Cleared Traditional

K974111 - QUIDEL CH50 EQ EIA

K974111 is an FDA 510(k) clearance for QUIDEL CH50 EQ EIA, manufactured by Quidel Corp.. The device is a Class 2 Immunology device with product code DAE cleared through the Traditional 510(k) pathway after a 271-day FDA review.

K974111 · Quidel Corp. · Immunology device
Download Printable Device Report (PDF)
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Jul 1998
Decision
271d
Days
Class 2
Risk

K974111 is an FDA 510(k) clearance for the QUIDEL CH50 EQ EIA. Classified as Complement C9, Antigen, Antiserum, Control (product code DAE), Class II - Special Controls.

Submitted by Quidel Corp. (San Diego, US). The FDA issued a Cleared decision on July 29, 1998 after a review of 271 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 Quidel Corp. devices

FDA 510(k) Submission Details - K974111

510(k) Number K974111 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 31, 1997
Decision Date July 29, 1998
Days to Decision 271 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
166d slower than avg
Panel avg: 105d · This submission: 271d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DAE Device Classification - Class 2, Special Controls

Product Code DAE Complement C9, 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 - DAE Complement C9, Antigen, Antiserum, Control

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