Cleared Traditional

K011033 - DIMENSION LITHIUM (LI) FLEX REAGENT CAR...

K011033 is the FDA 510(k) clearance for DIMENSION LITHIUM (LI) FLEX REAGENT CAR... by Dade Behring, Inc.. It is a Class 2 Chemistry device (product code JIH) cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K011033 · Dade Behring, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2001
Decision
63d
Days
Class 2
Risk

K011033 is an FDA 510(k) clearance for the DIMENSION LITHIUM (LI) FLEX REAGENT CARTRIDGE, MODEL DF 132. Classified as Flame Photometry, Lithium (product code JIH), Class II - Special Controls.

Submitted by Dade Behring, Inc. (Newark, US). The FDA issued a Cleared decision on June 7, 2001 after a review of 63 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3560 - 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: 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 Dade Behring, Inc. devices

Submission Details

510(k) Number K011033 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 05, 2001
Decision Date June 07, 2001
Days to Decision 63 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 faster than avg
Panel avg: 88d · This submission: 63d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JIH Flame Photometry, Lithium
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3560
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - JIH Flame Photometry, Lithium

All 8
Devices cleared under the same product code (JIH) and FDA review panel - the closest regulatory comparables to K011033.
KODAK EKTACHEM DTSC II SLIDES (LI)
K934106 · Eastman Kodak Company · Apr 1994
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (LI)
K924488 · Eastman Kodak Company · Jan 1993
MODEL 654 ANALYZER
K921403 · Ciba Corning Diagnostics Corp. · Jul 1992
AMDEV LYTENING 2Z SODIUM/POTASSIUM/LITHIUM ANALYZE
K895465 · Baxter Healthcare Corp · Dec 1989
TDX(R) LITES(TM) LITHIUM
K894328 · Abbott Laboratories · Nov 1989
LITHIUM DILUENT (1500 MM/E)
K800039 · Gilford Diagnostics · Jan 1980