Cleared Traditional

K864544 - DIABETES RISK DETECTOR

K864544 is the FDA 510(k) clearance for DIABETES RISK DETECTOR by Pearce Clinical Laboratories, Inc.. It is a Class 2 Chemistry device (product code JIL) cleared through the Traditional 510(k) pathway after a 250-day FDA review.

K864544 · Pearce Clinical Laboratories, Inc. · Chemistry device
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Jul 1987
Decision
250d
Days
Class 2
Risk

K864544 is an FDA 510(k) clearance for the DIABETES RISK DETECTOR. Classified as Method, Enzymatic, Glucose (urinary, Non-quantitative) (product code JIL), Class II - Special Controls.

Submitted by Pearce Clinical Laboratories, Inc. (Conroe, US). The FDA issued a Cleared decision on July 27, 1987 after a review of 250 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 Pearce Clinical Laboratories, Inc. devices

Submission Details

510(k) Number K864544 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 1986
Decision Date July 27, 1987
Days to Decision 250 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
162d slower than avg
Panel avg: 88d · This submission: 250d
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 38
Devices cleared under the same product code (JIL) and FDA review panel - the closest regulatory comparables to K864544.
IN VITRO DIAGNOSTIC URINE REAGENT STRIPS SET
K942648 · Teco Diagnostics · Mar 1995
URINE REAGENT STRIP-3 PARAMETERS
K940469 · Teco Diagnostics · Sep 1994
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
BIOTEL (TM)/ DIABETES
K855239 · American Diagnostic Corp. · Jun 1986