Cleared Traditional

K801410 - HEMOHLOBIN A2 CONTROL-LYOPHILIZED

K801410 is the FDA 510(k) clearance for HEMOHLOBIN A2 CONTROL-LYOPHILIZED by Isolab, Inc.. It is a Class 2 Hematology device (product code JPD) cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K801410 · Isolab, Inc. · Hematology device
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Jul 1980
Decision
35d
Days
Class 2
Risk

K801410 is an FDA 510(k) clearance for the HEMOHLOBIN A2 CONTROL-LYOPHILIZED. Classified as Hemoglobin A2 Quantitation (product code JPD), Class II - Special Controls.

Submitted by Isolab, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 21, 1980 after a review of 35 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7400 - 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 K801410 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 1980
Decision Date July 21, 1980
Days to Decision 35 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
78d faster than avg
Panel avg: 113d · This submission: 35d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JPD Hemoglobin A2 Quantitation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7400
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.