Cleared Traditional

K962573 - ELECSYS PRECICONTROL TSH

K962573 is an FDA 510(k) clearance for ELECSYS PRECICONTROL TSH, manufactured by Boehringer Mannheim Corp.. The device is a Class 1 Chemistry device with product code JJX cleared through the Traditional 510(k) pathway after a 21-day FDA review.

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

FDA 510(k) Submission Details - K962573

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.

JJX Device Classification - Class 1, General Controls

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 381
Devices cleared under the same product code (JJX) and FDA review panel - the closest regulatory comparables to K962573.
ELECSYS CALCHECK TSH
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K963182 · Boehringer Mannheim Corp. · Aug 1996
OPUS MYOGLOBIN CONTROLS
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OPUS B12 CONTROLS
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ACS FRT4 IMMUNOASSAY
K961510 · Ciba Corning Diagnostics Corp. · Jun 1996
COMPLEMENT CONTROL
K960874 · Wako Chemicals USA, Inc. · Jun 1996