Cleared Traditional

K221640 - AlloMap Heart Molecular Expression Testing (FDA 510(k) Clearance)

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

K221640 · Caredx, Inc. · Chemistry device
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Sep 2023
Decision
464d
Days
Class 2
Risk

K221640 is an FDA 510(k) clearance for the AlloMap Heart Molecular Expression Testing. Classified as Cardiac Allograft Gene Expression Profiling Test System (product code OJQ), Class II - Special Controls.

Submitted by Caredx, Inc. (Brisbane, US). The FDA issued a Cleared decision on September 13, 2023 after a review of 464 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1163 - 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 Caredx, Inc. devices

Submission Details

510(k) Number K221640 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 06, 2022
Decision Date September 13, 2023
Days to Decision 464 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
376d slower than avg
Panel avg: 88d · This submission: 464d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OJQ Cardiac Allograft Gene Expression Profiling Test System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1163
Definition In Vitro Diagnostic Multivariate Index Assay (ivdmia) Test Service, Performed In A Single Laboratory, For Assessing The Gene Expression Profile Of Rna Isolated From Peripheral Blood Mononuclear Cells (pbmc) And Indicated For Use To Aid In The Identification Of Heart Transplant Recipients With Stable Allograft Function Who Have A Low Probability Of Moderate/severe Acute Cellular Rejection (acr) At The Time Of Testing In Conjunction With Standard Clinical Assessment.
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.