Cleared Traditional

K770011 - Q-PAK CHEMISTRY RADIORECEPTOR CONTROL B (FDA 510(k) Clearance)

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

K770011 · Hyland Therapeutic Div., Travenol Laboratories · Immunology device
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Apr 1977
Decision
105d
Days
Class 2
Risk

K770011 is an FDA 510(k) clearance for the Q-PAK CHEMISTRY RADIORECEPTOR CONTROL B. Classified as Calibrator, Multi-analyte Mixture (product code JIX), Class II - Special Controls.

Submitted by Hyland Therapeutic Div., Travenol Laboratories (Mchenry, US). The FDA issued a Cleared decision on April 18, 1977 after a review of 105 days - within the typical 510(k) review window.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 862.1150 - 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 Hyland Therapeutic Div., Travenol Laboratories devices

Submission Details

510(k) Number K770011 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 03, 1977
Decision Date April 18, 1977
Days to Decision 105 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
1d slower than avg
Panel avg: 104d · This submission: 105d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JIX Calibrator, Multi-analyte Mixture
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1150
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.