Cleared Traditional

K831600 - DIASTIX REAGENT STRIPS FOR URINALYSIS

K831600 is the FDA 510(k) clearance for DIASTIX REAGENT STRIPS FOR URINALYSIS by Miles Laboratories, Inc.. It is a Class 2 Chemistry device (product code JIL) cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K831600 · Miles Laboratories, Inc. · Chemistry device
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Sep 1983
Decision
113d
Days
Class 2
Risk

K831600 is an FDA 510(k) clearance for the DIASTIX REAGENT STRIPS FOR URINALYSIS. Classified as Method, Enzymatic, Glucose (urinary, Non-quantitative) (product code JIL), Class II - Special Controls.

Submitted by Miles Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 8, 1983 after a review of 113 days - within the typical 510(k) review window.

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 Miles Laboratories, Inc. devices

Submission Details

510(k) Number K831600 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 1983
Decision Date September 08, 1983
Days to Decision 113 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
25d slower than avg
Panel avg: 88d · This submission: 113d
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 26
Devices cleared under the same product code (JIL) and FDA review panel - the closest regulatory comparables to K831600.
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
BIOSTRIP G
K820594 · Helena Laboratories · May 1982
9-WAY URINE TEST WITH ASCORBIC
K771755 · Miles Laboratories, Inc. · Oct 1977
MEGA-DIASTIX
K761310 · Miles Laboratories, Inc. · Mar 1977