Cleared Traditional

K772017 - IN VITRO THEOPHYLLINE RIA TEST

K772017 is an FDA 510(k) clearance for IN VITRO THEOPHYLLINE RIA TEST, manufactured by Clinical Assays, Inc.. The device is a Class 2 Immunology device with product code KLS cleared through the Traditional 510(k) pathway after a 152-day FDA review.

K772017 · Clinical Assays, Inc. · Immunology device
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Mar 1978
Decision
152d
Days
Class 2
Risk

K772017 is an FDA 510(k) clearance for the IN VITRO THEOPHYLLINE RIA TEST. Classified as Enzyme Immunoassay, Theophylline (product code KLS), Class II - Special Controls.

Submitted by Clinical Assays, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 27, 1978 after a review of 152 days - an extended review cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 862.3880 - 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 Clinical Assays, Inc. devices

FDA 510(k) Submission Details - K772017

510(k) Number K772017 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 26, 1977
Decision Date March 27, 1978
Days to Decision 152 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
47d slower than avg
Panel avg: 105d · This submission: 152d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KLS Device Classification - Class 2, Special Controls

Product Code KLS Enzyme Immunoassay, Theophylline
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3880
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.