(58 days)
K/DEN: Not Found
API 20E, API NFT
No
The device description and performance studies focus on biochemical testing and database comparison, with no mention of AI or ML algorithms.
No
The device is described as an in-vitro diagnostic test for identifying microorganisms and does not claim to treat, mitigate, prevent, or cure any disease or condition.
Yes
Explanation: The Vitek GNI+ Card automates the identification of microorganisms from patient specimens, providing information crucial for diagnosing infections.
No
The device description explicitly states it is a "plastic card with thirty wells that contain 28 dehydrated biochemical broths, one negative control broth and one growth control broth," which are physical components.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "automated identification of microorganism... isolated from a patient specimen." This is a classic definition of an in vitro diagnostic device, as it's used to analyze a sample taken from a patient to provide information about their health (in this case, identifying the causative microorganism of an infection).
- Device Description: The device uses "dehydrated biochemical broths" that are "re-hydrated with a saline suspension of a pure culture isolated from a patient specimen." This describes a laboratory test performed on a biological sample outside of the body.
- Performance Studies: The performance studies involve testing "routine clinical isolates" from "fresh patient cultures." This further confirms its use in a clinical laboratory setting for diagnostic purposes.
Therefore, based on the provided information, the Vitek GNI+ Card clearly fits the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Vitek GNI+ Card is intended to be used in conjunction with the Vitek System for the automated identification of microorganism of the family Enterobacteriaceae. In addition, a select group of glucose non-fermenting gram-negative bacteria, and members of the family Vibrionaceae can be identified. In addition to the organisms currently claimed with the GNI Card, the GNI+ Card has added the following 13 new organism claims:
- Aeromanas veronii biovar veronii Budvicia aquatica Burkholdenia mallei CDC Group EO-2 Chromobacterium violaceum Edwardsiella hoshinae Klebsiella ornithinolytica Moellerella wisconsensis Rahnella aquatilis Shigella boydii/flexneri Sphingobacterium spiritivorum Sphingobacterium thalpophilum Yokenella regensburgei (Koserella trabulsii)
Product codes
Not Found
Device Description
The GNI+ Card consists of a plastic card with thirty wells that contain 28 dehydrated biochemical broths, one negative control broth and one growth control broth. The broths are re-hydrated with a saline suspension of a pure culture isolated from a patient specimen. The GNI+ Card performs a variety of conventional and non-conventional biochemical tests that are based on established biochemical methods. Organism identification usually requires between 2-12 hours of incubation on the automated Vitek System.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
A panel of 2974 strains were used to develop the GNI + database. These organism were well characterized, having been previously previously identified by the GNI Card, API strips and/or conventional biochemicals.
Description of the test set, sample size, data source, and annotation protocol
A panel of 106 challenge organisms bioMérieux Vitek which cover the GNT+ card's performance claims, were tested. The challenge organisms were different isolates than those used to develop the database. Extremely rare or pathogenic organisms were excluded from this challenge set. A minimum of 130 routine clinical isolates were tested. These isolates were from fresh patient cultures as they were randomly submitted to the laboratory. Thirty to fifty isolates from the investigator's stock collection were tested in addition to the 130 clinical isolates.
Summary of Performance Studies
Non Clinical Development Trials: A panel of 2974 strains were used to develop the GNI + database. The GNI + Card correctly identified 96.9% of the tests run.
Clinical Trials: Three clinical sites conducted the trials. The performance claims of the GNI+ card were validated by directly comparing to the current Vitek GNI Card. Discrepancies between the GNI+ and the current GNI were resolved by the API 20E (fermenters) or the API NFT (non-fermenters). Further discrepancies and also any sample that was identified by the GNI+ card as a species not claimed by the reference methodology(ies) was confirmed with conventional biochemical testing.
The GNI+ Card identified the challenge set provided by bioMérieux Vitek correctly 94.7% of the time.
Key Metrics
GNI + Card correctly identified 96.9% of the tests run (Non-Clinical Development Trials).
The GNI+ Card identified the challenge set provided by bioMérieux Vitek correctly 94.7% of the time (Clinical Trials).
Overall correlation of GNI+ compared to GNI was 97.4% (Clinical Trials and Conclusions).
Predicate Device(s)
bioMérieux Vitek, Inc. Gram Negative Identification (GNI) Card
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 866.2660 Microorganism differentiation and identification device.
(a)
Identification. A microorganism differentiation and identification device is a device intended for medical purposes that consists of one or more components, such as differential culture media, biochemical reagents, and paper discs or paper strips impregnated with test reagents, that are usually contained in individual compartments and used to differentiate and identify selected microorganisms. The device aids in the diagnosis of disease.(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 Statement
AUG 30 1992
| Company Name: | bioMérieux Vitek, Inc.
595 Anglum Drive
Hazelwood, MO 63042 |
|--------------------------------|----------------------------------------------------------------------|
| Contact Person: | David K Broadway |
| | Phone: (314) 731-7415 |
| | Fax: (314) 731-7415 |
| Date Prepared: | May 30, 1996 |
| Device Name: | Gram Negative Identification Plus (GNI+) Card |
| Classification | Automated Microorganism Differentiation
and Identification Device |
| | Class I |
| Substantial Equivalence Claim: | bioMérieux Vitek, Inc.
Gram Negative Identification (GNI) Card |
Device Description:
The GNI+ Card consists of a plastic card with thirty wells that contain 28 dehydrated biochemical broths, one negative control broth and one growth control broth. The broths are re-hydrated with a saline suspension of a pure culture isolated from a patient specimen. The GNI+ Card performs a variety of conventional and non-conventional biochemical tests that are based on established biochemical methods. Organism identification usually requires between 2-12 hours of incubation on the automated Vitek System.
Intended Use:
The Vitek GNI+ Card is intended to be used in conjunction with the Vitek System for the automated identification of microorganism of the family Enterobacteriaceae. In addition, a select group of glucose non-fermenting gram-negative bacteria, and members of the family Vibrionaceae can be identified. In addition to the organisms currently claimed with the GNI Card, the GNI+ Card has added the following 13 new organism claims:
- Aeromanas veronii biovar veronii Budvicia aquatica Burkholdenia mallei CDC Group EO-2 Chromobacterium violaceum Edwardsiella hoshinae Klebsiella ornithinolytica Moellerella wisconsensis Rahnella aquatilis Shigella boydii/flexneri Sphingobacterium spiritivorum Sphingobacterium thalpophilum Yokenella regensburgei (Koserella trabulsii)
1
Technological Characterisitics
The GNI + Card maintains the same technological characteristics as GNI, i.e., conventional and nonconventional biochemical tests that are selectively metabolized by bacteria, resulting in reactivity biopatterns that may be photometrically read and analyzed by the automated Vitek System .
Non Clinical Development Trials
A panel of 2974 strains were used to develop the GNI + database. These organism were well characterized, having been previously previously identified by the GNI Card, API strips and/or conventional biochemicals. The GNI + Card correctly identified 96.9% of the tests run.
Clinical Trials
Three clinical sites conducted the trials.
Trial Design
The performance claims of the GNI+ card were validated by directly comparing to the current Vitek GNI Card. Discrepancies between the GNI+ and the current GNI were resolved by the API 20E (fermenters) or the API NFT (non-fermenters). Further discrepancies and also any sample that was identified by the GNI+ card as a species not claimed by the reference methodology(ies) was confirmed with conventional biochemical testing.
A panel of 106 challenge organisms bioMérieux Vitek which cover the GNT+ card's performance claims, were tested. The challenge organisms were different isolates than those used to develop the database. Extremely rare or pathogenic organisms were excluded from this challenge set. A minimum of 130 routine clinical isolates were tested. These isolates were from fresh patient cultures as they were randomly submitted to the laboratory. Thirty to fifty isolates from the investigator's stock collection were tested in addition to the 130 clinical isolates. The GNI+ Card identified the challenge set provided by bioMérieux Vitek correctly 94.7% of the time. Overall correlation of GNI+ compared to GNI was 97.4%
Software Testing
GNI+ software analysis rules were tested extensively in-house and were also run at the clinical trial sites. A detailed protocol was established to challenge the performance of the GNI+ card based on the software specification. This software was designed, validated and tested according to established written procedures.
Safety and Effectiveness Issues
The GNI+ data validates that the performance characteristics are and effective. No adverse discrepancies were noted in the comparison studies. When used according to the package insert directions, the GNI + Card will perform as claimed.
Conclusions
The modifications to the database in order to incorporate the 13 new strains does not affect the safety or effectiveness of the GNT+ card, as demonstrated by the data included in this premarket notification. Overall correlation of GNI + compared to GNI was 97.4%