Myoglobin Assay for the Technicon Immuno 1 System

No FDA recalls found in the data synced 22 Oct 2026.

Full name

Myoglobin Assay for the Technicon Immuno 1 System (in-Vitro Diagnostic System)

510(k) Number

K962344 ↗

FDA Product Code

DDR

Device Class

Class II

Regulation

21 CFR Part 866.5680

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

• Estradiol Assay for the Technicon Immuno 1 System in-Vitro Diagnostic System

  Class I

  FDA 510(k) K951360 Active Cleared 2 May 1995

• Complexed Prostate Specific Antigen (Cpsa) Assay for the Bayer Advia Integrated Module System

  Class II

  FDA 510(k) K022288 Active Cleared 17 Dec 2002

• 8 Additional Assays for the Bayer Advia 1650 Chemistry System Open recall

  Class I

  FDA 510(k) K992662 Active Cleared 15 Feb 2000

• Clinitek Hcg Test Strips

  Class II

  FDA 510(k) K971209 Active Cleared 4 Apr 1997

• Bayer Diagnostics ACS:180 VB12, Bayer Diagnostics Advia Centaue VB12

  Class II

  FDA 510(k) K993571 Active Cleared 16 Dec 1999

• Glucometer Elite Xl Blood Glucose Meter

  Class II

  FDA 510(k) K990649 Active Cleared 9 Jul 1999

See all devices from Bayer Corp. →

• What is the Myoglobin Assay for the Technicon Immuno 1 System used for?

  This assay measures myoglobin levels in human serum or heparinized plasma. Myoglobin is a protein released during muscle injury, particularly in cardiac muscle, so elevated levels can indicate early signs of myocardial infarction (heart attack). It is designed to be used alongside clinical data, such as patient symptoms and electrocardiogram (EKG) results, to aid in diagnosis.

• How is the Myoglobin Assay supplied, and does it require sterilization?

  The Myoglobin Assay is supplied as a single-use diagnostic kit. It is packaged by the manufacturer in a way that ensures sterility, so no additional sterilization is required beyond opening the sealed packaging before use.

• Is the Myoglobin Assay compatible with MRI machines?

  No, the Myoglobin Assay is not MRI-compatible. This is an in-vitro diagnostic device intended for laboratory use on the Technicon Immuno 1 System, not for use in MRI environments.

• What storage instructions should be followed for the Myoglobin Assay?

  The Myoglobin Assay must be stored according to the manufacturer’s instructions to maintain its integrity. This typically includes keeping it in a cool, dry place, protected from direct light, and ensuring the packaging remains unopened until use.

• What regulatory pathway does the Myoglobin Assay follow?

  The Myoglobin Assay for the Technicon Immuno 1 System is regulated under the FDA 510(k) clearance pathway, with a clearance number of K962344. It is classified under product code DDR and falls under Class II with special controls, indicating it has been determined to be substantially equivalent to a legally marketed device.