Cleared Special

K052549 - LEADCARE II BLOOD LEAD TESTING SYSTEM

K052549 is an FDA 510(k) clearance for LEADCARE II BLOOD LEAD TESTING SYSTEM, manufactured by Esa Biosciences, Inc.. The device is a Class 2 Chemistry device with product code DOF cleared through the Special 510(k) pathway after a 20-day FDA review.

K052549 · Esa Biosciences, Inc. · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2005
Decision
20d
Days
Class 2
Risk

K052549 is an FDA 510(k) clearance for the LEADCARE II BLOOD LEAD TESTING SYSTEM. Classified as Lead, Atomic Absorption (product code DOF), Class II - Special Controls.

Submitted by Esa Biosciences, Inc. (Chelmsford, US). The FDA issued a Cleared decision on October 6, 2005 after a review of 20 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3550 - the FDA in vitro diagnostics and chemistry framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K052549

510(k) Number K052549 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 2005
Decision Date October 06, 2005
Days to Decision 20 days
Submission Type Special
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
68d faster than avg
Panel avg: 88d · This submission: 20d
Pathway characteristics
Modification to existing cleared device.

DOF Device Classification - Class 2, Special Controls

Product Code DOF Lead, Atomic Absorption
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3550
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 - DOF Lead, Atomic Absorption

Devices cleared under the same product code (DOF) and FDA review panel - the closest regulatory comparables to K052549.
LeadCare Plus Blood Lead Testing System
K142705 · Magellan Diagnostics · Jul 2015
LEADCARE (R) ULTRA (TM) BLOOD LEAD TESTING SYSTEM
K123563 · Magellan Diagnostics · Aug 2013
LEADCARE BLOOD LEAD TESTING SYSTEM
K971640 · Esa, Inc. · Sep 1997
ATOMSPEC GF BLOOD LEAD WORKSTATION
K936060 · Thermo Jarrell Ash Corp.Div.Thermo Inst. · Sep 1994
K052549 · LEADCARE II BLOOD LEAD TESTING SYSTEM
Download PDF FDA Summary Esa Biosciences, Inc.