Cleared Traditional

K860970 - PRECINORM IM AND PRECIPATH IM

K860970 is an FDA 510(k) clearance for PRECINORM IM AND PRECIPATH IM, 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 22-day FDA review.

K860970 · Boehringer Mannheim Corp. · Chemistry device
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Apr 1986
Decision
22d
Days
Class 1
Risk

K860970 is an FDA 510(k) clearance for the PRECINORM IM AND PRECIPATH IM. 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 April 3, 1986 after a review of 22 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 - K860970

510(k) Number K860970 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 1986
Decision Date April 03, 1986
Days to Decision 22 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
66d faster than avg
Panel avg: 88d · This submission: 22d
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 K860970.
CONTROL SERA LEVEL VALUES (MG/DL)
K861567 · E.I. Dupont DE Nemours & Co., Inc. · May 1986
IRON PROCEDURE
K861603 · Data Medical Associates, Inc. · May 1986
GILFORD UNIQUAL NORMAL CONTROL SERUM - ASSAYED
K861068 · Ciba Corning Diagnostics Corp. · Apr 1986
GILFORD UNIQUAL ABNORMAL CONTROL SERUM/UNASSAYED
K860998 · Ciba Corning Diagnostics Corp. · Apr 1986
GILFORD UNIQUAL NORMAL CONTROL SERUM/UNASSAYED
K861000 · Ciba Corning Diagnostics Corp. · Apr 1986
BOVINE CHEMISTRY CONTROL I.X AND II.X
K860355 · American Dade · Mar 1986