Cleared Traditional

K980770 - HDL UNI-PAKS (PTA)

K980770 is the FDA 510(k) clearance for HDL UNI-PAKS (PTA) by Diagnostic Chemicals , Ltd.. It is a Class 1 Chemistry device (product code LBR) cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K980770 · Diagnostic Chemicals , Ltd. · Chemistry device
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Apr 1998
Decision
60d
Days
Class 1
Risk

K980770 is an FDA 510(k) clearance for the HDL UNI-PAKS (PTA), CATALOGUE NUMBER 215-51. Classified as Ldl & Vldl Precipitation, Hdl (product code LBR), Class I - General Controls.

Submitted by Diagnostic Chemicals , Ltd. (Charlottetown, P.E.I., CA). The FDA issued a Cleared decision on April 21, 1998 after a review of 60 days - a notably fast clearance cycle.

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: 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 Diagnostic Chemicals , Ltd. devices

Submission Details

510(k) Number K980770 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 20, 1998
Decision Date April 21, 1998
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.

Device Classification

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 33
Devices cleared under the same product code (LBR) and FDA review panel - the closest regulatory comparables to K980770.
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
BOEHRINGER MANNHEIM DIRECT LDL - CHOLESTEROL
K974733 · Boehringer Mannheim Corp. · Jan 1998
ROCHE UNIMATE HDL DIRECT REAGEN (WITH POL CLAIM)
K973369 · Roche Diagnostic Systems, Inc. · Nov 1997
HDL-CHOLESTRAL(DEXTRAN SULFATE/MAGNESIUM)
K932766 · Diagnostic Chemicals, Ltd. (Usa) · Dec 1993