Cleared Traditional

DCL MICROALBUMIN ASSAY, MODEL 252-20 (K051191) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K051191 · Diagnostic Chemicals , Ltd. · Chemistry device
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Jul 2005
Decision
56d
Days
Class 2
Risk

K051191 is an FDA 510(k) clearance for the DCL MICROALBUMIN ASSAY, MODEL 252-20. Classified as Albumin, Antigen, Antiserum, Control (product code DCF), Class II - Special Controls.

Submitted by Diagnostic Chemicals , Ltd. (Charlottetown, P.E., CA). The FDA issued a Cleared decision on July 5, 2005 after a review of 56 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 866.5040 - 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 Diagnostic Chemicals , Ltd. devices

Submission Details

510(k) Number K051191 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 10, 2005
Decision Date July 05, 2005
Days to Decision 56 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 88d · This submission: 56d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DCF Albumin, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5040
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 - DCF Albumin, Antigen, Antiserum, Control

All 36
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