Cleared Traditional

K231776 - Cell-Free DNA BCT (FDA 510(k) Clearance)

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

K231776 · Streck, Inc. · Chemistry device
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Jul 2024
Decision
406d
Days
Class 2
Risk

K231776 is an FDA 510(k) clearance for the Cell-Free DNA BCT. Classified as Blood Collection Device For Cell-free Nucleic Acid (product code QMA), Class II - Special Controls.

Submitted by Streck, Inc. (La Vista, US). The FDA issued a Cleared decision on July 26, 2024 after a review of 406 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1676 - 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 Streck, Inc. devices

Submission Details

510(k) Number K231776 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 2023
Decision Date July 26, 2024
Days to Decision 406 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
318d slower than avg
Panel avg: 88d · This submission: 406d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QMA Blood Collection Device For Cell-free Nucleic Acid
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1676
Definition A Blood Collection Device For Cell-free Nucleic Acids Is A Device Intended For Medical Purposes To Collect, Store, Transport, And Handle Blood Specimens And To Stabilize And Isolate Cell-free Nucleic Acid Components Prior To Further Testing.
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.