Cleared Traditional

ELECSYS PRECICONTROL CARDIAC (K962575) - FDA 510(k) Clearance

Class I Chemistry device.

K962575 · 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

K962575 is an FDA 510(k) clearance for the ELECSYS PRECICONTROL CARDIAC. Classified as Multi-analyte Controls, All Kinds (assayed) (product code JJY), 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 K962575 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 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 K962575.
LIQUICHEK URIANLYSIS CONTROL (CAT. NO. 420,421,422,425,426)
K965171 · Bio-Rad · Jan 1997
N/T PROTEIN CONTROL SL
K964065 · Behring Diagnostics, Inc. · Nov 1996
LIQUICHEK IMMUNOASSAY PLUS CONTROL CATALOG NO. 360,361,362,363
K961941 · Bio-Rad · Sep 1996
N/T PROTEIN CONTROL SY/L, M AND H
K955858 · Behring Diagnostics, Inc. · Feb 1996
ROCHE CONTROL SERUM N
K954655 · Roche Diagnostic Systems, Inc. · Dec 1995
ROCHE CONTROL SERUM P
K954656 · Roche Diagnostic Systems, Inc. · Dec 1995