(111 days)
Not Found
No
The device description details a traditional immunogold assay with no mention of AI or ML components. The performance studies focus on standard analytical and clinical metrics for such assays.
No
This device is for in vitro diagnostic use, detecting rotavirus antigen to aid in diagnosis, not for treating a disease or condition.
Yes
The device is explicitly stated to "aid in the diagnosis of rotavirus associated gastroenteritis" and is used to "detect the presence of rotavirus in stool specimens from patients with loose stools, diarrhea, gastroenteritis, or suspected to be infected with rotavirus," which are all diagnostic functions.
No
The device description clearly outlines physical components like devices, controls, diluent, and pipets, indicating it is a hardware-based immunoassay kit, not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it is a "rapid in vitro qualitative procedure for the detection of rotavirus antigen in human stool." "In vitro" means "in glass" or "outside the body," which is a key characteristic of IVDs. It also states it's used to "aid in the diagnosis," which is a common purpose of IVDs.
- Device Description: The description details a test that analyzes a biological sample (human stool) outside of the body using chemical and biological reagents (antibodies, colloidal gold). This is the core function of an IVD.
- Anatomical Site: The sample is taken from "Stool specimens," which is a biological sample collected from the body for analysis.
- Performance Studies: The performance studies evaluate the device's ability to accurately detect the target analyte (rotavirus antigen) in the biological sample, comparing it to other diagnostic methods (Electron Microscopy, Premier Rotaclone). This is standard for evaluating IVD performance.
The information provided clearly indicates that this device is designed to perform a diagnostic test on a biological sample outside of the human body, which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
LIQ
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Stool
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
Comparison with Predicate Devices:
Performance vs Electron Microscopy: Sensitivity 93.1%, Specificity 95.8%, Correlation 94.4%
Performance vs Premier Rotaclone: Sensitivity 97.7%, Specificity 100.0%, Correlation 98.8%
Additional Information/Non-clinical Test Results:
- Sensitivity Limits: The sensitivity of the ImmunoCard STAT! Rotavirus is approximately 1.8-3.7 x 10^6 viral particles.
- Reproducibility: Reproducibility of the ImmunoCard STAT! Rotavirus test was 100% on controls, negative and moderate positive stools, and 96% on low positive stools.
- Fresh versus Frozen Stools: The data indicated rotavirus is stable in stool for at least three days when stored at 4 degrees C or frozen at less than or equal to -20 degrees C.
- Cross-Reactivity: Testing of the ImmunoCard STAT! Rotavirus with a panel of bacteria and viruses gave no false positive or false negative results.
- Interfering Substances: Testing of the ImmunoCard STAT! Rotavirus with blood showed that high levels (greater than or equal to 33%) could affect flow, resulting in an occasional invalid test result. No effect from barium sulfate was observed.
Key Metrics
Sensitivity, Specificity, Correlation
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
510(k) Summary ImmunoCard STAT! Rotavirus
ﻤﺴﯿﺴﯿﺪ
Meridian Diagnostics, Inc. Cincinnati, Ohio 45244
APPENDIX A - 510(k) Summary
A. Identification Information
AUG 20 1997
-
- 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
-
- 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
1
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 | Premier
Rotaclone | Abbott
Test Pack |
|---------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Detection of rotavirus in patient stool | | |
| Results | Qualitative | | |
| Technology | Immunoassay | | |
| Function
Capture
Detection
Color Change
Chromogen
Procedure | Polyclonal Rabbit Ab
Monoclonal Ab-Gold
White to Red / Purple
Colloidal Gold
- 1/15 dilution
- 150µl addition
- Ten min RT incubation
- Read visible results | Monoclonal Ab
Monoclonal Ab-HRP
Clear to Blue
TMB - 1/41 dilution
- 100µl addition
- 2 drops conjugate
- mix
- 60 min RT incubation
- Decant & Wash 5X
- 2 drops substrate
- 2 drops chromogen
- 10 min RT incubation
- Read visible or 450nm Abs.
results | Polyclonal Guinea Pig Ab
Monoclonal Ab-Alk. Phos.
White to Purple
Unknown - 1/11 dilution and
filtration - 3 drops conjugate
- 5 min RT incubation
- Pour through device and
remove focuser - Wash (fill)
- 3 drops substrate
- 2 min RT incubation
- Wash (fill)
- Read visible results |
| Interpretation | Pos/Neg/Invalid | Pos/Neg | Pos/Neg/Invalid |
| Performance vs Electron Microscopy
Sensitivity
Specificity
Correlation | 93.1%
95.8%
94.4% | 93.8%
94.1%
94.0% | 93.8%
90.8%
92.4% |
| Performance vs Premier Rotaclone
Sensitivity
Specificity
Correlation | 97.7%
100.0%
98.8% | NA
NA
NA | 98.4%
95.0%
96.8% |
2
510(k) Summary ImmunoCard STAT! Rotavirus
ﻟﻤﺴﺴﺴ
Additional Information/Non-clinical Test Results: B.
-
- Sensitivity Limits: The sensitivity of the ImmunoCard STAT! Rotavirus is approximately 1.8-3.7 x 106 viral particles.
-
- Reproducibility: Reproducibility of the ImmunoCard STAT! Rotavirus test was 100% on controls, negative and moderate positive stools, and 96% on low positive stools.
-
- 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.
-
- Cross-Reactivity: Testing of the ImmunoCard STAT! Rotavirus with a panel of bacteria and viruses gave no false positive or false negative results.
-
- 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.
3
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
5
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) √
1
OR
Over-The-Counter Use (Optional Format 1-2-96)