Cleared Traditional

CALTAG FETAL HEMOGLOBIN TEST (K990641) - FDA 510(k) Clearance

Class II Hematology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K990641 · Caltag Laboratories, Inc. · Hematology device
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Sep 1999
Decision
203d
Days
Class 2
Risk

K990641 is an FDA 510(k) clearance for the CALTAG FETAL HEMOGLOBIN TEST. Classified as Stain, Fetal Hemoglobin (product code GHQ), Class II - Special Controls.

Submitted by Caltag Laboratories, Inc. (Dowingtown, US). The FDA issued a Cleared decision on September 17, 1999 after a review of 203 days - an extended review cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7455 - 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 Caltag Laboratories, Inc. devices

Submission Details

510(k) Number K990641 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 1999
Decision Date September 17, 1999
Days to Decision 203 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
90d slower than avg
Panel avg: 113d · This submission: 203d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GHQ Stain, Fetal Hemoglobin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7455
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.