Cleared Traditional

K861255 - BEHRING RAPIGNOST TOTAL SCREEN L URINE ...

K861255 is the FDA 510(k) clearance for BEHRING RAPIGNOST TOTAL SCREEN L URINE ... by Behring Diagnostics, Inc.. It is a Class 2 Chemistry device (product code JIL) cleared through the Traditional 510(k) pathway after a 183-day FDA review.

K861255 · Behring Diagnostics, Inc. · Chemistry device
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Oct 1986
Decision
183d
Days
Class 2
Risk

K861255 is an FDA 510(k) clearance for the BEHRING RAPIGNOST TOTAL SCREEN L URINE TEST STRIPS. Classified as Method, Enzymatic, Glucose (urinary, Non-quantitative) (product code JIL), Class II - Special Controls.

Submitted by Behring Diagnostics, Inc. (La Jolla, US). The FDA issued a Cleared decision on October 3, 1986 after a review of 183 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 Behring Diagnostics, Inc. devices

Submission Details

510(k) Number K861255 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 1986
Decision Date October 03, 1986
Days to Decision 183 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
95d slower than avg
Panel avg: 88d · This submission: 183d
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 34
Devices cleared under the same product code (JIL) and FDA review panel - the closest regulatory comparables to K861255.
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
BIOTEL (TM)/ DIABETES
K855239 · American Diagnostic Corp. · Jun 1986
UROPAPER EIKEN GP
K843753 · Syn-Kit, Inc. · Dec 1984
UROPAPER EIKEN 7
K843754 · Syn-Kit, Inc. · Dec 1984