Cleared Traditional

ELECYS CALCHECK T 3 (K963167) - FDA 510(k) Clearance

Class I Chemistry device.

K963167 · Boehringer Mannheim Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1996
Decision
13d
Days
Class 1
Risk

K963167 is an FDA 510(k) clearance for the ELECYS CALCHECK T 3. Classified as Single (specified) Analyte Controls (assayed And Unassayed) (product code JJX), Class I - General Controls.

Submitted by Boehringer Mannheim Corp. (Indianapolis, US). The FDA issued a Cleared decision on August 27, 1996 after a review of 13 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 K963167 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 1996
Decision Date August 27, 1996
Days to Decision 13 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
75d faster than avg
Panel avg: 88d · This submission: 13d
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 K963167.
IMMULITE ACTH CONTROL MODULE (LACCM)
K963240 · Diagnostic Products Corp. · Aug 1996
ELECSYS CALCHECK FT3
K963163 · Boehringer Mannheim Corp. · Aug 1996
ELECSYS CALCHECK FT4
K963164 · Boehringer Mannheim Corp. · Aug 1996
ELECSYS CALCHECK T4
K963178 · Boehringer Mannheim Corp. · Aug 1996
ELECSYS CALCHECK TROPONIN T
K963143 · Boehringer Mannheim Corp. · Aug 1996
ELECSYS CALCHECK TSH
K963147 · Boehringer Mannheim Corp. · Aug 1996