Cleared Traditional

K811927 - 1F BLOCKING ANTIBODY(57 CO) RADIOASSAY (FDA 510(k) Clearance)

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

K811927 · Corning Medical & Scientific · Hematology device
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Apr 1982
Decision
269d
Days
Class 2
Risk

K811927 is an FDA 510(k) clearance for the 1F BLOCKING ANTIBODY(57 CO) RADIOASSAY. Classified as Radioassay, Intrinsic Factor Blocking Antibody (product code LIG), Class II - Special Controls.

Submitted by Corning Medical & Scientific (Mchenry, US). The FDA issued a Cleared decision on April 1, 1982 after a review of 269 days - an extended review cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 862.1810 - 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 K811927 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 1981
Decision Date April 01, 1982
Days to Decision 269 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
156d slower than avg
Panel avg: 113d · This submission: 269d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LIG Radioassay, Intrinsic Factor Blocking Antibody
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1810
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.