Cleared Traditional

K990247 - MTM BIOSCANNER HDL

K990247 is an FDA 510(k) clearance for MTM BIOSCANNER HDL, manufactured by Polymer Technology Systems, Inc.. The device is a Class 1 Chemistry device with product code LBR cleared through the Traditional 510(k) pathway after a 122-day FDA review.

K990247 · Polymer Technology Systems, Inc. · Chemistry device
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May 1999
Decision
122d
Days
Class 1
Risk

K990247 is an FDA 510(k) clearance for the MTM BIOSCANNER HDL, MODEL # BSA450, BSA460, BSA470. Classified as Ldl & Vldl Precipitation, Hdl (product code LBR), Class I - General Controls.

Submitted by Polymer Technology Systems, Inc. (Indianapolis, US). The FDA issued a Cleared decision on May 28, 1999 after a review of 122 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1475 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Polymer Technology Systems, Inc. devices

FDA 510(k) Submission Details - K990247

510(k) Number K990247 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 26, 1999
Decision Date May 28, 1999
Days to Decision 122 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
34d slower than avg
Panel avg: 88d · This submission: 122d
Pathway characteristics
Predicate-based equivalence.

LBR Device Classification - Class 1, General Controls

Product Code LBR Ldl & Vldl Precipitation, Hdl
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1475
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - LBR Ldl & Vldl Precipitation, Hdl

All 38
Devices cleared under the same product code (LBR) and FDA review panel - the closest regulatory comparables to K990247.
RAICHEM HDL CHOLESTEROL USING CANTROL HDL PRECIPITATING TUBES ON THE COBAS MIRA ANAYLZER
K023784 · Hemagen Diagnostics, Inc. · Dec 2002
VITROS CHEMISTRY PRODUCTS MAGNETIC HDL-CHOLESTEROL REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 2
K012593 · Ortho-Clinical Diagnostics, Inc. · Aug 2001
AUTOHDL CHOLESTEROL REAGENT SET
K992002 · Pointe Scientific, Inc., · Aug 1999
VITROS CHEMISTRY PRODUCTS MAGNETIC HDL-CHOLESTEROL REAGENT
K984303 · Ortho-Clinical Diagnostics, Inc. · Jan 1999
HDL-CHOLESTEROL PRECIPITATING REAGENT, CATALOGUE NUMBER 205-51
K980772 · Diagnostic Chemicals , Ltd. · Apr 1998
HDL UNI-PAKS (PTA), CATALOGUE NUMBER 215-51
K980770 · Diagnostic Chemicals , Ltd. · Apr 1998