Cleared Traditional

K031539 - HEMOGLOBIN A1C REAGENT SET

K031539 is the FDA 510(k) clearance for HEMOGLOBIN A1C REAGENT SET by Pointe Scientific, Inc.,. It is a Class 2 Chemistry device (product code LCP) cleared through the Traditional 510(k) pathway after a 82-day FDA review.

K031539 · Pointe Scientific, Inc., · Chemistry device

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Aug 2003

Decision

82d

Days

Class 2

Risk

K031539 is an FDA 510(k) clearance for the HEMOGLOBIN A1C REAGENT SET. Classified as Assay, Glycosylated Hemoglobin (product code LCP), Class II - Special Controls.

Submitted by Pointe Scientific, Inc., (Lincoln Park, US). The FDA issued a Cleared decision on August 6, 2003 after a review of 82 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 864.7470 - the FDA in vitro diagnostics and chemistry 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 Pointe Scientific, Inc., devices

Submission Details

510(k) Number	K031539 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	May 16, 2003
Decision Date	August 06, 2003
Days to Decision	82 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Statement
Third-party Review	No - reviewed directly by FDA
Combination Product	No
PCCP Authorized	No

Regulatory Context

Review time vs. panel average

6d faster than avg

Panel avg: 88d · This submission: 82d

Pathway characteristics

Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code	LCP Assay, Glycosylated Hemoglobin
Device Class	Class 2 - Special Controls
CFR Regulation	21 CFR 864.7470

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 Chemistry devices follow this clearance model.

Regulatory Peers - LCP Assay, Glycosylated Hemoglobin

All 136

Devices cleared under the same product code (LCP) and FDA review panel - the closest regulatory comparables to K031539.

OLYMPUS HBA1C REAGENT, (CATALOG NUMBER OSR6192), OLYMPUS HBA1C CALIBRATOR, (CATOLOG NUMBER ODC3032)

K031380 · Olympus America, Inc. · Nov 2003

ATAC HEMOGLOBIN A1C REAGENT KIT

K031042 · Clinical Data, Inc. · Nov 2003

D-10 HEMOGLOBIN A1C

K031043 · Bio-Rad Laboratories, Inc. · Aug 2003

RANDOX FRUCTOSAMINE, FRUCTOSAMINE CALIBRATOR, FRUCTOSAMINE CONTROLS

K023763 · Randox Laboratories, Ltd. · Jan 2003

RANDOX HAEMOGLOBIN A1C

K021897 · Randox Laboratories, Ltd. · Nov 2002

DIMENSION HAIC ASSAY, MODEL DF105

K011852 · Dade Behring, Inc. · Nov 2001

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K031539

Pointe Scientific, Inc.,

Lincoln Park, MI · US

WILLIAM F WALTERS

Regulatory profile

74 submissions 74 cleared

100% clearance rate · Active in Chemistry

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