Cleared Traditional

K073072 - DIMENSION AHDL FLEX REAGENT CARTRIDGE, MODEL: DF48B

K073072 is an FDA 510(k) clearance for DIMENSION AHDL FLEX REAGENT CARTRIDGE, manufactured by Dade Behring, Inc.. The device is a Class 1 Chemistry device with product code JHM cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K073072 · Dade Behring, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2008
Decision
113d
Days
Class 1
Risk

K073072 is an FDA 510(k) clearance for the DIMENSION AHDL FLEX REAGENT CARTRIDGE, MODEL: DF48B. Classified as Colorimetric Method, Lipoproteins (product code JHM), Class I - General Controls.

Submitted by Dade Behring, Inc. (P.O. Box 6101, Newark, US). The FDA issued a Cleared decision on February 21, 2008 after a review of 113 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1475 - 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 Dade Behring, Inc. devices

FDA 510(k) Submission Details - K073072

510(k) Number K073072 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 31, 2007
Decision Date February 21, 2008
Days to Decision 113 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
25d slower than avg
Panel avg: 88d · This submission: 113d
Pathway characteristics
Predicate-based equivalence.

JHM Device Classification - Class 1, General Controls

Product Code JHM Colorimetric Method, Lipoproteins
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1475
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 - JHM Colorimetric Method, Lipoproteins

All 7
Devices cleared under the same product code (JHM) and FDA review panel - the closest regulatory comparables to K073072.
PICCOLO HDL-CAPILLARY TEST SYSTEM
K120662 · Abaxis, Inc. · Apr 2012
DIMENSION VISTA HDLC FLEX REAGENT CARTRIDGE
K081300 · Siemens Healthcare Diagnostics · Jul 2008
DIMENSION AUTOMATED HDL CHOLESTEROL (AHDL) FLEX REAGENT CARTRIDGE (DF48A) CATALOG # DF48A
K032798 · Dade Behring, Inc. · Oct 2003
LDL CHOLESTEROL (AUTOMATED)
K022519 · Jas Diagnostics, Inc. · Sep 2002
DIMENSION AUTOMATED HIGH DENSITY LIPOPROTEIN CHOLESTEROL (ADHL) FLEX REAGENT CARTRIDGE
K983849 · Dade Behring, Inc. · Jan 1999
ROCHE COBAS READY HDL CHOLESTEROL REAGENT
K902935 · Roche Diagnostic Systems, Inc. · Sep 1990