ACCESS CK-MB ON THE ACCESS IMMUNOASSAY ANALYZER - 33309
510(k) K994439
Active
Valid until
Not listed
FDA recalls
None foundTrust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK994439 | Date14 Jan 2000 | StatusActive |
| European Union | CE/IVDR EUDAMED | Number— | Date— | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- 510(k) Number
- FDA Product Code
- JHX
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.1215
- Advisory Committee
- Clinical Chemistry
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 20 Sep 2026
The Access CK-MB on the Access Immunoassay Analyzer is a fluorometric immunoassay device designed for the quantitative measurement of creatine kinase-MB isoenzyme (CK-MB) in serum or plasma. CK-MB is a cardiac biomarker used to detect myocardial infarction and assess cardiac injury, distinguishing it from other creatine kinase isoforms. This device employs a fluorometric detection method to provide accurate and sensitive results for clinical chemistry applications.
The device is intended for use in clinical laboratories and operates on the Access Immunoassay Analyzer platforms (Models 33300, 33305, 33309, 33306). It is supplied as a reagent kit, including calibrators, quality controls, wash buffer, and substrate, requiring no additional sterilization as it is non-sterile and intended for single-use per assay. The device is classified under product code JHX as a Class II medical device under the FDA’s Special Controls and has received FDA 510(k) clearance and IVDR authorization. Storage conditions and shelf life are specified in the accompanying documentation.
Other devices from Beckman Coulter, Inc.
Questions
AI-generated answers, 20 Sep 2026
What clinical purpose does the Access CK-MB assay serve on the Access Immunoassay Analyzer, and how does it differ from other creatine kinase tests?
The Access CK-MB assay quantifies the creatine kinase-MB isoenzyme (CK-MB) in serum or plasma to detect myocardial infarction and assess cardiac injury. Unlike other creatine kinase tests, CK-MB specifically distinguishes cardiac damage from skeletal muscle or brain injury, as it is uniquely elevated in myocardial tissue. This fluorometric immunoassay provides sensitive and accurate results for clinical chemistry applications, helping clinicians differentiate cardiac events from non-cardiac conditions.
Is the Access CK-MB reagent kit sterile, and how should it be handled for single-use assays?
The Access CK-MB reagent kit is not sterile and is explicitly designed for single-use per assay. Since it includes calibrators, quality controls, wash buffer, and substrate, no additional sterilization is required. Each component is intended for one-time use in the Access Immunoassay Analyzer (Models 33300, 33305, 33309, 33306) to ensure accurate and contamination-free results.
What models of the Access Immunoassay Analyzer are compatible with the Access CK-MB assay, and how is the reagent kit supplied?
The Access CK-MB assay is compatible with four models of the Access Immunoassay Analyzer: 33300, 33305, 33309, and 33306. The reagent kit is supplied as a complete system, including calibrators, quality controls, wash buffer, and substrate—all pre-packaged for immediate use in the specified analyzer platforms. No additional components are required beyond what is provided in the kit.
What regulatory pathways has the Access CK-MB assay undergone, and how is it classified under FDA and IVDR frameworks?
The Access CK-MB assay has received FDA 510(k) clearance under product code JHX, classified as a Class II medical device with Special Controls for fluorometric immunoassays. It is also authorized under the In Vitro Diagnostic Regulation (IVDR). The device was determined Substantially Equivalent (SESE) to a predicate through a traditional 510(k) review, ensuring compliance with both U.S. and EU regulatory standards for clinical chemistry applications.