Cleared Traditional

K811832 - PRECINORM U & PRECIPATH U HUMAN SERUM

K811832 is an FDA 510(k) clearance for PRECINORM U & PRECIPATH U HUMAN SERUM, manufactured by Boehringer Mannheim Corp.. The device is a Class 1 Chemistry device with product code JJX cleared through the Traditional 510(k) pathway after a 16-day FDA review.

K811832 · Boehringer Mannheim Corp. · Chemistry device
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Jul 1981
Decision
16d
Days
Class 1
Risk

K811832 is an FDA 510(k) clearance for the PRECINORM U & PRECIPATH U HUMAN SERUM. Classified as Single (specified) Analyte Controls (assayed And Unassayed) (product code JJX), Class I - General Controls.

Submitted by Boehringer Mannheim Corp. (Mchenry, US). The FDA issued a Cleared decision on July 15, 1981 after a review of 16 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 - K811832

510(k) Number K811832 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 29, 1981
Decision Date July 15, 1981
Days to Decision 16 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
72d faster than avg
Panel avg: 88d · This submission: 16d
Pathway characteristics
Predicate-based equivalence.

JJX Device Classification - Class 1, General Controls

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 381
Devices cleared under the same product code (JJX) and FDA review panel - the closest regulatory comparables to K811832.
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URINE PREGNANCY TEST STANDARD/CONTR. PK
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HDL-CHOLESTEROL CONTROL SERUM
K802997 · Isolab, Inc. · Dec 1980
ULTIMATE DIRECT & TOTAL BILIRUBIN CONTRO
K802068 · Beckman Instruments, Inc. · Oct 1980