Cleared Traditional

K940142 - GLYCATED PROTEIN CONTROLS

K940142 is an FDA 510(k) clearance for GLYCATED PROTEIN CONTROLS, manufactured by Primus Corp.. The device is a Class 1 Hematology device with product code JJX cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K940142 · Primus Corp. · Hematology device
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Apr 1994
Decision
105d
Days
Class 1
Risk

K940142 is an FDA 510(k) clearance for the GLYCATED PROTEIN CONTROLS. Classified as Single (specified) Analyte Controls (assayed And Unassayed) (product code JJX), Class I - General Controls.

Submitted by Primus Corp. (Kansas City, US). The FDA issued a Cleared decision on April 26, 1994 after a review of 105 days - within the typical 510(k) review window.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 862.1660 - 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 Primus Corp. devices

FDA 510(k) Submission Details - K940142

510(k) Number K940142 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 11, 1994
Decision Date April 26, 1994
Days to Decision 105 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
8d faster than avg
Panel avg: 113d · This submission: 105d
Pathway characteristics
Predicate-based equivalence.

JJX Device Classification - Class 1, General Controls

Product Code JJX Single (specified) Analyte Controls (assayed And Unassayed)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1660
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - JJX Single (specified) Analyte Controls (assayed And Unassayed)

All 446
Devices cleared under the same product code (JJX) and FDA review panel - the closest regulatory comparables to K940142.
AXSYM LUTEINIZING HORMONE (LH)
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GLUCOMETER ELITE LOW CONTROL
K940577 · Heraeus Kulzer, Inc. · Jun 1994
ASSURE URINE HCG CONTROL
K941130 · Quantimetrix Corp. · Jun 1994
ACS NORMAL ANGIOTENSIN CONVERTING ENZYME CONTROL
K940272 · Analytical Control Systems, Inc. · Apr 1994
DOCUMENT(R) ZERO
K940568 · Casco Standards · Apr 1994
CLEARVIEW POSITIVE AND NEGATIVE HCG URINE CONTROL SET
K934922 · Unipath , Ltd. · Dec 1993