Cleared Traditional

K913005 - BACTIDROP(TM) LACTOPHENOL ANILINE BLUE

K913005 is an FDA 510(k) clearance for BACTIDROP(TM) LACTOPHENOL ANILINE BLUE, manufactured by Remel Co.. The device is a Class 2 Hematology device with product code JIO cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K913005 · Remel Co. · Hematology device
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Sep 1991
Decision
70d
Days
Class 2
Risk

K913005 is an FDA 510(k) clearance for the BACTIDROP(TM) LACTOPHENOL ANILINE BLUE. Classified as Blood, Occult, Colorimetric, In Urine (product code JIO), Class II - Special Controls.

Submitted by Remel Co. (Lenexa, US). The FDA issued a Cleared decision on September 16, 1991 after a review of 70 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.6550 - the FDA hematology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Remel Co. devices

FDA 510(k) Submission Details - K913005

510(k) Number K913005 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 08, 1991
Decision Date September 16, 1991
Days to Decision 70 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
43d faster than avg
Panel avg: 113d · This submission: 70d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JIO Device Classification - Class 2, Special Controls

Product Code JIO Blood, Occult, Colorimetric, In Urine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.6550
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 Hematology devices follow this clearance model.

Regulatory Peers - JIO Blood, Occult, Colorimetric, In Urine

Devices cleared under the same product code (JIO) and FDA review panel - the closest regulatory comparables to K913005.
HEALGEN 11 REAGENT STRIP FOR URINALYSIS, HEALGEN 10 REAGENT STRIP FOR URINALYSIS, AND HEALGEN 4 REAGENT STRIP FOR URINAL
K111999 · Healgen Scientific, LLC · Apr 2012
MISSION U500 URINE ANALYZER
K111221 · ACON Laboratories, Inc. · Jan 2012
URS-1B (BLOOD TEST)
K023297 · Teco Diagnostics · Mar 2003
HEMASTIX REAGENT STRIPS
K905396 · Heraeus Kulzer, Inc. · Feb 1991