(188 days)
The IMAGEN™ Parainfluenza virus Group (Types 1, 2 and 3) is a qualitative direct immunofluorescence test for the presumptive detection and confirmation of parainfluenza virus type 1, 2 and 3 antigens in respiratory specimens (nasopharyngeal aspirates) from paediatric populations and in cell culture preparations.
The IMAGEN™ Parainfluenza virus Types 1. 2 and 3 is a qualitative direct immunofluorescence test for the presumptive detection and differentiation of parainfluenza virus type 1, 2 and 3 antigens respectively in respiratory specimens (nasopharyngeal aspirates) from paediatric populations and in cell culture preparations.
A negative result obtained following direct staining of nasopharyngeal aspirates should be considered presumptive until confirmed by culture.
IMAGEN™ Parainfluenza Virus Group (Types 1, 2 and 3) is for the detection and confirmation of the presence of Parainfluenza virus antigens in cell culture preparations and direct specimens (nasopharyngeal aspirates) from paediatric populations. A single reagent is provided which contains a mix of purified murine monoclonal antibodies specific to Parainfluenza virus types 1, 2 and 3, conjugated to fluorescein isothiocyanate (FITC).
IMAGEN™ Parainfluenza Virus Types 1, 2 and 3 is for the detection and differentiation of Parainfluenza virus type 1, 2 and 3 antigens respectively in cell culture preparations and direct specimens (nasopharyngeal aspirates) from paediatric populations. Three individual reagents are provided which each contain a purified murine monoclonal antibody specific to either Parainfluenza virus type 1, 2 or 3, conjugated to fluorescein isothiocyanate (FITC).
The technological characteristics of the IMAGEN ™ Parainfluenza Virus Group (Types 1, 2 and 3) and IMAGEN'''' Parainfluenza Virus Types 1, 2 and 3 differ from those of the Predicate Device in that they consist of directly FITC labelled type specific mouse monoclonal antibodies which are used in a one step direct immunofluorescence technique.
Here's an analysis of the provided text regarding the acceptance criteria and study for the DAKO IMAGEN™ Parainfluenza Virus diagnostic kits:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state pre-defined acceptance criteria (e.g., "The device must achieve a sensitivity of X% against the predicate device"). Instead, it presents the performance of the new device and compares it to a predicate device and viral isolation. Therefore, I will derive the implied acceptance criteria from the reported performance and the overall conclusion.
| Acceptance Criteria (Implied) | IMAGEN™ Parainfluenza Virus Group (Types 1, 2 and 3) Performance | IMAGEN™ Parainfluenza Virus Types 1, 2 and 3 Performance (Specific Types) |
|---|---|---|
| Against Predicate Device: | ||
| • High Correlation | 98.4% (125/127) | Type 1: 100% correlation, sensitivity, specificity |
| Type 2: 100% correlation, sensitivity, specificity | ||
| Type 3: 98.4% (125/127) correlation, 75% (3/4) sensitivity, 99.1% (122/123) specificity | ||
| • High Relative Sensitivity | 96.2% (25/26) | Type 1: 100% sensitivity |
| Type 2: 100% sensitivity | ||
| Type 3: 75% (3/4) sensitivity | ||
| • High Relative Specificity | 99.0% (100/101) | Type 1: 100% specificity |
| Type 2: 100% specificity | ||
| Type 3: 99.1% (122/123) specificity | ||
| Against Viral Isolation (Gold Standard): | ||
| • High Correlation | 97.6% (164/168) | Type 1: 100% correlation, sensitivity, specificity |
| Type 2: 100% correlation, sensitivity, specificity | ||
| Type 3: 97.6% (164/168) correlation, 91.6% (22/24) sensitivity, 98.6% (142/144) specificity | ||
| • High Relative Sensitivity | 97.9% (47/48) | Type 1: 100% sensitivity |
| Type 2: 100% sensitivity | ||
| Type 3: 91.6% (22/24) sensitivity | ||
| • High Relative Specificity | 97.5% (117/120) | Type 1: 100% specificity |
| Type 2: 100% specificity | ||
| Type 3: 98.6% (142/144) specificity | ||
| Overall Conclusion (as stated in the document) | The IMAGEN™ Tests will provide an accurate means of detecting Parainfluenza virus antigens in respiratory specimens. | The IMAGEN™ Tests will provide an accurate means of detecting Parainfluenza virus antigens in respiratory specimens. |
Study Proving Device Meets Criteria:
The "clinical performance characteristics" study described in the 510(k) summary is the study that proves the device meets the (implied) acceptance criteria. This study compared the IMAGEN™ Parainfluenza Virus kits against the Bartels Viral Respiratory Screening and Identification kit (Predicate Device) and viral isolation.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The IMAGEN™ Parainfluenza Virus Group (Types 1, 2 and 3) test and the IMAGEN™ Parainfluenza Virus Types 1, 2 and 3 test were both assessed on a total of 184 direct specimens.
- Data Provenance: The study was conducted in 3 routine diagnostic laboratories:
- 1 in the US
- 2 in the UK
- The data is retrospective/observational as it involves assessing specimens within routine diagnostic laboratories.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not specify the number of experts or their qualifications for establishing the ground truth.
- The ground truth for comparison was established by:
- The Predicate Device (Bartels Viral Respiratory Screening and Identification kit)
- Viral isolation (considered the gold standard for viral detection).
For viral isolation, it's generally understood that highly trained laboratory personnel (e.g., virologists, clinical microbiologists, medical technologists with specialized training) perform and interpret the results, but their specific "expert" qualifications, years of experience, or number are not detailed in this document.
4. Adjudication Method for the Test Set
The document does not describe an adjudication method for conflicting results. The comparisons are presented directly against the predicate device and viral isolation. It implies that if there were discrepancies between the new device and the predicate device, viral isolation was used as the definitive arbiter.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not explicitly described. This document pertains to the performance of an in vitro diagnostic (IVD) device (a lab test), not an imaging AI or a device requiring human reader interpretation in the context of improving diagnostic accuracy. The "readers" here would be the lab technicians performing the tests, but the study focuses on the performance of the reagents themselves, not a human-AI interaction.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, this was a standalone performance study of the diagnostic kit. The "algorithm" here refers to the immunofluorescence assay protocol itself, which is executed by laboratory personnel, but the performance metrics (sensitivity, specificity, correlation) are attributed to the kit's ability to detect the virus, independent of real-time human interpretation enhancement or human-in-the-loop decision making.
7. The Type of Ground Truth Used
Two types of ground truth were used:
- Predicate Device: The Bartels Viral Respiratory Screening and Identification kit.
- Viral Isolation: This is considered the definitive gold standard for confirming the presence of live virus and is often used as the ultimate ground truth in virology.
8. The Sample Size for the Training Set
The document does not mention a training set or any machine learning/AI development. This is a 510(k) submission for a diagnostic reagent kit, not an AI/ML medical device. Therefore, the concept of a "training set" as it relates to AI is not applicable here.
9. How the Ground Truth for the Training Set Was Established
As no training set was mentioned or implied (see point 8), this question is not applicable.
§ 866.3400 Parainfluenza virus serological reagents.
(a)
Identification. Parainfluenza virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to parainfluenza virus in serum. The identification aids in the diagnosis of parainfluenza virus infections and provides epidemiological information on diseases caused by these viruses. Parainfluenza viruses cause a variety of respiratory illnesses ranging from the common cold to pneumonia.(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 the limitations in § 866.9.