Cleared Traditional

K820630 - QUIK-SEP HEMOGLOBIN F ASSAY & CONTROL

K820630 is an FDA 510(k) clearance for QUIK-SEP HEMOGLOBIN F ASSAY & CONTROL, manufactured by Isolab, Inc.. The device is a Class 2 Hematology device with product code JPC cleared through the Traditional 510(k) pathway after a 109-day FDA review.

K820630 · Isolab, Inc. · Hematology device
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Jun 1982
Decision
109d
Days
Class 2
Risk

K820630 is an FDA 510(k) clearance for the QUIK-SEP HEMOGLOBIN F ASSAY & CONTROL. Classified as Hemoglobin F Quantitation (product code JPC), Class II - Special Controls.

Submitted by Isolab, Inc. (Walker, US). The FDA issued a Cleared decision on June 25, 1982 after a review of 109 days - within the typical 510(k) review window.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7455 - 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 Isolab, Inc. devices

FDA 510(k) Submission Details - K820630

510(k) Number K820630 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 1982
Decision Date June 25, 1982
Days to Decision 109 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
4d faster than avg
Panel avg: 113d · This submission: 109d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JPC Device Classification - Class 2, Special Controls

Product Code JPC Hemoglobin F Quantitation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7455
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.