Cleared Traditional

K060677 - N LATEX CDT

K060677 is an FDA 510(k) clearance for N LATEX CDT, manufactured by Dade Behring, Inc.. The device is a Class 1 Chemistry device with product code NAO cleared through the Traditional 510(k) pathway after a 164-day FDA review.

K060677 · Dade Behring, Inc. · Chemistry device
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Aug 2006
Decision
164d
Days
Class 1
Risk

K060677 is an FDA 510(k) clearance for the N LATEX CDT. Classified as Test, Carbohydrate Deficient Transferrin (product code NAO), Class I - General Controls.

Submitted by Dade Behring, Inc. (Newark, US). The FDA issued a Cleared decision on August 25, 2006 after a review of 164 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1360 - 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 Dade Behring, Inc. devices

FDA 510(k) Submission Details - K060677

510(k) Number K060677 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 2006
Decision Date August 25, 2006
Days to Decision 164 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
76d slower than avg
Panel avg: 88d · This submission: 164d
Pathway characteristics
Predicate-based equivalence.

NAO Device Classification - Class 1, General Controls

Product Code NAO Test, Carbohydrate Deficient Transferrin
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1360
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.