Cleared Traditional

K940840 - ACT CONTROL SET

K940840 is an FDA 510(k) clearance for ACT CONTROL SET, manufactured by Sigma Diagnostics, Inc.. The device is a Class 2 Hematology device with product code JPA cleared through the Traditional 510(k) pathway after a 146-day FDA review.

K940840 · Sigma Diagnostics, Inc. · Hematology device
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Jul 1994
Decision
146d
Days
Class 2
Risk

K940840 is an FDA 510(k) clearance for the ACT CONTROL SET. Classified as System, Multipurpose For In Vitro Coagulation Studies (product code JPA), Class II - Special Controls.

Submitted by Sigma Diagnostics, Inc. (St. Louis, US). The FDA issued a Cleared decision on July 19, 1994 after a review of 146 days - within the typical 510(k) review window.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5425 - 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 - K940840

510(k) Number K940840 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 1994
Decision Date July 19, 1994
Days to Decision 146 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
33d slower than avg
Panel avg: 113d · This submission: 146d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JPA Device Classification - Class 2, Special Controls

Product Code JPA System, Multipurpose For In Vitro Coagulation Studies
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5425
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 - JPA System, Multipurpose For In Vitro Coagulation Studies

All 158
Devices cleared under the same product code (JPA) and FDA review panel - the closest regulatory comparables to K940840.
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JR. MICROCOAGULATION SYSTEM
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R & D BATTERIES, INC. PART NUMBERS 5296, 5479, 5351, & 5470
K934747 · R & D Batteries, Inc. · Dec 1993