Cleared Traditional

K871290 - CENTRICELL(TM)

K871290 is an FDA 510(k) clearance for CENTRICELL(TM), manufactured by Polysciences, Inc.. The device is a Class 1 Chemistry device with product code JJH cleared through the Traditional 510(k) pathway after a 127-day FDA review.

K871290 · Polysciences, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1987
Decision
127d
Days
Class 1
Risk

K871290 is an FDA 510(k) clearance for the CENTRICELL(TM). Classified as Clinical Sample Concentrator (product code JJH), Class I - General Controls.

Submitted by Polysciences, Inc. (Warrington, US). The FDA issued a Cleared decision on August 5, 1987 after a review of 127 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2310 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Polysciences, Inc. devices

FDA 510(k) Submission Details - K871290

510(k) Number K871290 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 1987
Decision Date August 05, 1987
Days to Decision 127 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
39d slower than avg
Panel avg: 88d · This submission: 127d
Pathway characteristics
Predicate-based equivalence.

JJH Device Classification - Class 1, General Controls

Product Code JJH Clinical Sample Concentrator
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2310
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 - JJH Clinical Sample Concentrator

All 10
Devices cleared under the same product code (JJH) and FDA review panel - the closest regulatory comparables to K871290.
ULTRAFREE-CL
K941326 · Millipore Corp. · May 1994
CENTRICON -50 CONCENTRATOR
K930168 · Amicon, Inc. · Aug 1993
CENTRICON CONCENTRATOR
K893733 · Amicon, Inc. · Jul 1989
CENTRIPREP CONCENTRATOR
K870690 · Amicon, Inc. · Mar 1987
DUPONT PREP FOUR-SOLVENT RETROFIT KIT
K851393 · E.I. Dupont DE Nemours & Co., Inc. · Jul 1985
CENTRICON MICRO-CONCENTRATOR
K833919 · Amicon, Inc. · Jan 1984