Cleared Traditional

K982708 - SPQ TEST SYSTEM

K982708 is an FDA 510(k) clearance for SPQ TEST SYSTEM, manufactured by DiaSorin, Inc.. The device is a Class 2 Chemistry device with product code DFC cleared through the Traditional 510(k) pathway after a 241-day FDA review.

K982708 · DiaSorin, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1999
Decision
241d
Days
Class 2
Risk

K982708 is an FDA 510(k) clearance for the SPQ TEST SYSTEM. Classified as Lipoprotein, Low-density, Antigen, Antiserum, Control (product code DFC), Class II - Special Controls.

Submitted by DiaSorin, Inc. (Columbia, US). The FDA issued a Cleared decision on April 2, 1999 after a review of 241 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 866.5600 - 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 DiaSorin, Inc. devices

FDA 510(k) Submission Details - K982708

510(k) Number K982708 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 1998
Decision Date April 02, 1999
Days to Decision 241 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
153d slower than avg
Panel avg: 88d · This submission: 241d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DFC Device Classification - Class 2, Special Controls

Product Code DFC Lipoprotein, Low-density, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5600
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 - DFC Lipoprotein, Low-density, Antigen, Antiserum, Control

All 37
Devices cleared under the same product code (DFC) and FDA review panel - the closest regulatory comparables to K982708.
MACRA LP(A) ENZYME IMMUNOASSAY KIT
K992665 · Trinity Biotech USA · Nov 1999
LIPOPROTEIN (A) SPQ III ANTIBODY REAGENT SET
K993669 · DiaSorin, Inc. · Nov 1999
INTEGRA REAGENT CASSETTE FOR APOLIPOPROTEIN B
K990595 · Roche Diagnostics Corp. · Apr 1999
WAKO AUTOKIT LP(A)
K981446 · Wako Chemicals USA, Inc. · Mar 1999
APOB
K983281 · Abbott Laboratories · Jan 1999
IMX HOMOCYSTEINE
K980812 · Axis Biochemicals, Asa · Oct 1998