Cleared Traditional

K000196 - ACCESS MYOGLOBIN ON THE ACCESS IMMUNOAS...

K000196 is the FDA 510(k) clearance for ACCESS MYOGLOBIN ON THE ACCESS IMMUNOAS... by Beckman Coulter, Inc.. It is a Class 2 Chemistry device (product code DDR) cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K000196 · Beckman Coulter, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2000
Decision
28d
Days
Class 2
Risk

K000196 is an FDA 510(k) clearance for the ACCESS MYOGLOBIN ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33310, 33315, 333.... Classified as Myoglobin, Antigen, Antiserum, Control (product code DDR), Class II - Special Controls.

Submitted by Beckman Coulter, Inc. (Chaska, US). The FDA issued a Cleared decision on February 18, 2000 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 866.5680 - 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 K000196 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 2000
Decision Date February 18, 2000
Days to Decision 28 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
60d faster than avg
Panel avg: 88d · This submission: 28d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DDR Myoglobin, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5680
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 - DDR Myoglobin, Antigen, Antiserum, Control

All 32
Devices cleared under the same product code (DDR) and FDA review panel - the closest regulatory comparables to K000196.
VITROS IMMUNODIAGNOSTIC PRODUCTS MYOGLOBIN REAGENT PACK
K033300 · Ortho-Clinical Diagnostics, Inc. · Nov 2003
MYOGLOBIN AND MYOGLOBIN CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 973243, 973244
K021229 · Beckman Coulter, Inc. · Jun 2002
RANDOX MYOGLOBIN
K010700 · Randox Laboratories, Ltd. · May 2001
K-ASSAY MYOGLOBIN ASSAY, K-ASSAY MYOGLOBIN CALIBRATOR
K992976 · Kamiya Biomedical Co. · Nov 1999
IMMULITE TURBO MYOGLOBIN, MODELS LSKMY1, LSKMY5
K991796 · Diagnostic Products Corp. · Jun 1999
MODIFICATION TO IMMULITE MYOGLOBIN, MODEL LKMY1, LKMY5
K991277 · Diagnostic Products Corp. · Apr 1999