Cleared Traditional

K932872 - SICKLE CELL TEST KIT

K932872 is an FDA 510(k) clearance for SICKLE CELL TEST KIT, manufactured by Histo-Med, Inc.. The device is a Class 2 Hematology device with product code JBB cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K932872 · Histo-Med, Inc. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1993
Decision
63d
Days
Class 2
Risk

K932872 is an FDA 510(k) clearance for the SICKLE CELL TEST KIT. Classified as Solubility, Hemoglobin, Abnormal (product code JBB), Class II - Special Controls.

Submitted by Histo-Med, Inc. (Orange City, US). The FDA issued a Cleared decision on August 16, 1993 after a review of 63 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7825 - 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: 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 Histo-Med, Inc. devices

FDA 510(k) Submission Details - K932872

510(k) Number K932872 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 1993
Decision Date August 16, 1993
Days to Decision 63 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 113d · This submission: 63d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JBB Device Classification - Class 2, Special Controls

Product Code JBB Solubility, Hemoglobin, Abnormal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7825
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.