Cleared Traditional

BOEHRINGER MANNHEIM ELECSYS PRESICONTROL CARDIAC (K983492) - FDA 510(k) Clearance

Class I Chemistry device.

K983492 · Boehringer Mannheim Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1998
Decision
4d
Days
Class 1
Risk

K983492 is an FDA 510(k) clearance for the BOEHRINGER MANNHEIM ELECSYS PRESICONTROL CARDIAC. Classified as Multi-analyte Controls, All Kinds (assayed) (product code JJY), Class I - General Controls.

Submitted by Boehringer Mannheim Corp. (Indianapolis, US). The FDA issued a Cleared decision on October 9, 1998 after a review of 4 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 K983492 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 05, 1998
Decision Date October 09, 1998
Days to Decision 4 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
84d faster than avg
Panel avg: 88d · This submission: 4d
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 183
Devices cleared under the same product code (JJY) and FDA review panel - the closest regulatory comparables to K983492.
LIQUICHEK SERUM VOLATILES CONTROL, MODELS 383 AND 384
K984225 · Bio-Rad · Dec 1998
ELECSYS CALCHECK TROPONIN T
K984372 · Boehringer Mannheim Corp. · Dec 1998
ARCHITECT TOTAL T4 MASTERCHECK, LIST NO. 6C49-05
K984074 · Bio-Rad · Nov 1998
ELECSYS CALCHECK MYOGLOBIN
K983166 · Boehringer Mannheim Corp. · Sep 1998
TUMOR MARKER CONTROL
K982473 · Diagnostic Products Corp. · Aug 1998
IMMULITE PSA CONTROL MODULE, MODEL LPSCM
K982637 · Diagnostic Products Corp. · Aug 1998