Cleared Traditional

K874230 - PRECINORM L

K874230 is an FDA 510(k) clearance for PRECINORM L, manufactured by Boehringer Mannheim Corp.. The device is a Class 1 Chemistry device with product code JJY cleared through the Traditional 510(k) pathway after a 39-day FDA review.

K874230 · Boehringer Mannheim Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1987
Decision
39d
Days
Class 1
Risk

K874230 is an FDA 510(k) clearance for the PRECINORM L. 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 November 23, 1987 after a review of 39 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 - K874230

510(k) Number K874230 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 1987
Decision Date November 23, 1987
Days to Decision 39 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
49d faster than avg
Panel avg: 88d · This submission: 39d
Pathway characteristics
Predicate-based equivalence.

JJY Device Classification - Class 1, General Controls

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 487
Devices cleared under the same product code (JJY) and FDA review panel - the closest regulatory comparables to K874230.
REFERENCE HIGH LEVEL ASSAYED CHEM. CONTROL SERUM
K874809 · Biotrol, USA, Inc. · Jan 1988
DC-TROL LEVEL 1 OR 2
K874772 · Diagnostic Chemicals, Ltd. (Usa) · Jan 1988
REFERENCE ASSAYED CHEMISTRY CONTROL SERUM
K874810 · Biotrol, USA, Inc. · Jan 1988
BIOTROL-33 PLUS PATHOLOGIQUE ASSAYED CHEM. CONTROL
K872777 · Biotrol, USA, Inc. · Aug 1987
BIOTROL-33 PLUS ASSAYED CHEMISTRY CONTROL SERUM
K872785 · Biotrol, USA, Inc. · Aug 1987
DADE MONI-TROL CHEMISTRY CONTROL/CALIBRATOR
K871977 · American Dade · Jul 1987