Cleared Traditional

DS30 HCY HOMOCYSTEINE ASSAY KIT (K982003) - FDA 510(k) Clearance

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

K982003 · Drew Scientific , Ltd. · Hematology device
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Feb 1999
Decision
248d
Days
Class 2
Risk

K982003 is an FDA 510(k) clearance for the DS30 HCY HOMOCYSTEINE ASSAY KIT. Classified as Urinary Homocystine (nonquantitative) Test System (product code LPS), Class II - Special Controls.

Submitted by Drew Scientific , Ltd. (Barrow In Furness, GB). The FDA issued a Cleared decision on February 11, 1999 after a review of 248 days - an extended review cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 862.1377 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all Drew Scientific , Ltd. devices

Submission Details

510(k) Number K982003 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 1998
Decision Date February 11, 1999
Days to Decision 248 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
135d slower than avg
Panel avg: 113d · This submission: 248d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LPS Urinary Homocystine (nonquantitative) Test System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1377
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 - LPS Urinary Homocystine (nonquantitative) Test System

All 28
Devices cleared under the same product code (LPS) and FDA review panel - the closest regulatory comparables to K982003.
DIMENSION VISTA HCYS FLEX REAGENT CARTRIDGE
K063206 · Dade Behring, Inc. · Dec 2006
HEMOSIL HOMOCYSTEINE AND CONTROLS
K061598 · Instrumentation Laboratory CO · Sep 2006
N LATEX HCY, N PROTEIN STANDARD SL, N/T PROTEIN CONTROL L/M/H
K052788 · Dade Behring, Inc. · Mar 2006
IMMULITE HOMOCYSTEINE MODEL LKHO1 / IMMULITE 2000 HOMOCYSTEINE MODEL L2KHO2
K003597 · Diagnostic Products Corp. · Feb 2001
BIO-RAD HOMOCYSTEINE BY HPLC
K993107 · Bio-Rad · Dec 1999
ABBOTT AXSYM HOMOCYSTEINE
K992858 · Abbott Laboratories · Oct 1999