Cleared Traditional

K960997 - STARSWAB CULTURE COLLECTION AND TRANSPORT SYSTEM

K960997 is an FDA 510(k) clearance for STARSWAB CULTURE COLLECTION AND TRANSPO..., manufactured by Starplex Scientific, Inc.. The device is a Class 1 Microbiology device with product code LIO cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K960997 · Starplex Scientific, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1996
Decision
22d
Days
Class 1
Risk

K960997 is an FDA 510(k) clearance for the STARSWAB CULTURE COLLECTION AND TRANSPORT SYSTEM. Classified as Device, Specimen Collection (product code LIO), Class I - General Controls.

Submitted by Starplex Scientific, Inc. (Etobicoke, Ontario, CA). The FDA issued a Cleared decision on April 3, 1996 after a review of 22 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2900 - 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 Starplex Scientific, Inc. devices

FDA 510(k) Submission Details - K960997

510(k) Number K960997 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 1996
Decision Date April 03, 1996
Days to Decision 22 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
80d faster than avg
Panel avg: 102d · This submission: 22d
Pathway characteristics
Predicate-based equivalence.

LIO Device Classification - Class 1, General Controls

Product Code LIO Device, Specimen Collection
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2900
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 - LIO Device, Specimen Collection

All 33
Devices cleared under the same product code (LIO) and FDA review panel - the closest regulatory comparables to K960997.
STP SYSTEM PVA WITH ZINC
K963986 · Sage Products, Inc. · Nov 1996
STP SYSTEM - SAF
K964026 · Sage Products, Inc. · Nov 1996
STP SYSTEM-PVA WITH MERCURY
K964027 · Sage Products, Inc. · Nov 1996
MID-STREAM COLLECTION SET-STERILE
K953929 · Trinity Laboratories, Inc. · Nov 1995
ZINC PVA
K931383 · Remel Co. · Jun 1993
PARA-PAK PLUS
K931770 · Meridian Diagnostics, Inc. · Jun 1993