Cleared Traditional

K971640 - LEADCARE BLOOD LEAD TESTING SYSTEM

K971640 is an FDA 510(k) clearance for LEADCARE BLOOD LEAD TESTING SYSTEM, manufactured by Esa, Inc.. The device is a Class 2 Toxicology device with product code DOF cleared through the Traditional 510(k) pathway after a 130-day FDA review.

K971640 · Esa, Inc. · Toxicology device
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Sep 1997
Decision
130d
Days
Class 2
Risk

K971640 is an FDA 510(k) clearance for the LEADCARE BLOOD LEAD TESTING SYSTEM. Classified as Lead, Atomic Absorption (product code DOF), Class II - Special Controls.

Submitted by Esa, Inc. (Chelmsford, US). The FDA issued a Cleared decision on September 9, 1997 after a review of 130 days - within the typical 510(k) review window.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3550 - the FDA toxicology 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 Toxicology review framework, consistent with the majority of Class II 510(k) submissions.

View all Esa, Inc. devices

FDA 510(k) Submission Details - K971640

510(k) Number K971640 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 02, 1997
Decision Date September 09, 1997
Days to Decision 130 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
43d slower than avg
Panel avg: 87d · This submission: 130d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 Toxicology devices follow this clearance model.