(59 days)
Cambridge Biotech Rotaclone Assay
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No
The summary describes a standard immunoassay performed on an automated instrument, with no mention of AI, ML, or related concepts.
No
The device is used for diagnosing rotavirus antigen in stool specimens, which aids in the diagnosis of nonbacterial gastroenteritis. It does not provide any therapeutic benefit or treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device "is intended as an aid in the diagnosis of acute nonbacterial gastroenteritis." This directly indicates its diagnostic purpose.
No
The device description explicitly states it is an enzyme-linked fluorescent immunoassay (ELFA) performed in an automated instrument and includes physical components like a Solid Phase Receptacle (SPR), Reagent Strip, and control bottles. This indicates it is a hardware-based diagnostic assay kit, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the assay is for the "qualitative detection of rotavirus antigen in stool specimens" and is "intended as an aid in the diagnosis of acute nonbacterial gastroenteritis." This clearly indicates that the device is used to examine specimens derived from the human body (stool) to provide information for diagnostic purposes.
- Device Description: The description details a laboratory test that uses reagents and an automated instrument to analyze a biological sample (stool). This is characteristic of an in vitro diagnostic device.
- Performance Studies: The document includes a "Summary of Performance Studies" which details the evaluation of the device's performance in detecting rotavirus in stool samples, including comparisons to other methods (EIA, Electron Microscopy). This type of performance evaluation is standard for IVDs.
- Key Metrics: The "Key Metrics" section provides sensitivity, specificity, and overall agreement values, which are common performance indicators for diagnostic tests.
- Predicate Device: The mention of a "Predicate Device" (Cambridge Biotech Rotaclone Assay) is typical in regulatory submissions for IVDs, where a new device is compared to an already cleared device.
All these elements strongly indicate that the VIDAS Rotavirus (RTV) Assay is an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The VIDAS Rotavirus (RTV) Assay is for the qualitative detection of rotavirus antigen in stool specimens. It is intended as an aid in the diagnosis of acute nonbacterial gastroenteritis.
Product codes
LIQ
Device Description
The VIDAS Rotavirus (RTV) Assay is an enzyme-linked fluorescent immunoassay (ELFA) performed in an automated VIDAS (Vitek ImmunoDiagnositic Assay System) instrument. All assay steps and the assay temperature are controlled by the instrument.
The VIDAS Rotavirus Assay contains a pipette tip-like disposable device, the Solid Phase Receptacle (SPR), a Reagent Strip, 1 Bottle of Standard, 1 Bottle of Positive Control, and 1 Bottle of Negative Control. The Kit contains a sufficient number of SPR's and Strips to perform 60 Tests.
The SPR serves as the solid phase, as well as, the pipettor for the assay. The SPR is coated with rabbit anti-rotavirus antibodies. The Strip contains the reagents necessary to perform the assay, as well as, a sample well for placement of the specimen. Each RTV Assay requires one RTV Reagent Strip and one RTV SPR.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
stool specimens
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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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
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- False Positive Results: In studies comparing the VIDAS RTV Assay to one commercially available EIA there were 8 false positive samples. This results in a relative specificity of 95.8% with overall agreement of 94.6%. Comparing the VIDAS RTV to a second EIA resulted in 8 false positives. This results in a relative specificity of 95.7% with an overall agreement of 92.4% In a study comparing VIDAS RTV Assay to Electron Microscopy, there were no false positive samples.
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- False Negative Results: In studies comparing the VIDAS RTV Assay to one commercially available EIA there were 9 false negative samples. This results in a sensitivity of 92.7% with overall agreement of 94.6%. Comparing the VIDAS RTV to a second EIA resulted in 16 false negative samples. This results in a relative sensitivity of 87.8% with an overall agreement of 92.4%. In a study comparing the VIDAS RTV Assay to Electron Microscopy, there were 3 false negative results this results in a sensitivity of 95.7% with overall agreement of 97.0%.
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- Thirteen discrepant samples from the VIDAS vs. EIA studies were further tested with EM. Of the 13 discrepant results 4 resolved positive and 4 resolved negative in agreement with VIDAS RTV. Three specimens were VIDAS positive and EIA negative, confirmed negative. One specimen was VIDAS negative and EIA positive, confirmed positive. One discrepant result was not tested. The overall agreement of all samples is 94.8%.
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- Equivocal results: In the studies done to support the VIDAS RTV Assay performance claims, there were 5 equivocal results when following the package insert instructions.
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- Invalid results: In the studies done to support the VIDAS RTV Assay performance claims there were no invalid results.
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- Cross-reactivity and interference: A panel of approximately 50 microorganisms representing normal enteric flora or common enteric pathogens was tested in the VIDAS RTV Assay. No cross-reactivity or interference was observed with the organisms tested.
-
- Precision: In the studies done to support the VIDAS RTV Assay performance claims, the intra-assay precision testing showed coefficients of variation of less than 10%. The inter-assay precision testing gave coefficients of variation of less than 10%.
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- Assay specificity is conferred by the use of two antibodies. The rotavirus antigen is captured on the SPR by a polyclonal anti-rotavirus VP6 antibody, and the detector antibody conjugate is composed of a mouse monoclonal anti-rotavirus VP6 antibody.
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- Limit of Detection: The limit of detection is defined as the concentration of organism yielding a test value of greater than the negative threshold. The results of testing known concentrations of rotavirus antigen (quantitated via EM) in the VIDAS RTV Assay showed the limit of detection to be approximately 3.16 x 102 VP/mL in formed stool: 6.28 x 102 VP/mL in semisolid stool; and 1.44 x 105 VP/mL in liquid stool.
Key Metrics
Relative specificity of 95.8% with overall agreement of 94.6% (vs. EIA 1)
Relative specificity of 95.7% with an overall agreement of 92.4% (vs. EIA 2)
Sensitivity of 92.7% with overall agreement of 94.6% (vs. EIA 1)
Relative sensitivity of 87.8% with an overall agreement of 92.4% (vs. EIA 2)
Sensitivity of 95.7% with overall agreement of 97.0% (vs. Electron Microscopy)
Overall agreement of all samples is 94.8%
Intra-assay precision testing showed coefficients of variation of less than 10%.
Inter-assay precision testing gave coefficients of variation of less than 10%.
Limit of detection: approximately 3.16 x 102 VP/mL in formed stool; 6.28 x 102 VP/mL in semisolid stool; and 1.44 x 105 VP/mL in liquid stool.
Predicate Device(s)
Cambridge Biotech Rotaclone Assay
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
Image /page/0/Picture/0 description: The image shows a sequence of handwritten digits and letters, which appear to be 'K412895'. The characters are written in a simple, clear style, with varying stroke thicknesses. The digits are easily readable, and the letters are distinguishable.
Image /page/0/Picture/1 description: The image shows the logo for bioMérieux. The logo consists of a stylized globe-like symbol above the company name. The globe is divided into two halves, one with horizontal lines and the other with a textured, dotted pattern. The text "bioMérieux" is written in a bold, sans-serif font below the globe symbol.
OCT - 3 1997
J.1 510(k) Summary
| Submitter: | Terry McGovern
bioMérieux Vitek, Inc.
1022 Hingham St.
Rockland, MA 02370
(617) 871-4442 |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date: | August 1, 1997 |
| Device: | VIDAS Rotavirus (RTV) Assay |
| Classification Name: | Enzyme Linked Immunoabsorbent Assay, Rotavirus (83LIQ) |
| Predicate Device: | Cambridge Biotech Rotaclone Assay |
| Intended Use: | The VIDAS Rotavirus (RTV) Assay is for the qualitative detection of rotavirus antigen in stool specimens. It is intended as an aid in the diagnosis of acute nonbacterial gastroenteritis. |
Device Description:
The VIDAS Rotavirus (RTV) Assay is an enzyme-linked fluorescent immunoassay (ELFA) performed in an automated VIDAS (Vitek ImmunoDiagnositic Assay System) instrument. All assay steps and the assay temperature are controlled by the instrument.
The VIDAS Rotavirus Assay contains a pipette tip-like disposable device, the Solid Phase Receptacle (SPR), a Reagent Strip, 1 Bottle of Standard, 1 Bottle of Positive Control, and 1 Bottle of Negative Control. The Kit contains a sufficient number of SPR's and Strips to perform 60 Tests.
The SPR serves as the solid phase, as well as, the pipettor for the assay. The SPR is coated with rabbit anti-rotavirus antibodies. The Strip contains the reagents necessary to perform the assay, as well as, a sample well for placement of the specimen. Each RTV Assay requires one RTV Reagent Strip and one RTV SPR.
Synopsis of Test Methods and Results
bioMérieux Vitek, Inc. has determined that the proposed change in labeling claims will not impact the safety and effectiveness of the VIDAS Rotavirus Assay. Below please find a synopsis of test methods used to verify this:
1
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- False Positive Results: In studies comparing the VIDAS RTV Assay to one commercially available EIA there were 8 false positive samples. This results in a relative specificity of 95.8% with overall agreement of 94.6%. Comparing the VIDAS RTV to a second EIA resulted in 8 false positives. This results in a relative specificity of 95.7% with an overall agreement of 92.4% In a study comparing VIDAS RTV Assay to Electron Microscopy, there were no false positive samples.
-
- False Negative Results: In studies comparing the VIDAS RTV Assay to one commercially available EIA there were 9 false negative samples. This results in a sensitivity of 92.7% with overall agreement of 94.6%. Comparing the VIDAS RTV to a second EIA resulted in 16 false negative samples. This results in a relative sensitivity of 87.8% with an overall agreement of 92.4%. In a study comparing the VIDAS RTV Assay to Electron Microscopy, there were 3 false negative results this results in a sensitivity of 95.7% with overall agreement of 97.0%.
-
- Thirteen discrepant samples from the VIDAS vs. EIA studies were further tested with EM. Of the 13 discrepant results 4 resolved positive and 4 resolved negative in agreement with VIDAS RTV. Three specimens were VIDAS positive and EIA negative, confirmed negative. One specimen was VIDAS negative and EIA positive, confirmed positive. One discrepant result was not tested. The overall agreement of all samples is 94.8%.
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- Equivocal results: In the studies done to support the VIDAS RTV Assay performance claims, there were 5 equivocal results when following the package insert instructions.
-
- Invalid results: In the studies done to support the VIDAS RTV Assay performance claims there were no invalid results.
-
- Cross-reactivity and interference: A panel of approximately 50 microorganisms representing normal enteric flora or common enteric pathogens was tested in the VIDAS RTV Assay. No cross-reactivity or interference was observed with the organisms tested.
-
- Precision: In the studies done to support the VIDAS RTV Assay performance claims, the intra-assay precision testing showed coefficients of variation of less than 10%. The inter-assay precision testing gave coefficients of variation of less than 10%.
-
- Assay specificity is conferred by the use of two antibodies. The rotavirus antigen is captured on the SPR by a polyclonal anti-rotavirus VP6 antibody, and the detector antibody conjugate is composed of a mouse monoclonal anti-rotavirus VP6 antibody.
-
- Limit of Detection: The limit of detection is defined as the concentration of organism yielding a test value of greater than the negative threshold. The results of testing known concentrations of rotavirus antigen (quantitated via EM) in the VIDAS RTV Assay showed the limit of detection to be approximately 3.16 x 102 VP/mL in formed stool: 6.28 x 102 VP/mL in semisolid stool; and 1.44 x 105 VP/mL in liquid stool.
The VIDAS RTV Assay must be used according to the package insert instructions when testing stool specimens for the presence of the rotavirus antigen. Additional information and reference may be found in the package insert.
2
Image /page/2/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 lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
OCT - 3 1997
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Terry McGovern · Manager, Quality Assurance/Regulatory Affairs bioMerieux Vitek, Inc. 1022 Hingham Street Rockland, MA 02370
Re: K972895
Trade Name: VIDAS Rotavirus (RTV) Assay Regulatory Class: I Product Code: LIQ Dated: August 1, 1997 Received: August 5, 1997
Dear Ms. McGovern:
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 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
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 (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Steven Butman
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
4
510(k) Number (if known):
Device Name: VIDAS Rotavirus Assay -------------------------------------------------------------------------------------------------------------------------------------------
Indications for Use:
ﻧﻤﺴﻴﺴﻪ
The VIDAS Rotavirus (RTV) assay is for the qualitative detection of rotavirus antigen in stool specimens. It is intended as an aid in the diagnosis of acute nonbacterial gastroenteritis.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Jean Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K972895
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