(77 days)
MicroScan® Rapid Gram-Negative Identification Type 2 Panel, API 20E System
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No
The summary describes a traditional biochemical identification system and its performance compared to predicate devices, with no mention of AI, ML, image processing, or any other indicators of AI/ML technology.
No.
The device is used for rapid identification of bacteria, which is a diagnostic purpose, not a therapeutic one.
Yes
This device is designed for "Rapid identification of non-fastidious aerobic and facultatively anaerobic gram-negative bacilli from human clinical specimens," which falls under the definition of diagnosing infectious agents from patient samples.
No
The description focuses on a "panel" and "isolates," suggesting a physical component (like a test kit or plate) is involved in the identification process, not just software. The performance studies also describe testing with "isolates" and "biochemical test results," further indicating a hardware or reagent component.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Rapid identification of non-fastidious aerobic and facultatively anacrobic gram-negative bacilli from human clinical specimens." This clearly indicates the device is used to analyze samples taken from the human body (in vitro) to provide diagnostic information (identification of bacteria).
- Anatomical Site: The mention of "human clinical specimens" reinforces that the device is used with samples from humans.
- Performance Studies: The description of efficacy and reproducibility testing using "fresh and stock gram-negative isolates at two (2) external sites" and comparison with other identification systems (API 20E System) is typical for the validation of an IVD device.
- Predicate Device(s): The listing of predicate devices like "MicroScan® Rapid Gram-Negative Identification Type 2 Panel" and "API 20E System" further confirms that this device falls within the category of IVDs used for microbial identification.
The core function of the device is to perform a test on a biological sample (clinical specimen) outside of the body to aid in diagnosis or identification, which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Rapid identification of non-fastidious aerobic and facultatively anacrobic gram-negative bacilli from human clinical specimens
Product codes
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Device Description
The proposed MicroScan Rapid Gram-Negative Identification Panel (referred to as the MicroScan RNID Type 3 panel) is substantially equivalent in intended use, technology, and methodology to the current MicroScan® Rapid Gram-Negative Identification Type 2 Panel and is subscantially equivalent to the API 20E System with regard to performance.
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
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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
Efficacy testing was conducted with a total of 405 fresh and stock gram-negative isolates at two (2) external sites. MicroScan Rapid Gram-Negative Identifications were compared with API 207. System identifications. Isolates meeting a pro-defined criteria wore cither repeated and/or were arbitrated using conventional tube methodologies.
Reproducibility testing with the MicroScan" Rapid Gram-Negative Identification Type 3 Panel (RND) was comprised of 15 stock isolates tested at two (2) external sites and at MicroScan. Reproducibility was evaluated using individual biochemical test results, biotype frequencies, and overall identification performance.
Quality control (QC) testing with the MicroScan Rapid Gram-Negative Idcritification Type 3 Panel (RNID) was conducted with cight (8) strains and a sallne blank. Quality control (QC) testing was performed on the API 20E System at the clinical trial sites according to the API 20E procedure manual.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Efficacy testing compared MicroScan Rapid Gram-Negative Identifications with API 20E System identifications. Overall the MicroScan RNID Type 3 panel demonstrated a combined final agreement (percent at the species level, high and low probabilities) of 97.1% (393/405) when compared with API 20E System identifications supplementional lube methodologics. There was only one (1) Very Rare Biolype (VRB) result.
Reproducibility testing showed that the MicroScan RNID Type 3 panel gave results which were > 95% in agreement with expected results.
The QC performance was acceptable for both systems during the clinical trial. The four (4) struins recommended for routine user (customer) OC for the MicroScan RNID Type 3 pancl provide adequate coverage to vorily that the panel is performing as expected during routine use (c.g. > 95% aercement).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Overall the MicroScan RNID Type 3 panel demonstrated a combined final agreement (percent at the species level, high and low probabilities) of 97.1% (393/405) when compared with API 20E System identifications supplementional lube methodologics.
Reproducibility was > 95% in agreement with expected results.
QC performance was > 95% agreement.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
MicroScan® Rapid Gram-Negative Identification Type 2 Panel, API 20E System
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
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Page 1 of 2 510(k) Summary - Attachment 1
DADE INTERNATIONAL
95% in agreement with expected results.
510K-SUM.DOC
1
Dade MicroScan Inc. May 28, 1996 MicroScan® Rapid Gram-Negative Identification Type 3 Pancl
Quality control (QC) testing with the MicroScan Rapid Gram-Negative Idcritification Type 3 Panel (RNID) was conducted with cight (8) strains and a sallne blank. Quality control (QC) testing was performed on the API 20E System at the clinical trial sites according to the API 20E procedure manual. The QC performance was acceptable for both systems during the clinical trial. The four (4) struins recommended for routine user (customer) OC for the MicroScan RNID Type 3 pancl provide adequate coverage to vorily that the panel is performing as expected during routine use (c.g. > 95% aercement). User OC recommendations for user QC as described by NCCLS Document M7-A3 (Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerohically, Ed.3; Approved Standard. Pennsylvania, NCCLS, December 1993).
We therefore believe that the MicroScan® Rapid Gram-Negative Identification Type 3 Panci (RNID) gives appropriate rapid identifications with non-fastidious aerobic and facultatively anacrobic gram-negative bacilli from human clinical spocimens.