Cleared Traditional

ACCU-CHEK II LOW AND HIGH GLUCOSE CONTROL (K855225) - FDA 510(k) Clearance

Class I Chemistry device.

K855225 · Boehringer Mannheim Corp. · Chemistry device
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Jan 1986
Decision
18d
Days
Class 1
Risk

K855225 is an FDA 510(k) clearance for the ACCU-CHEK II LOW AND HIGH GLUCOSE CONTROL. Classified as Single (specified) Analyte Controls (assayed And Unassayed) (product code JJX), Class I - General Controls.

Submitted by Boehringer Mannheim Corp. (Indianapolis, US). The FDA issued a Cleared decision on January 17, 1986 after a review of 18 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

Submission Details

510(k) Number K855225 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 30, 1985
Decision Date January 17, 1986
Days to Decision 18 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
70d faster than avg
Panel avg: 88d · This submission: 18d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 194
Devices cleared under the same product code (JJX) and FDA review panel - the closest regulatory comparables to K855225.
TESTPACK ACUTE HCG SERUM CONTROLS
K863126 · Abbott Laboratories · Sep 1986
EASY-TEST CHEK (INSTRUM. CHECK) & EMDS ABS TEST
K861221 · Em Diagnostic Systems, Inc. · Apr 1986
ACE CONTROLS, NORMAL & ELEVATED, NO. A6040 & A7040
K860453 · Sigma Diagnostics, Inc. · Feb 1986
BECKMAN TRIGLYCERIDES CONTROL LEVELS 1/2 &3
K851079 · Beckman Instruments, Inc. · Apr 1985
PRECISET AMMONIA
K843569 · Boehringer Mannheim Corp. · Sep 1984
FETAL-TEK CONTROL (IMMATURE/BORDERLINE)
K820772 · Helena Laboratories · May 1982