Cleared Traditional

K012576 - CIC-C1Q EIA

K012576 is the FDA 510(k) clearance for CIC-C1Q EIA by American Laboratory Products Co., Ltd.. It is a Class 2 Immunology device (product code DAK) cleared through the Traditional 510(k) pathway after a 173-day FDA review.

K012576 · American Laboratory Products Co., Ltd. · Immunology device
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Jan 2002
Decision
173d
Days
Class 2
Risk

K012576 is an FDA 510(k) clearance for the CIC-C1Q EIA. Classified as Complement C1q, Antigen, Antiserum, Control (product code DAK), Class II - Special Controls.

Submitted by American Laboratory Products Co., Ltd. (Windham, US). The FDA issued a Cleared decision on January 29, 2002 after a review of 173 days - an extended review cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5240 - the FDA immunology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all American Laboratory Products Co., Ltd. devices

Submission Details

510(k) Number K012576 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 2001
Decision Date January 29, 2002
Days to Decision 173 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
69d slower than avg
Panel avg: 104d · This submission: 173d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DAK Complement C1q, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5240
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 Immunology devices follow this clearance model.

Regulatory Peers - DAK Complement C1q, Antigen, Antiserum, Control

All 14
Devices cleared under the same product code (DAK) and FDA review panel - the closest regulatory comparables to K012576.
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IC MICROASSAY
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