Cleared Traditional

K864544 - DIABETES RISK DETECTOR

K864544 is an FDA 510(k) clearance for DIABETES RISK DETECTOR, manufactured by Pearce Clinical Laboratories, Inc.. The device is a Class 2 Chemistry device with 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.

FDA 510(k) Submission Details - K864544

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
161d slower than avg
Panel avg: 89d · This submission: 250d
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 80
Devices cleared under the same product code (JIL) and FDA review panel - the closest regulatory comparables to K864544.
UROPAPER EIKEN 7
K932369 · Tanabe U.S.A., Inc. · Nov 1993
CHEMSTRIP(R) 10 WITH SG URINE TEST STRIPS
K896454 · Boehringer Mannheim Corp. · Jan 1990
CHARISE CHARLES REAGENT STRIPS
K895282 · Lee Import Domestic Consulting · 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
ADDITIONAL KYOTEST URINE TEST REAGENT STRIPS
K861733 · Kyoto Diagnostics, Inc. · Jul 1986
K864544 · DIABETES RISK DETECTOR
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