Cleared Traditional

K861098 - SEROIDEN STREPTO KIT 'EIKEN'

K861098 is the FDA 510(k) clearance for SEROIDEN STREPTO KIT 'EIKEN' by Syn-Kit, Inc.. It is a Class 1 Microbiology device (product code GTZ) cleared through the Traditional 510(k) pathway after a 141-day FDA review.

K861098 · Syn-Kit, Inc. · Microbiology device
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Aug 1986
Decision
141d
Days
Class 1
Risk

K861098 is an FDA 510(k) clearance for the SEROIDEN STREPTO KIT 'EIKEN'. Classified as Antisera, All Groups, Streptococcus Spp. (product code GTZ), Class I - General Controls.

Submitted by Syn-Kit, Inc. (Chatsworth, US). The FDA issued a Cleared decision on August 12, 1986 after a review of 141 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3740 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Syn-Kit, Inc. devices

Submission Details

510(k) Number K861098 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 1986
Decision Date August 12, 1986
Days to Decision 141 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
39d slower than avg
Panel avg: 102d · This submission: 141d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GTZ Antisera, All Groups, Streptococcus Spp.
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3740
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 - GTZ Antisera, All Groups, Streptococcus Spp.

All 62
Devices cleared under the same product code (GTZ) and FDA review panel - the closest regulatory comparables to K861098.
BACTO(R) STREP GROUP KIT
K870854 · Difco Laboratories, Inc. · Apr 1987
DIRECTIGEN MENINGITIS COMBO TEST & (B) STREP TEST
K870155 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Mar 1987
LEECO VIS-CUBE STREP A (EIA)
K864170 · Leeco Diagnostics, Inc. · Feb 1987
DIRECTIGEN COMBO MENINGITIS TEST
K860768 · Bd Becton Dickinson Vacutainer Systems Preanalytic · May 1986
LEECO-SCREEN, STREP A (EIA)
K860947 · Leeco Diagnostics, Inc. · May 1986
TANDEM ICON STREP A IMMUNOENZYMETRIC ASSAY KIT
K860778 · Hybritech, Inc. · Apr 1986