Cleared Traditional

K973649 - HEMOSITE TEST SYSTEM

K973649 is an FDA 510(k) clearance for HEMOSITE TEST SYSTEM, manufactured by Gds Technology, LLC. The device is a Class 2 Microbiology device with product code KHG cleared through the Traditional 510(k) pathway after a 340-day FDA review.

K973649 · Gds Technology, LLC · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1998
Decision
340d
Days
Class 2
Risk

K973649 is an FDA 510(k) clearance for the HEMOSITE TEST SYSTEM. Classified as Whole Blood Hemoglobin Determination (product code KHG), Class II - Special Controls.

Submitted by Gds Technology, LLC (Elkhart, US). The FDA issued a Cleared decision on August 31, 1998 after a review of 340 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 864.7500 - 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. Elevated predicate reliance profile. 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 Gds Technology, LLC devices

FDA 510(k) Submission Details - K973649

510(k) Number K973649 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 1997
Decision Date August 31, 1998
Days to Decision 340 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
238d slower than avg
Panel avg: 102d · This submission: 340d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KHG Device Classification - Class 2, Special Controls

Product Code KHG Whole Blood Hemoglobin Determination
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7500
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 - KHG Whole Blood Hemoglobin Determination

All 30
Devices cleared under the same product code (KHG) and FDA review panel - the closest regulatory comparables to K973649.
ANEMIAPRO SELF-SCREENER
K042379 · Biosafe Laboratories, Inc. · Dec 2004
CARESIDE HEMOGLOBIN
K001462 · Careside, Inc. · Aug 2000
HEMOSITE TEST SYSTEM
K994073 · Gds Technology, LLC · Jan 2000
ABBOTT VISION HEMOGLOBIN (MODIFICATION)
K953221 · Abbott Laboratories · Sep 1995
REFLOTRON HEMOGLOBIN TEST TABS
K934064 · Boehringer Mannheim Corp. · Dec 1993
CLINISTAT HEMOGLOBIN REAGENT TEST
K885227 · Heraeus Kulzer, Inc. · Feb 1989