Cleared Traditional

K955283 - PRIMUS VARIANT SYSTEM PVS99

K955283 is the FDA 510(k) clearance for PRIMUS VARIANT SYSTEM PVS99 by Primus Corp.. It is a Class 2 Hematology device (product code GKA) cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K955283 · Primus Corp. · Hematology device
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Mar 1996
Decision
106d
Days
Class 2
Risk

K955283 is an FDA 510(k) clearance for the PRIMUS VARIANT SYSTEM PVS99. Classified as Abnormal Hemoglobin Quantitation (product code GKA), Class II - Special Controls.

Submitted by Primus Corp. (Kansas City, US). The FDA issued a Cleared decision on March 1, 1996 after a review of 106 days - within the typical 510(k) review window.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7415 - 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

Submission Details

510(k) Number K955283 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 1995
Decision Date March 01, 1996
Days to Decision 106 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
7d faster than avg
Panel avg: 113d · This submission: 106d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GKA Abnormal Hemoglobin Quantitation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7415
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 - GKA Abnormal Hemoglobin Quantitation

All 14
Devices cleared under the same product code (GKA) and FDA review panel - the closest regulatory comparables to K955283.
Hemoglobin Variants System on Newborn Hemoglobin System with GDM and HbReview Software
K171664 · Bio-Rad Laboratories, Inc. · Sep 2017
BIO-RAD VARIANT NBS SICKLE CELL PROGRAM
K051072 · Bio-Rad Laboratories, Inc. · May 2005
VARIANT ALPHA-THALASSEMIA SHORT PROGRAM
K955355 · Bio-Rad · Apr 1996
VARIANT HEMOGLOBINOPATHY PROGRAM
K954048 · Bio-Rad · Nov 1995
VARIANT SICKLE CELL SHORT PROGRAM
K924813 · Bio-Rad · Jan 1993
PARAGON ACID HEMOGLOBIN REAGENT KIT
K834595 · Beckman Instruments, Inc. · May 1984