Cleared Traditional

K803248 - AMES SERA-PAK HEMOGLOBIN REAGENT

K803248 is the FDA 510(k) clearance for AMES SERA-PAK HEMOGLOBIN REAGENT by Miles Laboratories, Inc.. It is a Class 2 Hematology device (product code KHG) cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K803248 · Miles Laboratories, Inc. · Hematology device
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Jan 1981
Decision
34d
Days
Class 2
Risk

K803248 is an FDA 510(k) clearance for the AMES SERA-PAK HEMOGLOBIN REAGENT. 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 January 26, 1981 after a review of 34 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 K803248 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 1980
Decision Date January 26, 1981
Days to Decision 34 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
79d faster than avg
Panel avg: 113d · This submission: 34d
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.

Regulatory Peers - KHG Whole Blood Hemoglobin Determination

All 20
Devices cleared under the same product code (KHG) and FDA review panel - the closest regulatory comparables to K803248.
SERALYZER HEMOGLOBIN REAGENT STRIPS
K822044 · Miles Laboratories, Inc. · Jul 1982
SERALYZER HEMOGLOBIN TEST MODULE
K822045 · Miles Laboratories, Inc. · Jul 1982
CYANMETHEMOGLOBIN TEST
K820596 · Boehringer Mannheim Corp. · Mar 1982
CRC(CYANMETHEMOGLOBIN REAGENT CONCENT
K802268 · R&D Systems, Inc. · Dec 1980
COMPUR M-1000 MINI-PHOTOMETER
K800059 · Miles Laboratories, Inc. · Apr 1980
OXIMETER, CO-, IL MODEL 282
K760208 · Instrumentation Laboratory CO · Jul 1976