Cleared Traditional

K001647 - BN PROSPEC SYSTEM

K001647 is an FDA 510(k) clearance for BN PROSPEC SYSTEM, manufactured by Dade Behring, Inc.. The device is a Class 1 Immunology device with 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

FDA 510(k) Submission Details - K001647

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
14d slower than avg
Panel avg: 105d · This submission: 119d
Pathway characteristics
Predicate-based equivalence.

JZW Device Classification - Class 1, General Controls

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