Cleared Traditional

K822044 - SERALYZER HEMOGLOBIN REAGENT STRIPS (FDA 510(k) Clearance)

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

K822044 · Miles Laboratories, Inc. · Hematology device
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Jul 1982
Decision
18d
Days
Class 2
Risk

K822044 is an FDA 510(k) clearance for the SERALYZER HEMOGLOBIN REAGENT STRIPS. Classified as Whole Blood Hemoglobin Determination (product code KHG), Class II - Special Controls.

Submitted by Miles Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 30, 1982 after a review of 18 days - a notably fast clearance cycle.

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: 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 Miles Laboratories, Inc. devices

Submission Details

510(k) Number K822044 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 12, 1982
Decision Date July 30, 1982
Days to Decision 18 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 113d · This submission: 18d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.