Cleared Traditional

K780573 - TECHNIQUE, CHROMATOGRAPHIC, HEMOGLOBIN (FDA 510(k) Clearance)

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

K780573 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Hematology device
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Nov 1978
Decision
211d
Days
Class 2
Risk

K780573 is an FDA 510(k) clearance for the TECHNIQUE, CHROMATOGRAPHIC, HEMOGLOBIN. Classified as Assay, Glycosylated Hemoglobin (product code LCP), Class II - Special Controls.

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Washington, US). The FDA issued a Cleared decision on November 7, 1978 after a review of 211 days - an extended review cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7470 - 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.

View all Bd Becton Dickinson Vacutainer Systems Preanalytic devices

Submission Details

510(k) Number K780573 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 1978
Decision Date November 07, 1978
Days to Decision 211 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
98d slower than avg
Panel avg: 113d · This submission: 211d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LCP Assay, Glycosylated Hemoglobin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7470
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.