Cleared Traditional

K053236 - DAVID PREGNANCY TEST (MIDSTREAM)

K053236 is an FDA 510(k) clearance for DAVID PREGNANCY TEST (MIDSTREAM), manufactured by Runbio Biotech Co.,Ltd. The device is a Class 2 Chemistry device with product code LCX cleared through the Traditional 510(k) pathway after a 242-day FDA review.

K053236 · Runbio Biotech Co.,Ltd · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2006
Decision
242d
Days
Class 2
Risk

K053236 is an FDA 510(k) clearance for the DAVID PREGNANCY TEST (MIDSTREAM). Classified as Kit, Test, Pregnancy, Hcg, Over The Counter (product code LCX), Class II - Special Controls.

Submitted by Runbio Biotech Co.,Ltd (Tacoma, US). The FDA issued a Cleared decision on July 18, 2006 after a review of 242 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1155 - 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 Runbio Biotech Co.,Ltd devices

FDA 510(k) Submission Details - K053236

510(k) Number K053236 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 18, 2005
Decision Date July 18, 2006
Days to Decision 242 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
154d slower than avg
Panel avg: 88d · This submission: 242d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LCX Device Classification - Class 2, Special Controls

Product Code LCX Kit, Test, Pregnancy, Hcg, Over The Counter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1155
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 - LCX Kit, Test, Pregnancy, Hcg, Over The Counter

All 167
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