Cleared Traditional

K855239 - BIOTEL (TM)/ DIABETES

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

K855239 · American Diagnostic Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K855239

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
Combination Product No
PCCP Authorized No
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.

JIL Device Classification - Class 2, Special Controls

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 40
Devices cleared under the same product code (JIL) and FDA review panel - the closest regulatory comparables to K855239.
CHEMSTRIP(R) 10 WITH SG URINE TEST STRIPS
K896454 · Boehringer Mannheim Corp. · Jan 1990
MAJOR QUALITY GLUCOSE AND KETONES URINE TEST
K870500 · American Diagnostic Corp. · Mar 1987
BEHRING RAPIGNOST TOTAL SCREEN L URINE TEST STRIPS
K861255 · Behring Diagnostics, Inc. · Oct 1986
UROPAPER EIKEN GP
K843753 · Syn-Kit, Inc. · Dec 1984
UROPAPER EIKEN 7
K843754 · Syn-Kit, Inc. · Dec 1984
UROPAPER EIKEN 6B
K843755 · Syn-Kit, Inc. · Dec 1984