Cleared Traditional

K924926 - MSI-HCT

K924926 is the FDA 510(k) clearance for MSI-HCT by Medical Specialties, Inc.. It is a Class 2 Hematology device (product code GLK) cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K924926 · Medical Specialties, Inc. · Hematology device
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Jan 1993
Decision
99d
Days
Class 2
Risk

K924926 is an FDA 510(k) clearance for the MSI-HCT. Classified as Control, Hematocrit (product code GLK), Class II - Special Controls.

Submitted by Medical Specialties, Inc. (South Plainfield, US). The FDA issued a Cleared decision on January 7, 1993 after a review of 99 days - within the typical 510(k) review window.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.8625 - 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 Medical Specialties, Inc. devices

Submission Details

510(k) Number K924926 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 1992
Decision Date January 07, 1993
Days to Decision 99 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
14d faster than avg
Panel avg: 113d · This submission: 99d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GLK Control, Hematocrit
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.8625
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 - GLK Control, Hematocrit

Devices cleared under the same product code (GLK) and FDA review panel - the closest regulatory comparables to K924926.
MEDICA EASYQC HEMATOCRIT CONTROL
K021924 · Bionostics, Inc. · Jun 2002
AALTO SCIENTIFIC MIRCO HEMATOCRIT CONTROL
K020618 · Aalto Scientific, Ltd. · May 2002
CERTAIN HCT LEVEL A & LEVEL B/CVM HCT LEVELS 1,2,3, & 4
K961807 · Ciba Corning Diagnostics Corp. · Jul 1996
A.QC HCT LEVEL 1 AND 2
K893562 · Johnson & Johnson Professionals, Inc. · Jul 1989