Cleared Traditional

K161679 - s LDL-EX SEIKEN (FDA 510(k) Clearance)

Class I Chemistry device.

K161679 · Denka Seiken Co., Ltd. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2017
Decision
427d
Days
Class 1
Risk

K161679 is an FDA 510(k) clearance for the s LDL-EX SEIKEN. Classified as Low-density Lipoprotein (ldl) Cholesterol Sub-fraction Test (product code PYP), Class I - General Controls.

Submitted by Denka Seiken Co., Ltd. (Gosen, JP). The FDA issued a Cleared decision on August 18, 2017 after a review of 427 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Chemistry submissions.

View all Denka Seiken Co., Ltd. devices

Submission Details

510(k) Number K161679 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 2016
Decision Date August 18, 2017
Days to Decision 427 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
339d slower than avg
Panel avg: 88d · This submission: 427d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code PYP Low-density Lipoprotein (ldl) Cholesterol Sub-fraction Test
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1475
Definition For The Quantitative Determination Of Low-density Lipoprotein (ldl) Cholesterol Sub-fractions.
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.