Cleared Traditional

K993590 - FRUCTOSAMINE REAGENT SET, CALIBRATOR, AND CONTROL SET

K993590 is an FDA 510(k) clearance for FRUCTOSAMINE REAGENT SET, manufactured by Pointe Scientific, Inc.,. The device is a Class 2 Chemistry device with product code LCP cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K993590 · Pointe Scientific, Inc., · Chemistry device
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Dec 1999
Decision
60d
Days
Class 2
Risk

K993590 is an FDA 510(k) clearance for the FRUCTOSAMINE REAGENT SET, CALIBRATOR, AND CONTROL 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 December 21, 1999 after a review of 60 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

FDA 510(k) Submission Details - K993590

510(k) Number K993590 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 22, 1999
Decision Date December 21, 1999
Days to Decision 60 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
28d faster than avg
Panel avg: 88d · This submission: 60d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LCP Device Classification - Class 2, Special Controls

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 202
Devices cleared under the same product code (LCP) and FDA review panel - the closest regulatory comparables to K993590.
NYCOCARD HBA1C GLYCOSYLATED HEMOGLOBIN ASSAY
K993131 · Primus, Inc. · May 2000
GLYPRO REAGENT, GLYPRO CALIBRATOR, GLYPRO LOW CONTROL, GLYPRO HIGH CONTROL
K000239 · Genzyme Corp. · Mar 2000
HEMOCHEK-A1C SAMPLE COLLECTION KIT
K990899 · Osborn Group, Inc. · Dec 1999
PRIMUS LIQUID CALIBRATOR FOR GHB/A1C LEVEL 1 AND LEVEL 2
K994045 · Primus Corp. · Dec 1999
FRUCTOSAMINE, MODEL FR 106-01
K991246 · A.P. Total Care, Inc. · Dec 1999
SAFE AT-HOME TEST KIT FOR MONITORING HEMOGLOBIN ALC
K991850 · Biosafe Laboratories, Inc. · Nov 1999