(179 days)
Quidel CONCISE® PLUS™ MONO
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No
The device description and performance studies describe a rapid immunoassay based on antibody detection, with no mention of AI or ML technologies.
No.
The device is used for diagnosis of infectious mononucleosis, not for treatment.
Yes
The "Intended Use / Indications for Use" states that the device is "an aid in the diagnosis of acute infectious mononucleosis."
No
The device description clearly states it is a "Rapid membrane based immunoassay," which is a physical test kit, not software.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "The qualitative detection of human IgM antibodies to heterophile antigen in serum, plasma or whole blood as an aid in the diagnosis of acute infectious mononucleosis". This describes a test performed in vitro (outside the body) on biological specimens (serum, plasma, whole blood) to provide information for diagnosis.
- Device Description: The description details a "Rapid membrane based immunoassay for the qualitative detection of human IgM antibodies to heterophile antigen". This is a common type of in vitro diagnostic test.
- Specimen Types: The device uses serum, plasma, or whole blood, which are typical biological specimens used in in vitro diagnostic testing.
- Care Setting: The intended use in "physician's office laboratory and the clinical laboratory" further supports its use in a laboratory setting for diagnostic purposes.
The definition of an IVD is a medical device that is used to examine specimens taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. This device clearly fits that definition.
N/A
Intended Use / Indications for Use
The qualitative detection of human IgM antibodies to heterophile antigen in serum, plasma or whole blood as an aid in the diagnosis of acute infectious mononucleosis for use in the physician's office laboratory and the clinical laboratory.
Product codes
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Device Description
Rapid membrane based immunoassay for the qualitative detection of human IgM antibodies to heterophile antigen using mouse monoclonal anti-IgM antibodies and heterophile antigen from bovine red blood cells.
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
physician's office laboratory and the clinical laboratory.
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
A multicenter clinical study was performed in three physician's office laboratories, POL, (including two university student health clinical laboratory. The Genzyme Diagnostics Infectious Mono Test was provided to the sites. Each site also used the legally marketed Quidel Concise® Plus™ Mono Test. The Quidel test is marketed for laboratory and professional use.
The clinical laboratory performed the Genzyme and Quidel tests on serum and plasma specimens submitted for infectious mononucleosis. The university student health centers tested whole blood and plasma from students presenting with symptoms consistent with a diagnosis of infectious mononucleosis. A total of 480 serum, plasma and whole blood specimens were tested and compared with the reference method.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
A multicenter clinical study was performed in three physician's office laboratories (POL), including two university student health clinical laboratories. A total of 480 serum, plasma and whole blood specimens were tested. The results demonstrate that the Genzyme Diagnostic Infectious Mono Test has a 99.2% agreement with the Quidel Concise® Plus™ Mono (476/480). There was no difference in performance between the university student health centers and the clinical laboratory.
Individuals with various levels of training tested a blind reproducibility panel using the Genzyme Diagnostics Contrast Mono Test. Panel samples in replicates of 5 were tested on three different days. The Contrast® Mono Test demonstrated reproducible results at three physician's office laboratories.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Agreement with predicate: 99.2% (476/480)
Contrast® Mono results versus Concise® Plus™ Mono:
Positive: 58 (Concise® Plus™ Mono Positive) vs 3 (Concise® Plus™ Mono Negative)
Negative: 1 (Concise® Plus™ Mono Positive) vs 418 (Concise® Plus™ Mono Negative)
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.
Quidel CONCISE® PLUS™ MONO
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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§ 866.5640 Infectious mononucleosis immunological test system.
(a)
Identification. An infectious mononucleosis immunological test system is a device that consists of the reagents used to measure by immunochemical techniques heterophile antibodies frequently associated with infectious mononucleosis in serum, plasma, and other body fluids. Measurements of these antibodies aid in the diagnosis of infectious mononucleosis.(b)
Classification. Class II (performance standards).
0
FEB 25 1997
510(k) Notification Genzyme Diagnostics Contrast® Mono August 30, 1996
510(k) Summary of Safety and Effectiveness Information Upon Which An Equivalence Determination Could Be Made
| Trade or Proprietary Name: | Contrast® Mono Test |
|---|---|
| Common or Usual Name: | Infectious Mononucleosis Test for Human IgM antibodies to Heterophile Antigen |
| Product Classification Number: | 21 CFR § 866.5640, Class II |
| Manufacturer: | Genzyme Diagnostics |
| 1531 Industrial Road | |
| San Carlos, CA 94070 | |
| Contact Person: | Delia R. Bethell, Ph.D. |
| Director of Research and Development | |
| Phone: (415) 594-0513 | |
| Fax: (415) 594-0571 | |
| Predicate Device: | Quidel CONCISE® PLUS™ MONO |
| Device Description: | Rapid membrane based immunoassay for the qualitative detection of human IgM antibodies to heterophile antigen using mouse monoclonal anti-IgM antibodies and heterophile antigen from bovine red blood cells. |
| Intended Use: | The qualitative detection of human IgM antibodies to heterophile antigen in serum, plasma or whole blood as an aid in the diagnosis of acute infectious mononucleosis for use in the physician's office laboratory and the clinical laboratory. |
A multicenter clinical study was performed in three physician's office laboratories, POL, (including two university student health clinical laboratory. The Genzyme Diagnostics Infectious Mono Test was provided to the sites. Each site also used the legally marketed Quidel Concise® Plus™ Mono Test. The Quidel test is marketed for laboratory and professional use.
The clinical laboratory performed the Genzyme and Quidel tests on serum and plasma specimens submitted for infectious mononucleosis. The university student health centers tested whole blood and plasma from students presenting with symptoms consistent with a diagnosis of infectious mononucleosis. A total of 480 serum, plasma and whole blood specimens were tested and compared with the reference method.
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510(k) Notification Genzyme Diagnostics Contrast® Mono August 30, 1996
The results demonstrate that the Genzyme Diagnostic Infectious Mono Test has a 99.2% agreement with the Quidel Concise® Plus™ Mono (476/480). There was no difference in performance between the university student health centers and the clinical laboratory.
| Contrast ® Mono | |||
|---|---|---|---|
| Positive | Negative | ||
| Positive | 58 | 3 | |
| Concise ® Plus™ Mono | |||
| Negative | 1 | 418 |
Individuals with various levels of training tested a blind reproducibility panel using the Genzyme Diagnostics Contrast Mono Test. Panel samples in replicates of 5 were tested on three different days. The Contrast® Mono Test demonstrated reproducible results at three physician's office laboratories.
These results establish that the Genzyme Diagnostic Contrast Mono Test is substantially equivalent to Quidel Concise® Plus Mono Test. The Contrast® Mono Test can detect human IgM antibodies to heterophile antigen in serum, plasma, and whole blood samples.
The intended use of the Genzyme Diagnostic Contrast Mono Test is for the detection of human IgM antibodies to heterophile antigen as an aid in the diagnosis of acute infectious mononucleosis. This product will be marketed for laboratory and professional use.