Cleared Traditional

K983599 - SAFETEX CHLAMYDIA TRACHOMATIS SPECIMEN COLLECTION KIT

K983599 is an FDA 510(k) clearance for SAFETEX CHLAMYDIA TRACHOMATIS SPECIMEN ..., manufactured by Andwin Scientific. The device is a Class 2 Microbiology device with product code HHT cleared through the Traditional 510(k) pathway after a 58-day FDA review.

K983599 · Andwin Scientific · Microbiology device
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Dec 1998
Decision
58d
Days
Class 2
Risk

K983599 is an FDA 510(k) clearance for the SAFETEX CHLAMYDIA TRACHOMATIS SPECIMEN COLLECTION KIT. Classified as Spatula, Cervical, Cytological (product code HHT), Class II - Special Controls.

Submitted by Andwin Scientific (Woodland Hills, US). The FDA issued a Cleared decision on December 11, 1998 after a review of 58 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 884.4530 - 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 Andwin Scientific devices

FDA 510(k) Submission Details - K983599

510(k) Number K983599 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 14, 1998
Decision Date December 11, 1998
Days to Decision 58 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
44d faster than avg
Panel avg: 102d · This submission: 58d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HHT Device Classification - Class 2, Special Controls

Product Code HHT Spatula, Cervical, Cytological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.4530
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Microbiology devices follow this clearance model.

Regulatory Peers - HHT Spatula, Cervical, Cytological

All 20
Devices cleared under the same product code (HHT) and FDA review panel - the closest regulatory comparables to K983599.
exCellerator Cervical Collection Device
K182049 · Excell Company, LLC · Apr 2019
HARWILL MEDICAL CERVITULA CERVICAL SPATULA
K983202 · Harwill Medical (Pty) , Ltd. · Mar 1999
SAFETEX CERVICAL SCRAPER (PLASTIC)
K983428 · Andwin Scientific · Nov 1998
CERVICAL CYTOLOGY C-BRUSH MODEL CMB-1010
K980356 · Canadian Medical Brush, Inc. · Apr 1998
DIGENE CERVICAL BRUSH
K971586 · Digene Corp. · Sep 1997
CYTOLOGY BRUSH
K971849 · Team Technologies, Inc. · Jul 1997