Cleared Traditional

K843438 - FACTOR XI DEFICIENT PLASMA B11D (FDA 510(k) Clearance)

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

K843438 · Sigma Chemical Co. · Hematology device
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Nov 1984
Decision
76d
Days
Class 2
Risk

K843438 is an FDA 510(k) clearance for the FACTOR XI DEFICIENT PLASMA B11D. Classified as Test, Qualitative And Quantitative Factor Deficiency (product code GGP), Class II - Special Controls.

Submitted by Sigma Chemical Co. (St. Louis, US). The FDA issued a Cleared decision on November 19, 1984 after a review of 76 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7290 - 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 Sigma Chemical Co. devices

Submission Details

510(k) Number K843438 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 04, 1984
Decision Date November 19, 1984
Days to Decision 76 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 113d · This submission: 76d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GGP Test, Qualitative And Quantitative Factor Deficiency
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7290
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.

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