Cleared Traditional

K854223 - VES-TEC/VES-MATIC

K854223 is an FDA 510(k) clearance for VES-TEC/VES-MATIC, manufactured by Marvic Interpharma, Inc.. The device is a Class 2 Hematology device with product code CKB cleared through the Traditional 510(k) pathway after a 168-day FDA review.

K854223 · Marvic Interpharma, Inc. · Hematology device
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Apr 1986
Decision
168d
Days
Class 2
Risk

K854223 is an FDA 510(k) clearance for the VES-TEC/VES-MATIC. Classified as Acid Phosphatase, Naphthyl Phosphate (product code CKB), Class II - Special Controls.

Submitted by Marvic Interpharma, Inc. (Palm Harbor, US). The FDA issued a Cleared decision on April 4, 1986 after a review of 168 days - an extended review cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 862.1020 - 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 Marvic Interpharma, Inc. devices

FDA 510(k) Submission Details - K854223

510(k) Number K854223 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 1985
Decision Date April 04, 1986
Days to Decision 168 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
55d slower than avg
Panel avg: 113d · This submission: 168d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CKB Device Classification - Class 2, Special Controls

Product Code CKB Acid Phosphatase, Naphthyl Phosphate
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1020
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 - CKB Acid Phosphatase, Naphthyl Phosphate

All 22
Devices cleared under the same product code (CKB) and FDA review panel - the closest regulatory comparables to K854223.
ACID PHOSPHATASE (KINETIC) CAT. # 320-06
K875209 · Diagnostic Chemicals, Ltd. (Usa) · Feb 1988
ACID PHOSPHATASE (ACP) REAGENT
K863851 · Sigma Diagnostics, Inc. · Oct 1986
ACID PHOSPHATASE PROCEDURE
K861675 · Data Medical Associates, Inc. · May 1986
DEMAND ACID PHOSPHATASE REAGENT
K853949 · Cooper Biomedical, Inc. · Oct 1985
DATA ZYME ACID PHOSPHATASE PROCEDURE
K850902 · Data Medical Associates, Inc. · Mar 1985
PARAMAX ACID PHOSPHATASE REAGENT
K840661 · American Dade · Apr 1984