Cleared Traditional

K861631 - SLIDE CULTURE U 'EIKEN'

K861631 is the FDA 510(k) clearance for SLIDE CULTURE U 'EIKEN' by Syn-Kit, Inc.. It is a Class 1 Microbiology device (product code JXA) cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K861631 · Syn-Kit, Inc. · Microbiology device
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Jun 1986
Decision
42d
Days
Class 1
Risk

K861631 is an FDA 510(k) clearance for the SLIDE CULTURE U 'EIKEN'. Classified as Kit, Screening, Urine (product code JXA), Class I - General Controls.

Submitted by Syn-Kit, Inc. (Chatsworth, US). The FDA issued a Cleared decision on June 10, 1986 after a review of 42 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 Syn-Kit, Inc. devices

Submission Details

510(k) Number K861631 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 1986
Decision Date June 10, 1986
Days to Decision 42 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
60d faster than avg
Panel avg: 102d · This submission: 42d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JXA Kit, Screening, Urine
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 - JXA Kit, Screening, Urine

All 10
Devices cleared under the same product code (JXA) and FDA review panel - the closest regulatory comparables to K861631.
BAC-T-SCREEN
K924218 · Biomerieux Vitek, Inc. · Feb 1993
GEN-PROBE PACE SYSTEM URINE SCREEN
K892216 · Gen-Probe, Inc. · Sep 1989
URICHECK
K860905 · Difco Laboratories, Inc. · Apr 1986
BAC-T-SCREEN
K851399 · Marion Laboratories, Inc. · Jun 1985
ORTHO BACTERIURIA DETECTION SYS
K833834 · Ortho Diagnostic Systems, Inc. · Mar 1984
DIPCHEX DIP-SLIDE CULTURE SYS
K830252 · Granite Diagnostics, Inc. · Mar 1983