Cleared Traditional

K844581 - 80 MG/DL GLUCOSE CONTROL

K844581 is an FDA 510(k) clearance for 80 MG/DL GLUCOSE CONTROL, manufactured by Boehringer Mannheim Corp.. The device is a Class 2 Chemistry device with product code JIS cleared through the Traditional 510(k) pathway after a 19-day FDA review.

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

FDA 510(k) Submission Details - K844581

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.

JIS Device Classification - Class 2, Special Controls

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 96
Devices cleared under the same product code (JIS) and FDA review panel - the closest regulatory comparables to K844581.
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K855040 · Miles Laboratories, Inc. · Jan 1986
TOTAL BILIRUBIN STANDARDS
K852068 · Data Medical Associates, Inc. · May 1985
CHLORIDE STANDARD
K844235 · Shaban Mfg. Co. · Nov 1984
ROCHE STANDARDS FOR CHOLESTEROL
K843110 · Roche Diagnostic Systems, Inc. · Sep 1984
HICHEM ION 2/4 SERUM RANGE CALIBRATOR
K842449 · Hi Chem, Inc. · Aug 1984