Cleared Traditional

K070552 - DIMENSION VISTA FERRITIN FLEX REAGENT CARTRIDGE (FERR)

K070552 is an FDA 510(k) clearance for DIMENSION VISTA FERRITIN FLEX REAGENT C..., manufactured by Dade Behring, Inc.. The device is a Class 2 Immunology device with product code JIT cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K070552 · Dade Behring, Inc. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2007
Decision
62d
Days
Class 2
Risk

K070552 is an FDA 510(k) clearance for the DIMENSION VISTA FERRITIN FLEX REAGENT CARTRIDGE (FERR). Classified as Calibrator, Secondary (product code JIT), Class II - Special Controls.

Submitted by Dade Behring, Inc. (Newark, US). The FDA issued a Cleared decision on April 30, 2007 after a review of 62 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 862.1150 - 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: 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

FDA 510(k) Submission Details - K070552

510(k) Number K070552 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 2007
Decision Date April 30, 2007
Days to Decision 62 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
43d faster than avg
Panel avg: 105d · This submission: 62d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JIT Device Classification - Class 2, Special Controls

Product Code JIT Calibrator, Secondary
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1150
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 Immunology devices follow this clearance model.

Regulatory Peers - JIT Calibrator, Secondary

All 208
Devices cleared under the same product code (JIT) and FDA review panel - the closest regulatory comparables to K070552.
ACCESS ESTRADIOL CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 33545
K080166 · Beckman Coulter, Inc. · Mar 2008
DIMENSION VISTA SYSTEM BILIRUBIN CALIBRATOR, MODEL KC210
K072717 · Dade Behring, Inc. · Dec 2007
MISSION OLYMPUS AU ISE CALIBRATORS
K071039 · Diamond Diagnostics, Inc. · Aug 2007
INHIBIN A CALIBRATORS & CONTROLS ON THE ACCESS IMMUNOASSAY SYSTEMS
K070144 · Beckman Coulter, Inc. · Feb 2007
ABX PENTRA 400: LIPOPROTEINS
K060854 · Horiba Abx · Aug 2006
CREATININE KINASE MB ISOENZYME VERIFIER, MODEL DC27
K062152 · Dade Behring, Inc. · Aug 2006