Cleared Traditional

K834595 - PARAGON ACID HEMOGLOBIN REAGENT KIT

K834595 is an FDA 510(k) clearance for PARAGON ACID HEMOGLOBIN REAGENT KIT, manufactured by Beckman Instruments, Inc.. The device is a Class 2 Hematology device with product code GKA cleared through the Traditional 510(k) pathway after a 129-day FDA review.

K834595 · Beckman Instruments, Inc. · Hematology device
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May 1984
Decision
129d
Days
Class 2
Risk

K834595 is an FDA 510(k) clearance for the PARAGON ACID HEMOGLOBIN REAGENT KIT. Classified as Abnormal Hemoglobin Quantitation (product code GKA), Class II - Special Controls.

Submitted by Beckman Instruments, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 7, 1984 after a review of 129 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 Beckman Instruments, Inc. devices

FDA 510(k) Submission Details - K834595

510(k) Number K834595 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 30, 1983
Decision Date May 07, 1984
Days to Decision 129 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
16d slower than avg
Panel avg: 113d · This submission: 129d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GKA Device Classification - Class 2, Special Controls

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 18
Devices cleared under the same product code (GKA) and FDA review panel - the closest regulatory comparables to K834595.
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
RESOLVE-HB
K840011 · Isolab, Inc. · Feb 1984
ISOPROPANOL HEMOGLOBIN STABILITY TEST
K822123 · Helena Laboratories · Aug 1982
HELENA HEMOGLOBIN DETECT COLUMN SYS
K820573 · Helena Laboratories · Apr 1982