Cleared Traditional

K012576 - CIC-C1Q EIA

K012576 is an FDA 510(k) clearance for CIC-C1Q EIA, manufactured by American Laboratory Products Co., Ltd.. The device is a Class 2 Immunology device with 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

FDA 510(k) Submission Details - K012576

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
68d slower than avg
Panel avg: 105d · This submission: 173d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DAK Device Classification - Class 2, Special Controls

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 16
Devices cleared under the same product code (DAK) and FDA review panel - the closest regulatory comparables to K012576.
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