Cleared Traditional

HISTOPAQUE-1077 (K842146) - FDA 510(k) Clearance

Class I Hematology device.

K842146 · Sigma Chemical Co. · Hematology device
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Jul 1984
Decision
58d
Days
Class 1
Risk

K842146 is an FDA 510(k) clearance for the HISTOPAQUE-1077. Classified as Lymphocyte Separation Medium (product code JCF), Class I - General Controls.

Submitted by Sigma Chemical Co. (Walker, US). The FDA issued a Cleared decision on July 27, 1984 after a review of 58 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.8500 - 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 K842146 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 30, 1984
Decision Date July 27, 1984
Days to Decision 58 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
55d faster than avg
Panel avg: 113d · This submission: 58d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JCF Lymphocyte Separation Medium
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 864.8500
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - JCF Lymphocyte Separation Medium

All 11
Devices cleared under the same product code (JCF) and FDA review panel - the closest regulatory comparables to K842146.
LEUCOPREP(R) BRAND CELL SEPARAT TUBE W/SODIUM CITR
K911731 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Dec 1992
LEUCOPREP CELL SEPARATION TUBE
K891407 · Bd Becton Dickinson Vacutainer Systems Preanalytic · May 1989
L-PHENYLALANINE METHYL ESTER HYDROCHLORIDE PME REA
K874328 · E.I. Dupont DE Nemours & Co., Inc. · Feb 1988
LEUCOPREP BRAND TUBE
K872775 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 1987
LEUCO PREP
K854093 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Nov 1985
CST
K842818 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 1984