Cleared Traditional

K770012 - Q-PAK CHEMISTRY RADIORECEPTOR CONTROL C

K770012 is an FDA 510(k) clearance for Q-PAK CHEMISTRY RADIORECEPTOR CONTROL C, manufactured by Hyland Therapeutic Div., Travenol Laboratories. The device is a Class 2 Immunology device with product code JIX cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K770012 · Hyland Therapeutic Div., Travenol Laboratories · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1977
Decision
105d
Days
Class 2
Risk

K770012 is an FDA 510(k) clearance for the Q-PAK CHEMISTRY RADIORECEPTOR CONTROL C. 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

FDA 510(k) Submission Details - K770012

510(k) Number K770012 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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
At panel average
Panel avg: 105d · This submission: 105d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JIX Device Classification - Class 2, Special Controls

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.

Regulatory Peers - JIX Calibrator, Multi-analyte Mixture

All 272
Devices cleared under the same product code (JIX) and FDA review panel - the closest regulatory comparables to K770012.
COMP. CLIN. CHEM. REF. SERUM-BENCHMARK
K780553 · Beckman Instruments, Inc. · May 1978
Q-PAK CHEMISTRY RADIORECEPTOR CONTROL A
K770010 · Hyland Therapeutic Div., Travenol Laboratories · Apr 1977
Q-PAK CHEMISTRY RADIORECEPTOR CONTROL B
K770011 · Hyland Therapeutic Div., Travenol Laboratories · Apr 1977
SMA REFERENCE SERUM 3
K770142 · Technicon Instruments Corp. · Feb 1977
OB-GYN CONTROL SERA (CODE 196300)
K761309 · Amersham Corp. · Dec 1976