(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.
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Image /page/0/Picture/1 description: The image shows the logo for Dako. The logo consists of a square with a white border and a black background. Inside the square is a white teardrop shape. To the right of the square is the word "DAKO" in large, bold, black letters.
SEP 2 8 1998
ITEM 3
510(k) SUMMARY
| Submitter's Name: | DAKO Limited |
|---|---|
| Address: | Denmark House,Angel Drove, Ely,Cambridgeshire, CB7 4ET |
| Phone: | (353) 669911 |
| Fax: | (353) 668989 |
| Contact Name: | Dr. Ron Newstead, Quality Manager |
| Date of preparation: | 17th September 1998 |
| Trade Name(s): | IMAGEN™ Parainfluenza Virus Group (Types 1, 2 and 3)- Product Code (K6103)IMAGEN™ Parainfluenza Virus Types 1, 2 and 3- Product Code (K6104) |
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 clinical performance of The IMAGEN™ Parainfluenza Virus Group (Types 1, 2 and 3) and IMAGEN™ Parainfluenza Virus Types 1, 2 and 3 was compared with that achieved with the Parainfluenza typing reagents within the Bartels Viral Respiratory Screening and Identification kit (Predicate Device).
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. The Predicate Device consists of individual type-specific mouse monoclonal antibodies which are used in a
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Image /page/1/Picture/0 description: The image shows the logo for Dako. The logo consists of a square with a water drop inside on the left and the word "DAKO" on the right. The logo is black and white and appears to be slightly distressed.
two-step indirect immunofluorescence assay with a separate secondary conjugate specific for mouse monoclonal antibodies and conjugated to FITC.
The clinical performance characteristics of the IMAGEN 100 Parainfluenza virus Group (Types 1,2 and 3) and the IMAGEN™ Parainfluenza virus Types 1, 2 and 3 tests were assessed in 3 routine diagnostic laboratories (1 in the US and 2 in the UK). Their performance was compared with the above named Predicate Device, and viral isolation.
The IMAGEN™ Parainfluenza virus Group (Types 1, 2 and 3) test was assessed on a total of 184 direct specimens at the US trial centre and showed a correlation of 98.4% (125/127) against the Predicate Device and 97.6% (164/168) against viral isolation. The relative sensitivity and specificity of the IMAGEN "" Parainfluenza virus Group (Types 1,2 and 3) test was 96.2% (25/26) and 99.0% (100/101) respectively against the Predicate Device and 97.9% (47/48) and 97.5% (117/120) respectively against viral isolation.
The IMAGEN™ Parainfluenza virus Types 1, 2 and 3 test was assessed on the same 184 direct specimens. Both the IMAGEN™ Parainfluenza virus Type 1 and Type 2 reagents showed a correlation, sensitivity and specificity of 100% against the Predicate Device. The IMAGEN™ Parainfluenza virus Type 3 reagent gave a correlation of 98.4% (125/127), sensitivity of 75% (3/4) and specificity of 99.1% (122/123) against the Predicate Device.
When compared with viral isolation both the IMAGEN™ Parainfluenza virus Type 1 and Type 2 reagents gave 100 % correlation, sensitivity and specificity. The IMAGEN™ Parainfluenza virus Type 3 reagent gave a correlation of 97.6% (164/168), sensitivity of 91.6% (22/24) and specificity of 98.6% (142/144).
The conclusions drawn from these clinical tests are that the comparison of the results obtained with the IMAGENTM Parainfluenza virus Group (Types 1, 2 and 3) and IMAGEN'™ Parainfluenza virus Types 1, 2 and 3 tests and the Predicate Device demonstrate that the IMAGEN™ Tests will provide an accurate means of detecting Parainfluenza virus antigens in respiratory specimens.
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# SEP 28 1998
Ron Newstead Quality Manager Dako Diagnostics Ltd. Denmark House, Angel Drove Ely Cambridgeshire United Kingdom
Re: [K981226](https://510k.innolitics.com/search/K981226)
> Trade Name: Imagen™ Parainfluenza Virus Group (Types 1, 2 and 3) and Imagen™ Parainfluenza Virus Types 1, 2 and 3 Regulatory Class: I Product Code: GOP Dated: July 20, 1998 Received: July 23, 1998
Dear Mr. Newstead:
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 legally marketed predicate 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.
DEPARTMENT OF HEALTH & HUMAN SERVICES
USA
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
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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 Autman
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
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Image /page/4/Picture/0 description: The image shows the logo for Dako, a company that specializes in cancer diagnostics. The logo consists of a stylized symbol on the left and the word "DAKO" in bold, sans-serif letters on the right. The symbol appears to be a stylized representation of a cell or other biological structure. The logo is simple and modern, and it is likely used on the company's website, products, and marketing materials.
#### ITEM 5
#### INDICATIONS FOR USE STATEMENT
I age 1 of 1
### 510(k) Number: [K981266](https://510k.innolitics.com/search/K981266) (Supplement to [K962037](https://510k.innolitics.com/search/K962037))
# Devices Name: IMAGEN™ PARAINFLUENZA VIRUS GROUP (TYPES 1, 2 AND 3) IMAGEN™ PARAINFLUENZA VIRUS TYPES 1, 2 AND 3
Indications for Use: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.
Signature:
Date:
18 September 1998
Axel Johannsson Managing Director
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Concurrence of CDRH, Office of Device Evaluation (ODE)
ical Laboratory Devices Number
PRESCRIPTION USE X
§ 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.