Cleared Traditional

K801771 - ALPHA-THAL SCREEN 20 TEST KIT & 100 KIT

K801771 is the FDA 510(k) clearance for ALPHA-THAL SCREEN 20 TEST KIT & 100 KIT by Isolab, Inc.. It is a Class 2 Hematology device (product code LGL) cleared through the Traditional 510(k) pathway after a 172-day FDA review.

K801771 · Isolab, Inc. · Hematology device
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Jan 1981
Decision
172d
Days
Class 2
Risk

K801771 is an FDA 510(k) clearance for the ALPHA-THAL SCREEN 20 TEST KIT & 100 KIT. Classified as Assay, Bart's, Hemoglobin (product code LGL), Class II - Special Controls.

Submitted by Isolab, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 16, 1981 after a review of 172 days - an extended review cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7500 - 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.

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Submission Details

510(k) Number K801771 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 1980
Decision Date January 16, 1981
Days to Decision 172 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
59d slower than avg
Panel avg: 113d · This submission: 172d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LGL Assay, Bart's, Hemoglobin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7500
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.