Cleared Traditional

ELECSYS PRECICONTROL TSH (K962573) - FDA 510(k) Clearance

Class I Chemistry device.

K962573 · Boehringer Mannheim Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1996
Decision
21d
Days
Class 1
Risk

K962573 is an FDA 510(k) clearance for the ELECSYS PRECICONTROL TSH. Classified as Single (specified) Analyte Controls (assayed And Unassayed) (product code JJX), Class I - General Controls.

Submitted by Boehringer Mannheim Corp. (Concord, US). The FDA issued a Cleared decision on July 22, 1996 after a review of 21 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 Boehringer Mannheim Corp. devices

Submission Details

510(k) Number K962573 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 1996
Decision Date July 22, 1996
Days to Decision 21 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
67d faster than avg
Panel avg: 88d · This submission: 21d
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 194
Devices cleared under the same product code (JJX) and FDA review panel - the closest regulatory comparables to K962573.
ELECSYS CALCHECK TSH
K963147 · Boehringer Mannheim Corp. · Aug 1996
ELECSYS CALCHECK CK-MB
K963182 · Boehringer Mannheim Corp. · Aug 1996
OPUS MYOGLOBIN CONTROLS
K962841 · Behring Diagnostics, Inc. · Aug 1996
OPUS B12 CONTROLS
K962694 · Behring Diagnostics, Inc. · Jul 1996
OPUS T3 CONTROLS
K961206 · Behring Diagnostics, Inc. · Apr 1996
PSA CONTROLS
K960154 · Diagnostic Products Corp. · Mar 1996