Cleared Traditional

K994439 - ACCESS CK-MB ON THE ACCESS IMMUNOASSAY ...

K994439 is the FDA 510(k) clearance for ACCESS CK-MB ON THE ACCESS IMMUNOASSAY ... by Beckman Coulter, Inc.. It is a Class 2 Chemistry device (product code JHX) cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K994439 · Beckman Coulter, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2000
Decision
22d
Days
Class 2
Risk

K994439 is an FDA 510(k) clearance for the ACCESS CK-MB ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33300, 33305, 33309, .... Classified as Fluorometric Method, Cpk Or Isoenzymes (product code JHX), Class II - Special Controls.

Submitted by Beckman Coulter, Inc. (Chaska, US). The FDA issued a Cleared decision on January 14, 2000 after a review of 22 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1215 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Beckman Coulter, Inc. devices

Submission Details

510(k) Number K994439 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 1999
Decision Date January 14, 2000
Days to Decision 22 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
66d faster than avg
Panel avg: 88d · This submission: 22d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JHX Fluorometric Method, Cpk Or Isoenzymes
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1215
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - JHX Fluorometric Method, Cpk Or Isoenzymes

All 29
Devices cleared under the same product code (JHX) and FDA review panel - the closest regulatory comparables to K994439.
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K022118 · Diagnostic Products Corp. · Jul 2002
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K004002 · Diagnostic Products Corp. · Feb 2001
ACCESS CK-MB ON THE ACCESS IMMUNOASSAY ANALYZER
K000716 · Beckman Coulter, Inc. · Mar 2000
VITROS IMMUNODIAGNOSTIC PRODUCTS CK-MB REAGENT PACK
K993068 · Ortho-Clinical Diagnostics · Oct 1999
IMMULITE TURBO CK-MB, MODELS LSKCP1, LSKCP5
K991797 · Diagnostic Products Corp. · Jun 1999
STRATUS (R) CS STAT FLUOROMETRIC ANALYZER, STRATUS (R) CS CKMB TEST PAK
K984067 · Dade Behring, Inc. · Jan 1999