Cleared Traditional

SUDS(HCG)CONTROL SET (URINE&SERUM) & HCG REF.SERUM (K862048) - FDA 510(k) Clearance

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

K862048 · Murex Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1986
Decision
21d
Days
Class 2
Risk

K862048 is an FDA 510(k) clearance for the SUDS(HCG)CONTROL SET (URINE&SERUM) & HCG REF.SERUM. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Murex Corp. (Norcross, US). The FDA issued a Cleared decision on June 19, 1986 after a review of 21 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 870.1330 - 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 Murex Corp. devices

Submission Details

510(k) Number K862048 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 29, 1986
Decision Date June 19, 1986
Days to Decision 21 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
67d faster than avg
Panel avg: 88d · This submission: 21d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DQX Wire, Guide, Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1330
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 - DQX Wire, Guide, Catheter

All 763
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K862048.
InQwire Amplatz Guide Wire
K254137 · Merit Medical Ireland, Ltd. · May 2026
FMD Peripheral Guide Wire F-14 Flex 6
K260544 · FMD Co., Ltd. · Mar 2026
Enroute 0.014'' Transcarotid Guidewire
K253746 · Lake Region Medical · Mar 2026
EmeryGlide™ (EG18008901)
K253262 · Nano4imaging GmbH · Mar 2026
Splashwire Hydrophilic Guide Wire (MSWSTD35150J3)
K253847 · Merit Medical Ireland, Ltd. · Jan 2026
InQwire Super Stiff Guide Wire (IQSS32180J3)
K251385 · Merit Medical Ireland, Ltd. · Jan 2026