Cleared Traditional

K940008 - GLYCATED PROTEIN CALIBRATORS

K940008 is an FDA 510(k) clearance for GLYCATED PROTEIN CALIBRATORS, manufactured by Primus Corp.. The device is a Class 2 Hematology device with product code JIS cleared through the Traditional 510(k) pathway after a 125-day FDA review.

K940008 · Primus Corp. · Hematology device
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May 1994
Decision
125d
Days
Class 2
Risk

K940008 is an FDA 510(k) clearance for the GLYCATED PROTEIN CALIBRATORS. Classified as Calibrator, Primary (product code JIS), Class II - Special Controls.

Submitted by Primus Corp. (Kansas City, US). The FDA issued a Cleared decision on May 9, 1994 after a review of 125 days - within the typical 510(k) review window.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 862.1150 - 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 - K940008

510(k) Number K940008 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 04, 1994
Decision Date May 09, 1994
Days to Decision 125 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
12d slower than avg
Panel avg: 113d · This submission: 125d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JIS Device Classification - Class 2, Special Controls

Product Code JIS Calibrator, Primary
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1150
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 - JIS Calibrator, Primary

All 113
Devices cleared under the same product code (JIS) and FDA review panel - the closest regulatory comparables to K940008.
T-UPTAKE CALIBRATORS
K951585 · Diagnostic Reagents, Inc. · Jun 1995
IMX ESTRADIOL
K951629 · Abbott Laboratories · May 1995
CALIBRATORS
K944701 · Diagnostic Reagents, Inc. · Nov 1994
URINARY ALBUMIN CALIBRATOR
K936201 · Dupont Medical Products · Mar 1994
KING SODIUM/POTASSIUM STANDARD MODIFIED
K931834 · King Diagnostics, Inc. · Aug 1993
DC-LINEATE CAT. NO. SE-091
K932555 · Diagnostic Chemicals, Ltd. (Usa) · Aug 1993