(188 days)
Bartels Viral Respiratory Screening and Identification kit
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No
The device description and performance studies focus on a direct immunofluorescence assay using monoclonal antibodies. There is no mention of AI, ML, image processing for interpretation, or any computational analysis beyond standard laboratory procedures.
No
The device is a diagnostic test for detecting Parainfluenza virus antigens, not a therapeutic device designed to treat or alleviate a disease.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is for "presumptive detection and confirmation of parainfluenza virus type 1, 2 and 3 antigens," which directly falls under the definition of a diagnostic device. The "Intended User / Care Setting" also specifies "Routine diagnostic laboratories."
No
The device description clearly states it is a qualitative direct immunofluorescence test using reagents (purified murine monoclonal antibodies conjugated to fluorescein isothiocyanate). This indicates a physical kit or components are involved, not just software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for the "presumptive detection and confirmation of parainfluenza virus type 1, 2 and 3 antigens in respiratory specimens... and in cell culture preparations." This indicates that the device is used to examine specimens derived from the human body to provide information for diagnostic purposes.
- Device Description: The description details the reagents used to detect the presence of specific antigens in biological samples. This aligns with the nature of IVD devices.
- Performance Studies: The document includes performance studies comparing the device to a predicate device and viral isolation, which are standard practices for evaluating the performance of IVD tests.
- Key Metrics: The inclusion of metrics like sensitivity and specificity are crucial for assessing the diagnostic accuracy of an IVD.
- Predicate Device: The mention of a "Predicate Device" (Bartels Viral Respiratory Screening and Identification kit) strongly suggests that this device is being compared to an existing, legally marketed IVD.
All these elements point to the device being an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
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.
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.
Product codes (comma separated list FDA assigned to the subject device)
K6103, K6104, GOP
Device Description
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. The Predicate Device consists of individual type-specific mouse monoclonal antibodies which are used in a two-step indirect immunofluorescence assay with a separate secondary conjugate specific for mouse monoclonal antibodies and conjugated to FITC.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Respiratory specimens (nasopharyngeal aspirates)
Indicated Patient Age Range
Paediatric populations
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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.
The IMAGEN™ Parainfluenza virus Types 1, 2 and 3 test was assessed on the same 184 direct specimens.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 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 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) 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) against viral isolation.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
IMAGEN™ Parainfluenza virus Group (Types 1, 2 and 3) test:
- Against Predicate Device: relative sensitivity of 96.2% (25/26) and specificity of 99.0% (100/101).
- Against viral isolation: relative sensitivity of 97.9% (47/48) and specificity of 97.5% (117/120).
IMAGEN™ Parainfluenza virus Type 1 and Type 2 reagents:
- Against Predicate Device: sensitivity and specificity of 100%.
- Against viral isolation: sensitivity and specificity of 100%.
IMAGEN™ Parainfluenza virus Type 3 reagent:
- Against Predicate Device: sensitivity of 75% (3/4) and specificity of 99.1% (122/123).
- Against viral isolation: sensitivity of 91.6% (22/24) and specificity of 98.6% (142/144).
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.
Bartels Viral Respiratory Screening and Identification kit
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.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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
1
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.
**2**
# 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
**3**
### 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
**4**
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