Cleared Traditional

K871835 - GLUCOMETER QC BLOOD METER

K871835 is the FDA 510(k) clearance for GLUCOMETER QC BLOOD METER by Miles Laboratories, Inc.. It is a Class 2 Chemistry device (product code CGA) cleared through the Traditional 510(k) pathway after a 225-day FDA review.

K871835 · Miles Laboratories, Inc. · Chemistry device
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Dec 1987
Decision
225d
Days
Class 2
Risk

K871835 is an FDA 510(k) clearance for the GLUCOMETER QC BLOOD METER, AMES GLUCO SYSTEM PRINT. Classified as Glucose Oxidase, Glucose (product code CGA), Class II - Special Controls.

Submitted by Miles Laboratories, Inc. (Elkhart, US). The FDA issued a Cleared decision on December 22, 1987 after a review of 225 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1345 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Miles Laboratories, Inc. devices

Submission Details

510(k) Number K871835 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 1987
Decision Date December 22, 1987
Days to Decision 225 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
137d slower than avg
Panel avg: 88d · This submission: 225d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CGA Glucose Oxidase, Glucose
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1345
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 - CGA Glucose Oxidase, Glucose

All 190
Devices cleared under the same product code (CGA) and FDA review panel - the closest regulatory comparables to K871835.
ACCUCHEK II FREEDOM(TM) MONITORING SYSTEM
K883817 · Boehringer Mannheim Corp. · Dec 1988
TRACER(TM) II BLOOD GLUCOSE SYSTEM
K881908 · Boehringer Mannheim Corp. · Jul 1988
GLUCOSE (TRINDER) CAT. # 220-32
K875211 · Diagnostic Chemicals, Ltd. (Usa) · Apr 1988
BIOTROL GLUCOSE ENZYMATIQUE COLOR REAGENT
K873117 · Biotrol, USA, Inc. · Aug 1987
MODIFICATION OF ACCU-CHEK II
K863481 · Boehringer Mannheim Corp. · Apr 1987
FAST GLUCOSE
K870631 · Sclavo, Inc. · Mar 1987