Cleared Traditional

K230878 - QScout Lab

Also marketed or referenced as:
QScout RLD

K230878 is an FDA 510(k) clearance for QScout Lab, manufactured by Ad Astra Diagnostics, Inc.. The device is a Class 2 Hematology device with product code GKZ cleared through the Traditional 510(k) pathway after a 229-day FDA review.

K230878 · Ad Astra Diagnostics, Inc. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2023
Decision
229d
Days
Class 2
Risk

K230878 is an FDA 510(k) clearance for the QScout Lab. Classified as Counter, Differential Cell (product code GKZ), Class II - Special Controls.

Submitted by Ad Astra Diagnostics, Inc. (Morrisville, US). The FDA issued a Cleared decision on November 14, 2023 after a review of 229 days - an extended review cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5220 - the FDA hematology device 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 Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all Ad Astra Diagnostics, Inc. devices

FDA 510(k) Submission Details - K230878

510(k) Number K230878 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 2023
Decision Date November 14, 2023
Days to Decision 229 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
116d slower than avg
Panel avg: 113d · This submission: 229d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GKZ Device Classification - Class 2, Special Controls

Product Code GKZ Counter, Differential Cell
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5220
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 Hematology devices follow this clearance model.

Regulatory Peers - GKZ Counter, Differential Cell

All 226
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