Cleared Traditional

K840011 - RESOLVE-HB

K840011 is the FDA 510(k) clearance for RESOLVE-HB by Isolab, Inc.. It is a Class 2 Hematology device (product code GKA) cleared through the Traditional 510(k) pathway after a 31-day FDA review.

K840011 · Isolab, Inc. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1984
Decision
31d
Days
Class 2
Risk

K840011 is an FDA 510(k) clearance for the RESOLVE-HB. Classified as Abnormal Hemoglobin Quantitation (product code GKA), Class II - Special Controls.

Submitted by Isolab, Inc. (Walker, US). The FDA issued a Cleared decision on February 4, 1984 after a review of 31 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Isolab, Inc. devices

Submission Details

510(k) Number K840011 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 04, 1984
Decision Date February 04, 1984
Days to Decision 31 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
82d faster than avg
Panel avg: 113d · This submission: 31d
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 13
Devices cleared under the same product code (GKA) and FDA review panel - the closest regulatory comparables to K840011.
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
ISOPROPANOL HEMOGLOBIN STABILITY TEST
K822123 · Helena Laboratories · Aug 1982
HELENA HEMOGLOBIN DETECT COLUMN SYS
K820573 · Helena Laboratories · Apr 1982
ORTHO SICKLE CELL CONTROLS
K811894 · Ortho Diagnostic Systems, Inc. · Jul 1981