Cleared Traditional

K861888 - HIPPURATE HYDROLYSIS TEST

K861888 is an FDA 510(k) clearance for HIPPURATE HYDROLYSIS TEST, manufactured by Pro-Lab, Inc.. The device is a Class 1 Microbiology device with product code JTO cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K861888 · Pro-Lab, Inc. · Microbiology device
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Jun 1986
Decision
18d
Days
Class 1
Risk

K861888 is an FDA 510(k) clearance for the HIPPURATE HYDROLYSIS TEST. Classified as Discs, Strips And Reagents, Microorganism Differentiation (product code JTO), Class I - General Controls.

Submitted by Pro-Lab, Inc. (Ontario Canada M5m 1c9, CA). The FDA issued a Cleared decision on June 3, 1986 after a review of 18 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2660 - the FDA microbiology 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 Pro-Lab, Inc. devices

FDA 510(k) Submission Details - K861888

510(k) Number K861888 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 1986
Decision Date June 03, 1986
Days to Decision 18 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
84d faster than avg
Panel avg: 102d · This submission: 18d
Pathway characteristics
Predicate-based equivalence.

JTO Device Classification - Class 1, General Controls

Product Code JTO Discs, Strips And Reagents, Microorganism Differentiation
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2660
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - JTO Discs, Strips And Reagents, Microorganism Differentiation

All 196
Devices cleared under the same product code (JTO) and FDA review panel - the closest regulatory comparables to K861888.
ONPG SOLUTION
K863601 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1986
NEIS NZY
K863216 · Carr-Scarborough Microbiologicals, Inc. · Sep 1986
DISPENS-O-DISC DIFFERENTIATION DISKS PYR
K862570 · Difco Laboratories, Inc. · Jul 1986
D'ALA RAPID TEST
K861889 · Pro-Lab, Inc. · Jun 1986
SENSITITRE AUTO ID PLATE, AP70
K861058 · Gibco Laboratories Life Technologies, Inc. · May 1986
MACCONKEY W/MUG
K861259 · Remel Co. · Apr 1986