510(k) · Cleared

Recalled · 2007

Roche Amplichip CYP450 Test

K043576510(k) TraditionalCleared Jan 10, 200514-day reviewClass II21 CFR 862.3360Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Roche Molecular Systems, Inc. · NTI Drug Metabolizing Enzyme Genotyping Systems

Cleared on Jan 10, 2005 as substantially equivalent to DEN040011 (Roche Molecular Systems, Inc., 2004) after a 14-day review. Its family tree reaches back 1 generation to 2004. 8 later devices descend from it. It has been recalled once.

Decided: Jan 10, 2005
Review: 14 days
Class: Class II
Product code: NTI
Recalls: 1
Predicates: 1

Its longest line of descent runs back 1 generation to DEN040011 (2004). 8 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 1 generation backDEN040011 Amplichip CYP450 Test, Model 04381866190Roche Molecular Systems, Inc. · 2004
This deviceK043576 Roche Amplichip CYP450 TestRoche Molecular Systems, Inc. · 2005
Descendant · cites it directly · 4 of its ownK073014 Infiniti 2C9 & VKORC1 Multiplex Assay for WarfarinAutogenomics, Incorporated · 2008
Descendant · cites it directly · 3 of its ownK101683 Infiniti CYP2C19 AssayAutogenomics, Incorporated · 2010
Descendant · cites it directly · 2 of its ownK051824 Invader UGT1A1 Molecular AssayThird Wave Technologies, Inc. · 2005
Descendant · 2 generations on · 1 of its ownK123891 Spartan RX CYP2C19 Test SystemSpartan Bioscience, Inc. · 2013
Descendant · 2 generations on · 1 of its ownK070804 Verigene System, Verigene Warfarin Metabolism Nucleic Acid TestNanosphere, Inc. · 2007 · Recalled

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2005high 1 (2005) · low 0 (2006)2026

Most influential descendants

Showing 5 of 8 · See all

K073014Infiniti 2C9 & VKORC1 Multiplex Assay for WarfarinAutogenomics, Incorporated · 2008 · cites it directly4descendants
K101683Infiniti CYP2C19 AssayAutogenomics, Incorporated · 2010 · cites it directly3descendants
K051824Invader UGT1A1 Molecular AssayThird Wave Technologies, Inc. · 2005 · cites it directly2descendants
K123891Spartan RX CYP2C19 Test SystemSpartan Bioscience, Inc. · 2013 · 2 generations on1descendant
K070804Verigene System, Verigene Warfarin Metabolism Nucleic Acid TestNanosphere, Inc. · 2007 · 2 generations on1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	DEN040011	Amplichip CYP450 Test, Model 04381866190	Roche Molecular Systems, Inc.	2004	—
0 (this device)	K043576	Roche Amplichip CYP450 Test	Roche Molecular Systems, Inc.	2005	—
+1	K073014	Infiniti 2C9 & VKORC1 Multiplex Assay for Warfarin	Autogenomics, Incorporated	2008	—
+1	K101683	Infiniti CYP2C19 Assay	Autogenomics, Incorporated	2010	—
+1	K051824	Invader UGT1A1 Molecular Assay	Third Wave Technologies, Inc.	2005	—
+2	K123891	Spartan RX CYP2C19 Test System	Spartan Bioscience, Inc.	2013	—
+2	K070804	Verigene System, Verigene Warfarin Metabolism Nucleic Acid Test	Nanosphere, Inc.	2007	1

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	1	0
2007	1	0
2008	1	0
2009	1	0
2010	1	0
2012	1	0
2013	1	0
2023	1	0

FIG. 1 — Lineage of K043576, 2004–2023Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in NTI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new NTI device

#1 K220026 Genomadix Cube CYP2C19 Systemscore 6.2 · 5 generations · no Class I recall

Get a 510(k) Report

What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	DEN040011	Amplichip CYP450 Test, Model 04381866190 Our reading of the summary gave K042259, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN040011, Amplichip CYP450 Test, Model 04381866190 (Roche Molecular Systems, Inc.), granted Dec 23, 2004; older De Novo requests were first filed under a 510(k) number, so this links to the grant.	Roche Molecular Systems, Inc.	2004	—

Also cleared against DEN040011: 1 other device →

What descends from it? (8)

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K073014	Infiniti 2C9 & VKORC1 Multiplex Assay for Warfarin	Autogenomics, Incorporated	2008	4
K101683	Infiniti CYP2C19 Assay	Autogenomics, Incorporated	2010	3
K051824	Invader UGT1A1 Molecular Assay	Third Wave Technologies, Inc.	2005	2

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Mar 9, 2007	Not classified	Z-0734-2007	Other	The current package insert for the AmpliChip CYP 450 test, lists an incorrect part number for DNase I. The DNase is listed in the "Other Materials Required" section as 'DNase I rec., RNase-free, P/N 04716728001 (Roche Applied Science)" .…

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
Of its descendants, K073014 (Autogenomics, Incorporated, 2008) has gone furthest, with 4 descendants of its own.
1 other device also cites its predicate DEN040011.

How does its category compare?

All NTI devices

NTI Drug Metabolizing Enzyme Genotyping Systems: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · NTI

1in 2023

2007high 3 (2013) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NTI

116in 2013

2007high 116 (2013)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · NTI

1in 2011

2007high 2 (2007) · low 0 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · NTI

2in 2011

2007high 2 (2011) · low 0 (2008)2025

MAUDE reports naming product code NTI, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	0	—	2	1
2008	0	—	0	0
2009	0	—	0	1
2010	2	—	0	1
2011	0	—	1	2
2012	1	—	0	0
2013	3	116	0	0
2014	0	—	0	0
2015	0	—	0	0
2016	0	—	0	0
2017	1	—	0	0
2018	0	—	0	0
2019	0	—	0	0
2020	0	—	0	0
2021	0	—	0	0
2022	0	—	0	0
2023	1	—	0	0
2024	0	—	0	0
2025	0	—	0	0
2026	0	—	0	—

What is it indicated for?

The Roche AmpliChip CYP450 test is intended to identify a patient's CYP2C19 genotype from genomic DNA extracted from a whole blood sample. Information about CYP2C19 genotype may be used as an aid to clinicians in determining therapeutic strategy and treatment dose for therapeutics that are metabolized by the CYP2C19 gene product.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K043576 · printed Nov 6, 2026

Cite this page

510(k) Report. “K043576: Roche Amplichip CYP450 Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K043576

Report an extraction error

Are you the manufacturer?

Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026