(59 days)
Syva EMIT® Vancomycin Assay
Not Found
No
The summary describes a quantitative immunoassay for measuring vancomycin levels and does not mention any AI or ML components.
No.
The device measures a substance to aid in diagnosis and treatment, but it does not directly administer therapy or provide a therapeutic effect itself.
Yes
The "Intended Use / Indications for Use" section explicitly states that "Measurements of vancomycin are used in the diagnosis and treatment of vancomycin overdose and in monitoring levels of vancomycin..."
No
The device is described as an "in vitro method" using a specific assay on a "Technicon Immuno-J system," which are hardware components used for laboratory testing. The performance studies also refer to comparing performance with a "similar device (Syva EMIT Vancomycin Assay)," further indicating a hardware-based system.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that it is an "in vitro method" and is used to measure a substance (vancomycin) in human serum or plasma. This is a key characteristic of an IVD.
- Sample Type: It analyzes human biological samples (serum or plasma).
- Purpose: The measurements are used in the "diagnosis and treatment of vancomycin overdose and in monitoring levels of vancomycin to ensure appropriate therapy." This directly relates to medical diagnosis and treatment decisions, which is the purpose of IVDs.
The information provided clearly aligns with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
This in vitro method is intended to quantitatively measure vancomysia, an antibiotic, in human serum or plasma (heparin) using Syva EMIT® Vancomycio Assay on a Technicon Immuno-J system. Messurements of vancomycin are used in the diagnosis and treatment of vancomycin overdose and in monitoring levels of vancomycin to easure appropriate therapy.
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
Not Found
Summary of Performance Studies
Listed below is a comparison of the performance between the Immuno 1 Vancomycin method and a similar device that was granted clearance of substantial equivalence (Syva EMIT Vancomycin Assay, Bebring Diagnotics Inc.). The information used in the Summary of Safety and Effectiveness was extracted from the Immuno 1 Vancomvan method sheet and the Syva EMIT Vancomycin Assay Insert Sheet.
Key Metrics
Minimum Detectable Conc.: 0.2 µg/mL
Precision (Between-Run): 8.5 µg/mL 5.3%; 39.5 µg/mL 6.6%; 50.6 µg/mL 5.3%
Correlation: y = 1.032 x - 0.006 where y = Immuno 1 Vancomycin method, x = Syva EMIT® Vancomycin Assay*, n = 53, r = 0.981, Syx = 1.779 µg/mL
Predicate Device(s)
Syva EMIT® Vancomycin Assay, Bebring Diagnotics Inc.
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.3950 Vancomycin test system.
(a)
Identification. A vancomycin test system is a device intended to measure vancomycin, an antibiotic drug, in serum. Measurements obtained by this device are used in the diagnosis and treatment of vancomycin overdose and in monitoring the level of vancomycin to ensure appropriate therapy.(b)
Classification. Class II.
0
P.2/2
JAN 1 3 1997
SUMMARY OF SAFETY AND EFFECTIVENESS
Vancomycin Method for Bayer Technicon Immuno 1° System
Listed below is a comparison of the performance between the Immuno 1 Vancomycin method and a similar device that was granted clearance of substantial equivalence (Syva EMIT Vancomycin Assay, Bebring Diagnotics Inc.). The information used in the Summary of Safety and Effectiveness was extracted from the Immuno 1 Vancomvan method sheet and the Syva EMIT Vancomycin Assay Insert Sheet,
INTENDED USED
This in vitro method is intended to quantitatively measure vancomysia, an antibiotic, in human serum or plasma (heparin) using Syva EMIT® Vancomycio Assay on a Technicon Immuno-J system. Messurements of vancomycin are used in the diagnosis and treatment of vancomycin overdose and in monitoring levels of vancomycin to easure appropriate therapy.
| METHOD | Immuno 1 Vancomycin | Syva EMIT® Vancomycin
(predicate Device) |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------|
| Part No. | Reagents T01-3705-01
Calibrators T03-3714-01 | Reagents 6W419UL
Calibrators 6W519UL |
| Minimum Detectable Conc. | 0.2 µg/mL | Not Listed |
| Precision (Between-Run) | 8.5 µg/mL 5.3%
39.5 µg/mL 6.6%
50.6 µg/mL 5.3% | 7.2 µg/mL 10.3%
38.7 µg/mL 5.6%
39.5 µg/mL 6.2% |
| Correlation | y = 1.032 x - 0.006
where
y = Immuno 1 Vancomycin method
x = Syva EMIT® Vancomycin Assay*
n = 53
r = 0.981
Syx = 1.779 µg/mL | |
This assay was performed on Technicon RA-1000" Instrument using parameters and protocol specified in Behring Application Sheet.
Gabriel J. Muraca, Jr. Manager Regulatory Affairs Bayer Corporation 511 Benedict Avenue Tarrytown, New York 10591-5097 Date