Cleared Traditional

K831871 - SICKLE-HEME A/S CONTROLS & A/A CONTROL (FDA 510(k) Clearance)

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

K831871 · Anco Medical Reagents & Assoc. · Chemistry device
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Jul 1983
Decision
45d
Days
Class 2
Risk

K831871 is an FDA 510(k) clearance for the SICKLE-HEME A/S CONTROLS & A/A CONTROL. Classified as Test, Sickle Cell (product code GHM), Class II - Special Controls.

Submitted by Anco Medical Reagents & Assoc. (Mchenry, US). The FDA issued a Cleared decision on July 28, 1983 after a review of 45 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 864.7825 - 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 Anco Medical Reagents & Assoc. devices

Submission Details

510(k) Number K831871 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 13, 1983
Decision Date July 28, 1983
Days to Decision 45 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
43d faster than avg
Panel avg: 88d · This submission: 45d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GHM Test, Sickle Cell
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7825
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.