(42 days)
K922125/A
K922125/A
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on a standard immunoassay technology with a modification for sample type.
No.
The device is described as a "Fluorometric Enzyme Immunoassay," which is a diagnostic test used to measure a substance (myoglobin) in patient samples, not to treat a disease.
Yes
Explanation: The device is an "Enzyme Immunoassay" used for analyzing patient samples (serum and heparinized plasma) to measure Myoglobin, which is a common diagnostic test.
No
The device is described as a "Fluorometric Enzyme Immunoassay," which is a laboratory test method involving chemical reactions and fluorescence measurement, indicating it is a physical assay kit or system, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's a "Fluorometric Enzyme Immunoassay." Immunoassays are laboratory tests performed on biological samples (like serum and plasma in this case) to detect and measure specific substances. This is a core characteristic of IVDs.
- Sample Type: The device analyzes "serum and heparinized plasma samples." These are biological specimens taken from a patient, which is typical for IVD testing.
- Device Description: The device is described as a "Stratus® Myoglobin Fluorometric Enzyme Immunoassay." The term "immunoassay" again points to a laboratory test performed on biological samples.
- Performance Study: The performance study involves analyzing "patient samples" to assess the device's performance. This is a standard practice for evaluating IVDs.
- Predicate Device: The predicate device is also described as a "Stratus® Myoglobin Fluorometric Enzyme Immunoassay," indicating that the original device was also an IVD.
Based on these points, the device clearly fits the definition of an In Vitro Diagnostic device, which is used to examine specimens from the human body to provide information for diagnosis, treatment, or prevention of disease.
N/A
Intended Use / Indications for Use
The proposed Stratus® Myoglobin Fluorometric Enzyme Immunoassay is substantially equivalent in intended use and technological characteristics to the current Stratus® Myoglobin Fluorometric Enzyme Immunoassay, manufactured by Dade International Inc., Miami, FL, previously cleared under Document Control No., K922125/A. The proposed device is being modified to include heparinized plasma as a sample type.
Product codes
Not Found
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
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
During an in-house comparative performance study, 101 patient samples were analyzed in duplicate for both serum and heparinized plasma samples using the Stratus® Myoglobin Assay procedure.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
During an in-house comparative performance study, 101 patient samples were analyzed in duplicate for both serum and heparinized plasma samples using the Stratus® Myoglobin Assay procedure. The correlation coefficient was calculated at 0.98 and the regression equation was y = 0.94x + 7.09, where y = plasma samples. The correlation coefficient and the regression equation were found to be acceptable.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
The correlation coefficient was calculated at 0.98
Predicate Device(s)
K922125/A
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 866.5680 Myoglobin immunological test system.
(a)
Identification. A myoglobin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the myoglobin (an oxygen storage protein found in muscle) in serum and other body fluids. Measurement of myoglobin aids in the rapid diagnosis of heart or renal disease.(b)
Classification. Class II (performance standards).
0
K965213 FEB 10 1997
510(k) Summary of Safety and Effectiveness Information Stratus® Myoglobin Fluorometric Enzyme Immunoassay December 27, 1996
Dade International Inc. 2173 N.W. 99th Avenue Miami, FL 33172 Contact Person: Radha Goolabsingh at 305-392-5621 or Radames Riesgo at 305-5615, or by facsimile at 305-392-5622.
Trade or Proprietary Name: Stratus® Myoglobin Fluorometric Enzyme Immunoassay
| Common or Usual Name: | Myoglobin immunological test system |
|---|---|
| Classification Name: | None |
| Registration Number: | Manufacturer |
| Dade International Inc. | |
|---|---|
| 2173 N.W. 99th Avenue | |
| Miami, FL 33172 | 1025506 |
| (formerly at 9750 N.W. 25 Street, Miami, FL 33172) | |
| Dade International Inc. | |
| 1851 Delaware Parkway | |
| Miami, Florida 33125 | 1017272 |
The proposed Stratus® Myoglobin Fluorometric Enzyme Immunoassay is substantially equivalent in intended use and technological characteristics to the current Stratus® Myoglobin Fluorometric Enzyme Immunoassay, manufactured by Dade International Inc., Miami, FL, previously cleared under Document Control No., K922125/A. The proposed device is being modified to include heparinized plasma as a sample type.
During an in-house comparative performance study, 101 patient samples were analyzed in duplicate for both serum and heparinized plasma samples using the Stratus® Myoglobin Assay procedure. The correlation coefficient was calculated at 0.98 and the regression equation was y = 0.94x + 7.09, where y = plasma samples. The correlation coefficient and the regression equation were found to be acceptable.