Cleared Traditional

K915325 - TSH CONTROL

K915325 is the FDA 510(k) clearance for TSH CONTROL by Polymedco, Inc.. It is a Class 1 Chemistry device (product code JJX) cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K915325 · Polymedco, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1992
Decision
101d
Days
Class 1
Risk

K915325 is an FDA 510(k) clearance for the TSH CONTROL. Classified as Single (specified) Analyte Controls (assayed And Unassayed) (product code JJX), Class I - General Controls.

Submitted by Polymedco, Inc. (Cortlandt Manor, US). The FDA issued a Cleared decision on March 2, 1992 after a review of 101 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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 Polymedco, Inc. devices

Submission Details

510(k) Number K915325 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 22, 1991
Decision Date March 02, 1992
Days to Decision 101 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
13d slower than avg
Panel avg: 88d · This submission: 101d
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 309
Devices cleared under the same product code (JJX) and FDA review panel - the closest regulatory comparables to K915325.
TANDEM-E HCG CALIBRATION VERIFICATION CONTROL SET
K920556 · Hybritech, Inc. · Jul 1992
TANDEM-E FERRITIN CALIBRATION VERIFICATION CONROL
K921252 · Hybritech, Inc. · Jul 1992
LYPHOCHEK(R) FRUCTOSAMINE CONTROL
K921089 · Bio-Rad · Apr 1992
MILENIA DATA REDUCTION
K915806 · Diagnostic Products Corp. · Jan 1992
TANDEM-E TSH CALIBRATION VERIFICATION CONTROL SET
K912439 · Hybritech, Inc. · Aug 1991
DIRECTIGEN 1-2-3 PREGNANCY CONTROLS
K911664 · Quidel Corp. · May 1991