Cleared Traditional

HCG/TSH CONTROL- LEVEL 1/LEVEL 2/LEVEL 3 (K935599) - FDA 510(k) Clearance

Class I Chemistry device.

K935599 · Clinical Controls, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1994
Decision
346d
Days
Class 1
Risk

K935599 is an FDA 510(k) clearance for the HCG/TSH CONTROL- LEVEL 1/LEVEL 2/LEVEL 3. Classified as Multi-analyte Controls, All Kinds (assayed) (product code JJY), Class I - General Controls.

Submitted by Clinical Controls, Inc. (Grover Beach, US). The FDA issued a Cleared decision on October 31, 1994 after a review of 346 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Clinical Controls, Inc. devices

Submission Details

510(k) Number K935599 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 1993
Decision Date October 31, 1994
Days to Decision 346 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
258d slower than avg
Panel avg: 88d · This submission: 346d
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 672
Devices cleared under the same product code (JJY) and FDA review panel - the closest regulatory comparables to K935599.
V8 SP NORMAL CONTROL, ABNORMAL CONTROL
K131479 · Helena Laboratories · Oct 2013
DIMENSION VISTA PROTEIN 1 CALIBRATOR, PROTEIN1 CONTROL L,M,H
K071980 · Dade Behring, Inc. · Sep 2007
TDM CONTROL SET, MODEL CAT# 04521536
K070200 · Roche Diagnostics Corp. · Mar 2007
COBAS INTEGRA CERULOPLASMIN
K062379 · Roche Diagnostics Corp. · Jan 2007
TDM CONTROL SET
K060429 · Roche Diagnostics Corp. · Mar 2006
ELECSYS PRECICONTROL BONE
K051543 · Roche Diagnostics Corp. · Oct 2005