Cleared Traditional

K042379 - ANEMIAPRO SELF-SCREENER

K042379 is an FDA 510(k) clearance for ANEMIAPRO SELF-SCREENER, manufactured by Biosafe Laboratories, Inc.. The device is a Class 2 Hematology device with product code KHG cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K042379 · Biosafe Laboratories, Inc. · Hematology device
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Dec 2004
Decision
105d
Days
Class 2
Risk

K042379 is an FDA 510(k) clearance for the ANEMIAPRO SELF-SCREENER. Classified as Whole Blood Hemoglobin Determination (product code KHG), Class II - Special Controls.

Submitted by Biosafe Laboratories, Inc. (Lake Forest, US). The FDA issued a Cleared decision on December 15, 2004 after a review of 105 days - within the typical 510(k) review window.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7500 - the FDA hematology 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 Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all Biosafe Laboratories, Inc. devices

FDA 510(k) Submission Details - K042379

510(k) Number K042379 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 01, 2004
Decision Date December 15, 2004
Days to Decision 105 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
8d faster than avg
Panel avg: 113d · This submission: 105d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KHG Device Classification - Class 2, Special Controls

Product Code KHG Whole Blood Hemoglobin Determination
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7500
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 Hematology devices follow this clearance model.

Regulatory Peers - KHG Whole Blood Hemoglobin Determination

All 30
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