Cleared Traditional

K924926 - MSI-HCT

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

K924926 · Medical Specialties, Inc. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K924926

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.

GLK Device Classification - Class 2, Special Controls

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.
AALTO SCIENTIFIC MIRCO HEMATOCRIT CONTROL
K020618 · Aalto Scientific, Ltd. · May 2002
HEMATACHEK
K964452 · Richmond Diagnostics, Inc. · Feb 1997
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