Cleared Traditional

K813164 - SYSTEK #1 EIKEN

K813164 is the FDA 510(k) clearance for SYSTEK #1 EIKEN by Syn-Kit, Inc.. It is a Class 1 Microbiology device (product code JSS) cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K813164 · Syn-Kit, Inc. · Microbiology device
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Dec 1981
Decision
51d
Days
Class 1
Risk

K813164 is an FDA 510(k) clearance for the SYSTEK #1 EIKEN. Classified as Kit, Identification, Enterobacteriaceae (product code JSS), Class I - General Controls.

Submitted by Syn-Kit, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 31, 1981 after a review of 51 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 K813164 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 10, 1981
Decision Date December 31, 1981
Days to Decision 51 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
51d faster than avg
Panel avg: 102d · This submission: 51d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JSS Kit, Identification, Enterobacteriaceae
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 - JSS Kit, Identification, Enterobacteriaceae

All 23
Devices cleared under the same product code (JSS) and FDA review panel - the closest regulatory comparables to K813164.
SPECTRUM-10
K831672 · Austin Biological Laboratories · Jun 1983
QUANTUM II BACTERIAL IDENT. SYSTEM
K830698 · Abbott Laboratories · Apr 1983
UREA-PDA DISK
K830396 · Remel Co. · Mar 1983
MINITECK ENTERIC BROTH & ENTEROBACTER
K812286 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 1981
SENSITITIRE AP60
K811765 · Gibco Laboratories Life Technologies, Inc. · Aug 1981
SCEPTOR ID GRAM NEGATIVE MIC/ID PANELS
K811434 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jun 1981