Cleared Traditional

K931862 - NINHYDRIN REAGENT

K931862 is the FDA 510(k) clearance for NINHYDRIN REAGENT by Hardy Diagnostics. It is a Class 1 Microbiology device (product code JTO) cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K931862 · Hardy Diagnostics · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1993
Decision
62d
Days
Class 1
Risk

K931862 is an FDA 510(k) clearance for the NINHYDRIN REAGENT. Classified as Discs, Strips And Reagents, Microorganism Differentiation (product code JTO), Class I - General Controls.

Submitted by Hardy Diagnostics (Santa Maria, US). The FDA issued a Cleared decision on June 15, 1993 after a review of 62 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 Hardy Diagnostics devices

Submission Details

510(k) Number K931862 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 1993
Decision Date June 15, 1993
Days to Decision 62 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 102d · This submission: 62d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 144
Devices cleared under the same product code (JTO) and FDA review panel - the closest regulatory comparables to K931862.
BACTICARD E. COLI
K934986 · Remel Co. · Feb 1994
PYR TEST KIT
K931865 · Hardy Diagnostics · Dec 1993
BACTICARD STREP
K933514 · Remel Co. · Oct 1993
OXYSTRIP
K930693 · Hardy Diagnostics · May 1993
CATALASE REAGENT
K931414 · Hardy Diagnostics · May 1993
BACTIDROP(TM) MUCAP
K930878 · Remel Co. · May 1993