(179 days)
Not Found
No
The device description details a standard immunoturbidimetric assay with results determined by interpolation from a calibration curve, which does not involve AI/ML. The summary explicitly states "Mentions AI, DNN, or ML: Not Found".
No
This device is for in vitro diagnostic use, intended to measure myoglobin levels as an aid in diagnosis, not for treating a condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "used as an aid in the diagnosis of acute myocardial infarction" and is "For in vitro diagnostic use only."
No
The device description clearly states it is a latex enhanced immunoturbidimetric assay, which is a chemical reaction-based method requiring physical reagents and a spectrophotometer for measurement. This is not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
The intended use statement explicitly states: "For in vitro diagnostic use only." This is a clear indicator that the device is intended to be used outside of the body to examine specimens for diagnostic purposes.
Furthermore, the description of the device and its intended use aligns with the definition of an IVD: it is a test system used to measure a substance (myoglobin) in human samples (serum and plasma) to aid in the diagnosis of a medical condition (acute myocardial infarction). The calibrators and controls are also described as being for in vitro diagnostic use, which is typical for IVD test systems.
N/A
Intended Use / Indications for Use
The Diazyme Myoglobin Assay is for the quantitative determination of myoglobin in human serum and plasma. Measurement of myoglobin is used as an aid in the diagnosis of acute myocardial infarction. For in vitro diagnostic use only.
The Diazyme Myoglobin Calibrator Set is intended for use in the calibration of the Diazyme Myoglobin Assay. For in vitro diagnostic use only.
The Diazyme Myoglobin Control Set is intended for use as quality controls for the Diazyme Myoglobin Assay. For in vitro diagnostic use only.
Product codes
DDR, JIT, JJX
Device Description
The Diazyme Myoglobin Assay is based on a latex enhanced immunoturbidimetric assay. When an antigen-antibody reaction occurs between myoglobin in a sample and anti-myoglobin antibodies which have been sensitized to latex particles, agglutination occurs. This agglutination is detected as an absorbance change (570 nm), with the magnitude of the change being proportional to the quantity of myoglobin in the sample. The actual concentration is then determined by the interpolation from a calibration curve prepared from calibrators of known concentration. The device consists of Reagent 1 (100 mM Tris buffer solution with 0.09% sodium azide), Reagent 2 (Suspension of latex particles (
§ 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
.
510(k) Summary
JUN 0 7 2013
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
| Submitter's name: | Diazyme Laboratories |
|---|---|
| Submitter's address: | 12889 Gregg Court |
| Poway, CA 92064 | |
| USA | |
| Name of Contact Person: | Dr. Abhijit Datta |
| Diazyme Laboratories | |
| 12889 Gregg Court | |
| Poway, CA 92064 | |
| Phone: 858-455-4762 | |
| Fax: 858-455-3701 | |
| Date the Summary was Prepared: | June 4, 2013 |
| Name of the Device | Diazyme Myoglobin Assay |
| Diazyme Myoglobin Calibrator Set | |
| Diazyme Myoglobin Control Set | |
| Trade Name: | Diazyme Myoglobin Assay |
| Diazyme Myoglobin Calibrator Set | |
| Diazyme Myoglobin Control Set | |
| Common/Usual Name | Diazyme Myoglobin Assay |
| Device Classification Name | Myoglobin Test System |
| Product code: | DDR (Myoglobin, Antigen, Antiserum, Control) |
| JIT - Calibrator, Secondary | |
| JJX - Single (specified) Analyte Controls | |
| (Assayed and Unassayed) | |
| Panel: | Immunology (82) |
| Submission Type | 510k |
| Regulation Number | 21CFR 866.5680 |
| Device Class | Class II |
1
Predicate Device:
Roche Tina-Quant Myoglobin Gen. 2 Test System and C.f.a.s. (Calibrators for automated systems) Myoglobin (K061683) Myoglobin Control Set (K973358)
Manufacturing Address
Diazyme Laboratories 12889 Gregg Court Poway, CA 92064 USA
Establishment Registration 2032900
DESCRIPTION OF THE DEVICE
Clinical Significance
Myoglobin is a ~17kDa oxygen-binding protein whose concentration is elevated in response to a muscle injury. Characterized by x-ray crystallography in the 1950s, myoglobin has developed into an important marker for the diagnosis of a recent cardiac event. After a cardiac event or muscle injury occurs, its concentration rises and can be detected in vitro approximately 2 hours after the onset of symptoms and its measurement aids in the diagnosis of ST segment elevated myocardial infarction, which can ultimately lead to cardiac arrest. High concentrations of myoglobin also indicate extensive muscle damage (rhabodmyolysis) and can cause renal failure as high levels of the marker are toxic to the kidneys. The rapid increase in the concentration of myoglobin after muscular trauma makes it an important diagnostic indicator of cardiac stress and muscle damage, and provides early detection of necrosis in cardiac and skeletal muscle.
Assay Principle
The Diazyme Myoglobin Assay is based on a latex enhanced immunoturbidimetric assay. When an antigen-antibody reaction occurs between myoglobin in a sample and anti-myoglobin antibodies which have been sensitized to latex particles, agglutination occurs. This agglutination is detected as an absorbance change (570 nm), with the magnitude of the change being proportional to the quantity of myoglobin in the sample. The actual concentration is then determined by the interpolation from a calibration curve prepared from calibrators of known concentration.
Indications for Use:
The Diazyme Myoglobin Assay is for the quantitative determination of myoglobin in human serum and plasma. Measurement of myoglobin is used as an aid in the diagnosis of acute myocardial infarction. For in vitro diagnostic use only.
The Diazyme Myoglobin Calibrator Set is intended for use in the calibration of the Diazyme Myoglobin Assay. For in vitro diagnostic use only.
The Diazyme Myoglobin Control Set is intended for use as quality controls for the Diazyme Myoglobin Assay. For in vitro diagnostic use only.
2
| Table 1 Summarv of Assay Kit Components | ||||
|---|---|---|---|---|
| -- | -- | -- | -- | ----------------------------------------- |
| Roche Tina-Quant Myoglobin Gen. 2,
C.f.a.s. Myoglobin (K061683), and
| Myoglobin Control Set (K973358) | Diazyme Myoglobin Assay |
|---|---|
| Reagent 1 | |
| buffer solution, ready to use | Reagent 1 |
| 100 mM Tris buffer solution with 0.09% sodium | |
| azide, ready to use. | |
| Reagent 2 | |
| Suspension of anti-human myoglobin | |
| coated latex particles, ready to use | Reagent 2 |
| Suspension of latex particles ( |