Cleared Traditional

80 MG/DL GLUCOSE CONTROL (K844581) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K844581 · Boehringer Mannheim Corp. · Chemistry device
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Dec 1984
Decision
19d
Days
Class 2
Risk

K844581 is an FDA 510(k) clearance for the 80 MG/DL GLUCOSE CONTROL. Classified as Calibrator, Primary (product code JIS), Class II - Special Controls.

Submitted by Boehringer Mannheim Corp. (Indianapolis, US). The FDA issued a Cleared decision on December 12, 1984 after a review of 19 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1150 - 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 K844581 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 23, 1984
Decision Date December 12, 1984
Days to Decision 19 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
69d faster than avg
Panel avg: 88d · This submission: 19d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JIS Calibrator, Primary
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1150
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - JIS Calibrator, Primary

All 49
Devices cleared under the same product code (JIS) and FDA review panel - the closest regulatory comparables to K844581.
EMDS THEOPHYLLINE CALIBRATORS ITEM NO. 67---/93
K862453 · Em Diagnostic Systems, Inc. · Aug 1986
EMDS(TM) ELEVATED BILIRUBIN CALIBRATOR # 67627/95
K862704 · Em Diagnostic Systems, Inc. · Aug 1986
SERALYZER TOTAL BILIRUBIN CALIBRATORS
K855040 · Miles Laboratories, Inc. · Jan 1986
ROCHE STANDARDS FOR CHOLESTEROL
K843110 · Roche Diagnostic Systems, Inc. · Sep 1984
DUPONT ACA MAGNESIUM CALIBRATOR
K841955 · E.I. Dupont DE Nemours & Co., Inc. · Jun 1984
PRECISET CHOLESTEROL HIGH PERFORM
K832251 · Boehringer Mannheim Corp. · Aug 1983