Cleared Traditional

K780097 - QUALITY CONTROL SYSTEM, SPECTRA

K780097 is an FDA 510(k) clearance for QUALITY CONTROL SYSTEM, manufactured by Bd Becton Dickinson Vacutainer Systems Preanalytic. The device is a Class 2 Hematology device with product code KSF cleared through the Traditional 510(k) pathway after a 95-day FDA review.

K780097 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Hematology device
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Apr 1978
Decision
95d
Days
Class 2
Risk

K780097 is an FDA 510(k) clearance for the QUALITY CONTROL SYSTEM, SPECTRA. Classified as Kit, Quality Control For Blood Banking Reagents (product code KSF), Class II - Special Controls.

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Washington, US). The FDA issued a Cleared decision on April 24, 1978 after a review of 95 days - within the typical 510(k) review window.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.9650 - 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

FDA 510(k) Submission Details - K780097

510(k) Number K780097 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 19, 1978
Decision Date April 24, 1978
Days to Decision 95 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
18d faster than avg
Panel avg: 113d · This submission: 95d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KSF Device Classification - Class 2, Special Controls

Product Code KSF Kit, Quality Control For Blood Banking Reagents
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.9650
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.

Regulatory Peers - KSF Kit, Quality Control For Blood Banking Reagents

All 8
Devices cleared under the same product code (KSF) and FDA review panel - the closest regulatory comparables to K780097.
ORTHO ANTISERA CONTROL
K800310 · Ortho Diagnostics, Inc. · Mar 1980
TEST CELLS
K790249 · Hyland Therapeutic Div., Travenol Laboratories · May 1979
COUNTER CHECK, H001, H002, H003
K790025 · Diagnostic Technology, Inc. · Jan 1979
REAGENT CONFIDENCE SERA
K771814 · Ortho Diagnostics, Inc. · Nov 1977
UNIVAL CONTROL CELLS
K761284 · Dade, Baxter Travenol Diagnostics, Inc. · Jan 1977