Cleared Traditional

ALPHA-THAL SCREEN TM CONTROL (K810976) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K810976 · Isolab, Inc. · Chemistry device
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May 1981
Decision
49d
Days
Class 2
Risk

K810976 is an FDA 510(k) clearance for the ALPHA-THAL SCREEN TM CONTROL. 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 May 29, 1981 after a review of 49 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 864.7500 - the FDA in vitro diagnostics and chemistry 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 K810976 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 1981
Decision Date May 29, 1981
Days to Decision 49 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 88d · This submission: 49d
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 Chemistry devices follow this clearance model.