Cleared Traditional

K781853 - CHOLESTEROL STANDARDS

K781853 is the FDA 510(k) clearance for CHOLESTEROL STANDARDS by Bd Becton Dickinson Vacutainer Systems Preanalytic. It is a Class 2 Chemistry device (product code JIS) cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K781853 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Chemistry device
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Dec 1978
Decision
28d
Days
Class 2
Risk

K781853 is an FDA 510(k) clearance for the CHOLESTEROL STANDARDS. Classified as Calibrator, Primary (product code JIS), Class II - Special Controls.

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Washington, US). The FDA issued a Cleared decision on December 4, 1978 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1150 - 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 Bd Becton Dickinson Vacutainer Systems Preanalytic devices

Submission Details

510(k) Number K781853 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 1978
Decision Date December 04, 1978
Days to Decision 28 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
60d faster than avg
Panel avg: 88d · This submission: 28d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JIS Calibrator, Primary
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1150
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.

Regulatory Peers - JIS Calibrator, Primary

All 96
Devices cleared under the same product code (JIS) and FDA review panel - the closest regulatory comparables to K781853.
LITHIUM STANDARD (1MM/L)
K800042 · Gilford Diagnostics · Jan 1980
URIC ACID STANDARD
K792046 · Gilford Diagnostics · Oct 1979
SPECTRO-SUR SET
K791315 · Helena Laboratories · Aug 1979
EMIT ANTIEPILEPTIC DRUG CALIBRATORS
K780467 · Syva Co. · Apr 1978
BIO TROL-T TRIOLEIN SOLUTIONS
K770072 · Boehringer Mannheim Corp. · Jan 1977
REFEREE AQUEOUS TRIGLYCERIDE STND
K760806 · Analytical Products, Inc. · Oct 1976