI/ML Overview

{
  "1. A table of acceptance criteria and the reported device performance": {
    "Performance vs Electron Microscopy": {
      "Acceptance Criteria": "Not explicitly stated as numerical criteria, but implied to be comparable to predicate devices.",
      "Sensitivity": "93.1%",
      "Specificity": "95.8%",
      "Correlation": "94.4%"
    },
    "Performance vs Premier Rotaclone (Predicate Device)": {
      "Acceptance Criteria": "Not explicitly stated as numerical criteria, but implied demonstration of substantial equivalence.",
      "Sensitivity": "97.7%",
      "Specificity": "100.0%",
      "Correlation": "98.8%"
    },
    "Sensitivity Limits": {
      "Acceptance Criteria": "Not explicitly stated as numerical criteria.",
      "Reported Performance": "Approximately 1.8-3.7 x 10^6 viral particles."
    },
    "Reproducibility": {
      "Acceptance Criteria": "Not explicitly stated as numerical criteria.",
      "Reported Performance": "100% on controls, negative and moderate positive stools, and 96% on low positive stools."
    },
    "Cross-Reactivity": {
      "Acceptance Criteria": "No false positive or false negative results with a panel of bacteria and viruses.",
      "Reported Performance": "Met the criteria: gave no false positive or false negative results."
    },
    "Interfering Substances": {
      "Acceptance Criteria": "Barium sulfate should not have an effect. High levels of blood may affect flow, potentially causing an occasional invalid result.",
      "Reported Performance": "No effect from barium sulfate. High levels (≥33%) of blood could affect flow, resulting in an occasional invalid test result (consistent with criteria)."
    }
  },
  "2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)": "The sample size for the clinical test set is not explicitly stated in the provided text. The data provenance (country of origin, retrospective or prospective) is also not specified.",
  "3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)": "Not applicable/Not specified. The ground truth for the core performance evaluation was established using Electron Microscopy and a predicate device (Premier Rotaclone), not necessarily human expert consensus for individual case adjudication.",
  "4. Adjudication method (e.g. 2+1, 3+1, none) for the test set": "Not applicable/Not specified. The performance was referenced against Electron Microscopy and a predicate device, not human adjudication of a test set.",
  "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 device, not an AI-assisted diagnostic tool for human readers.",
  "6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done": "Yes, the device performance metrics (sensitivity, specificity, correlation) are presented as standalone performance evaluations against Electron Microscopy and a predicate device, indicating algorithm-only performance.",
  "7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)": "The primary ground truth used for performance comparison was **Electron Microscopy**. A second comparison was also made against the **Premier Rotaclone** predicate device.",
  "8. The sample size for the training set": "Not applicable. For this type of in vitro diagnostic device (immunoassay), there isn't typically a 'training set' in the machine learning sense. The device's capture and detection antibodies are developed and optimized through laboratory work, not by 'training' on a dataset.",
  "9. How the ground truth for the training set was established": "Not applicable, as there is no traditional 'training set' for this immunoassay device."
}

Summary

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K471585

510(k) Summary ImmunoCard STAT! Rotavirus

ﻤﺴﯿﺴﯿﺪ

Meridian Diagnostics, Inc. Cincinnati, Ohio 45244

APPENDIX A - 510(k) Summary

A. Identification Information

AUG 20 1997

1. Submitter's Information:
- a) Submitter's Name and Address:

Meridian Diagnostics, Inc. 3471 River Hills Drive Cincinnati. OH 45244

b) Phone Number: 1-800-543-1980
c) Contact Person: Allen D. Nickol, PhD Director of Scientific and Regulatory Affairs
d) Date Summary Prepared: April 30, 1997
1. Name of Device: ImmunoCard STAT Rotavirus.

Classification Name: Enzyme Linked Immunoabsorbent Assay, Rotavirus.

Predicate Equivalent Device: Premier Rotaclone and Abbott Test Pack EIA's. 3)
Description of Device: The ImmunoCard STAT! Rotavirus assay system is a 4) membrane based immunogold assay for rotavirus. Each kit contains the following components:
- a) ImmunoCard STAT! Rotavirus devices(30)
- b) Positive Control (1.8ml)
- c) Sample Diluent (10.5ml)
- d) Transfer Pipets (30)

In brief, 1/15 diluted stool enters the sample application pad and migrates through the conjugate pad. Monoclonal antibody (conjugated to colloidal gold particles) contained in the pad is dissolved in the specimen and travels onto the nitrocellulose membrane. The nitrocellulose membrane contains two "capture" zones. The first holds polyclonal antibody to rotavirus, and the second has polyclonal anti-mouse IgG. The first zone serves as the test line, indicating the presence of rotavirus. The second zone

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acts as a procedural control and verifies that the sample has migrated sufficiently into the device to permit a valid test result to be read in the first (test) zone. The final absorbent pad acts as a reservoir and draws the sample through the test strip.

Intended Use: The ImmunoCard STAT! Rotavirus Immunoassay is a rapid in vitro 5) qualitative procedure for the detection of rotavirus antigen in human stool. The test can be used to aid in the diagnosis of rotavirus associated gastroenteritis.

Comparison with Predicate Devices: 6)

The following comparison of the use, technology, function and performance supports the Statement of Equivalence between the ImmunoCard STAT! Rotavirus test and enzyme immunoassay testing (Premier Rotaclone® and Abbott Test Pack®).

Method	ImmunoCard STAT!Rotavirus	PremierRotaclone	AbbottTest Pack
Intended Use	Detection of rotavirus in patient stool
Results	Qualitative
Technology	Immunoassay
FunctionCaptureDetectionColor ChangeChromogenProcedure	Polyclonal Rabbit AbMonoclonal Ab-GoldWhite to Red / PurpleColloidal Gold1. 1/15 dilution2. 150µl addition3. Ten min RT incubation4. Read visible results	Monoclonal AbMonoclonal Ab-HRPClear to BlueTMB1. 1/41 dilution2. 100µl addition3. 2 drops conjugate4. mix5. 60 min RT incubation6. Decant & Wash 5X7. 2 drops substrate8. 2 drops chromogen9. 10 min RT incubation10. Read visible or 450nm Abs.results	Polyclonal Guinea Pig AbMonoclonal Ab-Alk. Phos.White to PurpleUnknown1. 1/11 dilution andfiltration2. 3 drops conjugate3. 5 min RT incubation4. Pour through device andremove focuser5. Wash (fill)6. 3 drops substrate7. 2 min RT incubation8. Wash (fill)9. Read visible results
Interpretation	Pos/Neg/Invalid	Pos/Neg	Pos/Neg/Invalid
Performance vs Electron MicroscopySensitivitySpecificityCorrelation	93.1%95.8%94.4%	93.8%94.1%94.0%	93.8%90.8%92.4%
Performance vs Premier RotacloneSensitivitySpecificityCorrelation	97.7%100.0%98.8%	NANANA	98.4%95.0%96.8%

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510(k) Summary ImmunoCard STAT! Rotavirus

ﻟﻤﺴﺴﺴ

Additional Information/Non-clinical Test Results: B.

1. Sensitivity Limits: The sensitivity of the ImmunoCard STAT! Rotavirus is approximately 1.8-3.7 x 106 viral particles.
1. Reproducibility: Reproducibility of the ImmunoCard STAT! Rotavirus test was 100% on controls, negative and moderate positive stools, and 96% on low positive stools.
1. Fresh versus Frozen Stools: The data indicated rotavirus is stable in stool for at least three days when stored at 4°C or frozen at ≤-20°C.
1. Cross-Reactivity: Testing of the ImmunoCard STAT! Rotavirus with a panel of bacteria and viruses gave no false positive or false negative results.
1. Interfering Substances: Testing of the ImmunoCard STAT! Rotavirus with blood showed that high levels (≥33%) could affect flow, resulting in an occasional invalid test result. No effect from barium sulfate was observed.

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Image /page/3/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three swooping lines forming its body and wings. The eagle is positioned to the right of a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a sans-serif font. The text is arranged around the circle's perimeter, with "DEPARTMENT OF HEALTH & HUMAN SERVICES" at the top and "USA" at the bottom.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Allen D. Nickol, Ph.D. Director of Scientific and Regulatory Affairs * Meridian Diagnostics, Inc. 3471 River Hills Drive Cincinnati, Ohio 45244

AUG 20 1997

Re: K971585 Trade Name: ImmunoCard® STAT! Rotavirus Regulatory Class: I Product Code: LIQ Dated: June 30, 1997 Received: July 1, 1997

Dear Dr. Nickol:

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 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 Federai 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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Meridian Diagnostics, Inc. Cincinnati, OH 45244

)

C. Indications for Use Statement:

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: ImmunoCard® STAT! Rotavirus

Indications For Use: For use to detect the presence of rotavirus in stool specimens from patients with loose stools, diarrhea, gastroenteritis, or suspected to be infected with rotavirus.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Re R

Sign Off

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number. K971585

Prescription Use
(Per 21 CFR 801.109) √

Over-The-Counter Use (Optional Format 1-2-96)

Regulation Number and Section

§ 866.3405 Poliovirus serological reagents.

(a)
Identification. Poliovirus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to poliovirus in serum. Additionally, some of these reagents consist of poliovirus antisera conjugated with a fluorescent dye (immunofluorescent reagents) used to identify polioviruses from clinical specimens or from tissue culture isolates derived from clinical specimens. The identification aids in the diagnosis of poliomyelitis (polio) and provides epidemiological information on this disease. Poliomyelitis is an acute infectious disease which in its serious form affects the central nervous system resulting in atrophy (wasting away) of groups of muscles, ending in contraction and permanent deformity.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.