Cleared Traditional

K831600 - DIASTIX REAGENT STRIPS FOR URINALYSIS

K831600 is an FDA 510(k) clearance for DIASTIX REAGENT STRIPS FOR URINALYSIS, manufactured by Miles Laboratories, Inc.. The device is a Class 2 Chemistry device with 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

FDA 510(k) Submission Details - K831600

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.

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 49
Devices cleared under the same product code (JIL) and FDA review panel - the closest regulatory comparables to K831600.
UROPAPER EIKEN GK
K843758 · Syn-Kit, Inc. · Dec 1984
UROPAPER EIKEN HAG
K843759 · Syn-Kit, Inc. · Dec 1984
UROPAPER EIKEN G
K843760 · Syn-Kit, Inc. · Dec 1984
BIOSTRIP G
K820594 · Helena Laboratories · May 1982
UROPAPER EIKEN UHAG
K811816 · Syn-Kit, Inc. · Dec 1981
UROPAPER EIKEN UAG
K811818 · Syn-Kit, Inc. · Jul 1981