Cleared Traditional

K880038 - FOR THE DETER. OF HEMOGLOBIN IN PLASMA #527

K880038 is an FDA 510(k) clearance for FOR THE DETER. OF HEMOGLOBIN IN PLASMA #527, manufactured by Sigma Diagnostics, Inc.. The device is a Class 2 Hematology device with product code KHG cleared through the Traditional 510(k) pathway after a 107-day FDA review.

K880038 · Sigma Diagnostics, Inc. · Hematology device
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Apr 1988
Decision
107d
Days
Class 2
Risk

K880038 is an FDA 510(k) clearance for the FOR THE DETER. OF HEMOGLOBIN IN PLASMA #527. Classified as Whole Blood Hemoglobin Determination (product code KHG), Class II - Special Controls.

Submitted by Sigma Diagnostics, Inc. (St. Louis, US). The FDA issued a Cleared decision on April 21, 1988 after a review of 107 days - within the typical 510(k) review window.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7500 - the FDA hematology 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 Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all Sigma Diagnostics, Inc. devices

FDA 510(k) Submission Details - K880038

510(k) Number K880038 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 05, 1988
Decision Date April 21, 1988
Days to Decision 107 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
6d faster than avg
Panel avg: 113d · This submission: 107d
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 Hematology 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 K880038.
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
EASY-TEST HEMOGLOBIN (HGB) ITEM #16685
K872653 · Em Diagnostic Systems, Inc. · Jul 1987
HAEMOGLOBIN REAGENT - CYANMETHAEMOGLOBIN METHOD
K870363 · Trace Scientific , Ltd. · Mar 1987
TOTAL HEMOGLOBIN
K863104 · J. D. Assoc. · Sep 1986