Cleared Traditional

K781593 - RIA CONTROLS

K781593 is the FDA 510(k) clearance for RIA CONTROLS by Dade, Baxter Travenol Diagnostics, Inc.. It is a Class 1 Chemistry device (product code JJY) cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K781593 · Dade, Baxter Travenol Diagnostics, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1978
Decision
29d
Days
Class 1
Risk

K781593 is an FDA 510(k) clearance for the RIA CONTROLS. Classified as Multi-analyte Controls, All Kinds (assayed) (product code JJY), Class I - General Controls.

Submitted by Dade, Baxter Travenol Diagnostics, Inc. (Walker, US). The FDA issued a Cleared decision on October 17, 1978 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1660 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Dade, Baxter Travenol Diagnostics, Inc. devices

Submission Details

510(k) Number K781593 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 1978
Decision Date October 17, 1978
Days to Decision 29 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 88d · This submission: 29d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JJY Multi-analyte Controls, All Kinds (assayed)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1660
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - JJY Multi-analyte Controls, All Kinds (assayed)

All 463
Devices cleared under the same product code (JJY) and FDA review panel - the closest regulatory comparables to K781593.
DATA-TOPE TRI-RAC RADIOASSAY CONTROL
K790264 · Dade, Baxter Travenol Diagnostics, Inc. · Mar 1979
CALBIOCHEM-BEHRING LASER IMMUNOGLOBULIN
K790330 · Calbiochem-Behring Corp. · Mar 1979
CONTROL, PROTEIN ELECTROPHORESIS
K781893 · Sigma Chemical Co. · Dec 1978
COMP. CLIN. CHEM. CONTROL SERUM-DECISION
K780552 · Beckman Instruments, Inc. · May 1978
CHEMISTRY CONTROL-LOW & HIGH TQC TM
K770380 · Technicon Instruments Corp. · Apr 1977
TRIS BICARBONATE DILUENT
K760818 · Hyland Therapeutic Div., Travenol Laboratories · Nov 1976