Cleared Traditional

K855239 - BIOTEL (TM)/ DIABETES

K855239 is the FDA 510(k) clearance for BIOTEL (TM)/ DIABETES by American Diagnostic Corp.. It is a Class 2 Chemistry device (product code JIL) cleared through the Traditional 510(k) pathway after a 164-day FDA review.

K855239 · American Diagnostic Corp. · Chemistry device
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Jun 1986
Decision
164d
Days
Class 2
Risk

K855239 is an FDA 510(k) clearance for the BIOTEL (TM)/ DIABETES. Classified as Method, Enzymatic, Glucose (urinary, Non-quantitative) (product code JIL), Class II - Special Controls.

Submitted by American Diagnostic Corp. (Wheaton, US). The FDA issued a Cleared decision on June 13, 1986 after a review of 164 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1340 - 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 American Diagnostic Corp. devices

Submission Details

510(k) Number K855239 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 31, 1985
Decision Date June 13, 1986
Days to Decision 164 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
76d slower than avg
Panel avg: 88d · This submission: 164d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JIL Method, Enzymatic, Glucose (urinary, Non-quantitative)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1340
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 - JIL Method, Enzymatic, Glucose (urinary, Non-quantitative)

All 17
Devices cleared under the same product code (JIL) and FDA review panel - the closest regulatory comparables to K855239.
URISYS 2400 URINE TEST STRIP
K012397 · Roche Diagnostics Corp. · Sep 2001
CHEMSTRIP(R) 10 WITH SG URINE TEST STRIPS
K896454 · Boehringer Mannheim Corp. · Jan 1990
BEHRING RAPIGNOST TOTAL SCREEN L URINE TEST STRIPS
K861255 · Behring Diagnostics, Inc. · Oct 1986
DIASTIX REAGENT STRIPS FOR URINALYSIS
K831600 · Miles Laboratories, Inc. · Sep 1983
BIOSTRIP G
K820594 · Helena Laboratories · May 1982
9-WAY URINE TEST WITH ASCORBIC
K771755 · Miles Laboratories, Inc. · Oct 1977