Cleared Traditional

K001647 - BN PROSPEC SYSTEM

K001647 is the FDA 510(k) clearance for BN PROSPEC SYSTEM by Dade Behring, Inc.. It is a Class 1 Immunology device (product code JZW) cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K001647 · Dade Behring, Inc. · Immunology device
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Sep 2000
Decision
119d
Days
Class 1
Risk

K001647 is an FDA 510(k) clearance for the BN PROSPEC SYSTEM. Classified as Nephelometer (product code JZW), Class I - General Controls.

Submitted by Dade Behring, Inc. (P.O. Box 6101, Newark, US). The FDA issued a Cleared decision on September 26, 2000 after a review of 119 days - within the typical 510(k) review window.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.4540 - the FDA immunology 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 Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Dade Behring, Inc. devices

Submission Details

510(k) Number K001647 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 30, 2000
Decision Date September 26, 2000
Days to Decision 119 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
15d slower than avg
Panel avg: 104d · This submission: 119d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JZW Nephelometer
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.4540
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 - JZW Nephelometer

All 9
Devices cleared under the same product code (JZW) and FDA review panel - the closest regulatory comparables to K001647.
BEHRING LASER NEPHELOMETER
K761234 · Behring Diagnostics, Inc. · Jun 1990
BEHRING NEPHELOMETER 100
K892223 · Behring Diagnostics, Inc. · May 1989
TURBOX
K873401 · Unipath , Ltd. · Sep 1987
RRT SYSTEM LASER REFLECTOMETER ANALYZER
K873407 · Incstar Corp. · Sep 1987
DISC 120 TRANSPORTER
K801391 · Travenol Laboratories, S.A. · Jul 1980
LANCER L-INA BUFFER, POLYMER, WASH SOLU
K792014 · Sherwood Medical Industries · Nov 1979