Cleared Traditional

K771657 - EMIT THYROXINE CONTROL

K771657 is the FDA 510(k) clearance for EMIT THYROXINE CONTROL by Syva Co.. It is a Class 1 Chemistry device (product code JJX) cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K771657 · Syva Co. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1977
Decision
45d
Days
Class 1
Risk

K771657 is an FDA 510(k) clearance for the EMIT THYROXINE CONTROL. Classified as Single (specified) Analyte Controls (assayed And Unassayed) (product code JJX), Class I - General Controls.

Submitted by Syva Co. (Mchenry, US). The FDA issued a Cleared decision on October 13, 1977 after a review of 45 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 Syva Co. devices

Submission Details

510(k) Number K771657 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 29, 1977
Decision Date October 13, 1977
Days to Decision 45 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
43d faster than avg
Panel avg: 88d · This submission: 45d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JJX Single (specified) Analyte Controls (assayed And Unassayed)
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 - JJX Single (specified) Analyte Controls (assayed And Unassayed)

All 370
Devices cleared under the same product code (JJX) and FDA review panel - the closest regulatory comparables to K771657.
SERUM PAK, HCG CONTROL
K790129 · Mallinckrodt Critical Care · Mar 1979
ACA LIPASE VERIFIERS
K772285 · E.I. Dupont DE Nemours & Co., Inc. · Jan 1978
ACA BILIRUBIN CALIBRATOR
K771798 · E.I. Dupont DE Nemours & Co., Inc. · Oct 1977
KETOTROL-E
K760885 · Sigma Chemical Co. · Nov 1976
LIPID CONTROL
K760449 · Sigma Chemical Co. · Oct 1976