The 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.

Device Description

The AmpliChip CYP450 Test is based on five major processes: PCR amplification of purified DNA: fragmentation and labeling of the amplified products; hybridization of the amplified products to a microarray and staining of the bound products; scanning of the microarray; and determination of the CYP450 genotype and predicted phenotype.

The AmpliChip CYP450 Test is designed to identify specific nucleic acid sequences and query for the presence of known sequence polymorphisms through analysis of the pattern of hybridization to a series of probes that are specifically complementary either to wildtype or mutant sequences. Microarrays of oligonucleotide probes synthesized on a glass substrate are utilized for the analysis.

AI/ML Overview

The provided document describes the performance of the AmpliChip CYP450 Test for CYP2C19. Here's an analysis based on your request:

Acceptance Criteria and Device Performance

The document doesn't explicitly state "acceptance criteria" as a separate section with predefined thresholds. Instead, it presents performance data from non-clinical studies (Limit of Detection, Specificity, Genotype Detection, Whole System Failure, Cross Contamination, Reproducibility, Interference Studies) and implicitly demonstrates that the device meets the expected performance for a diagnostic tool of this nature. The "Percent Agreement" values (often ≥99%) and "Positivity Rate" (100% at relevant DNA concentrations) serve as de facto performance targets that the device achieved.

Here's a table summarizing the reported device performance, with implicit acceptance criteria derived from the presented results:

Performance Metric	Implicit Acceptance Criteria (Achieved)	Reported Device Performance
Limit of Detection (LoD)	≥95% positivity rate for correct genotype detection at 25 ng DNA/mL.	100% positivity rate at 50 ng DNA/mL (144/144 correct calls). 100% positivity rate at 25 ng DNA/mL (144/144 correct calls). 93.1% positivity rate at 2.5 ng DNA/mL (134/144 correct calls). The lowest level for ≥95% was considered 25 ng and 2.5 ng (the document states "25 and 2.5 ng" without further clarification, but the table shows 100% for 25ng and 93.1% for 2.5ng).
Specificity	100% correct identification of wild-type samples.	100% (270/270 correct calls for 1/1 genotype).
Genotype Detection	High agreement (e.g., ≥99%) with sequencing for individual alleles and overall genotype call rate.	Sequencing Concordance (Alleles): Overall agreement: 99.6% (245/246 correct calls). Individual allele agreement: 1 (100%), 2 (98.7%), 3 (100%). Overall Genotype Call Rate:* 99.7% for all 399 tested samples. Overall Percent Agreement: 99.7% for all 399 tested samples.
Whole System Failure	Low failure rate (e.g., <5%).	1% (1/100 replicates, due to inability to scan microarray). 95% CI: 94.55% - 99.97%. 0% failure due to amplification and detection reagents.
Cross Contamination	No observable cross-contamination.	No carryover contamination observed (appropriate CYP2C19 genotype obtained for all specimens in alternating runs).
Reproducibility	High genotype call rate and correct call rate across sites, operators, and reagent lots (e.g., ≥99%).	Genotype Call Rate: 99.8% (807/809 samples). Correct Genotype Calls: 99.9% (806/807 for 1/1, 100% for other genotypes). Overall correct call rate estimate: 1.00 (0.99 95% CI).
Interference Studies	No interference from elevated levels of common endogenous interfering substances (albumin, bilirubin, lipids).	No interference demonstrated from elevated levels of lipids, bilirubin, and albumin.

Study Details

Here's the breakdown of the study details according to your requested points:

A table of acceptance criteria and the reported device performance:
(Provided above)
Sample size used for the test set and the data provenance:
- Limit of Detection: 144 arrays per DNA concentration (two genomic DNA samples).
- Specificity: 270 samples (*1/*1 genotype).
- Genotype Detection (Sequencing Concordance): 123 samples (246 alleles in total analyzed by sequencing).
- Genotype Detection (Overall): 399 unique samples (796 unique alleles)
- Whole System Failure: 100 replicates of genomic DNA from one whole blood specimen.
- Cross Contamination: 5 runs of alternating two specimens of distinct genotype.
- Reproducibility: 6-member panel tested in triplicate for 5 runs by one operator at each of 3 sites, using 3 lots of reagents. (Total 809 results).
- Interference Studies: 10 random whole blood specimens collected in EDTA.
Data Provenance: The document does not explicitly state the country of origin for the samples. It mentions "genomic DNA purified from a whole blood specimen" and "cell lines," implying human biological samples. It is a non-clinical study, focusing on assay performance rather than patient outcomes, and therefore likely based on retrospective samples or controlled-condition samples for analytical validation.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

The ground truth for the test set was established using established molecular methods, not human expert consensus.
- Reference methods included: Bi-directional DNA sequencing, allele-specific PCR, and PCR-RFLP.
- The document does not specify the number or qualifications of individuals who performed these reference methods. This is typical for molecular diagnostic device submissions, where the "ground truth" is analytical (e.g., precise sequence determination) rather than subjective human interpretation.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:

No adjudication method involving multiple human readers is mentioned as the ground truth was established by definitive molecular methods (sequencing, PCR-RFLP). Comparisons were made between the AmpliChip results and these reference methods. For example, in Genotype Detection, "DNA sequence analysis for genotype confirmation was performed" and "additional samples were evaluated by established methods including allele-specific PCR and PCR-RFLP in order to determine the reference CYP2C19 genotype."
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or described. This device is a molecular diagnostic assay for genotyping, not an image-based AI system that would assist human readers in interpretation. Therefore, the concept of "human readers improve with AI vs without AI assistance" does not apply to this type of device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Yes, the performance studies described are essentially standalone algorithm (device) performance. The AmpliChip CYP450 Test is an automated assay system (PCR amplification, hybridization to microarray, scanning, genotype determination). Its performance metrics (Limit of Detection, Specificity, Genotype Detection, etc.) are evaluating the device's ability to accurately determine genotypes independently. There is no human "in the loop" performing interpretation that the device is assisting; rather, the device is providing the direct result.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The ground truth used was based on molecular reference methods, specifically:
- Bi-directional DNA sequencing
- Allele-specific PCR
- PCR-RFLP (Restriction Fragment Length Polymorphism)
These are considered definitive analytical methods for determining genetic sequences and polymorphisms.
The sample size for the training set:

This document describes a 510(k) submission for a diagnostic device, which is typically based on pre-analytical validation, not machine learning model training. Therefore, there is no mention or concept of a "training set" in the context of machine learning. The studies described are performance validation tests.
How the ground truth for the training set was established:

Since there is no training set in the machine learning sense, this question is not applicable. The device's underlying principles are based on molecular biology (hybridization to probes), not an algorithm that learns from a training dataset. The "ground truth" for the analytical validation was established by the definitive molecular reference methods listed in point 7.

Summary

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AmpliChip CYP450 Test Section 4: Summary 510(k) Summary Report

K043576

AmpliChip CYP450 Test for CYP2C19 510(k) Summary

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1.	Device Name	1
2.	Identification of the Legally Marketed Device to Which Is Claimed Equivalence	1
3.	Description of the Device	1
4.	Intended Use of the Device	1
5.	Summary of the Technological Characteristics of the Device Compared to thePredicate Device	2
6.	Performance Data from the Non-Clinical Studies	2
	6.1. Limit of Detection	2
	6.2. Specificity	2
	6.3. Genotype Detection	3
	6.3.1. Performance Compared to Other CYP450 GenotypingMethods	5
	6.4. Whole System Failure	5
	6.5. Cross Contamination	6
	6.6. Reproducibility	6
	6.7. Interference Studies	7
	6.8. Conclusions	7
7.	Clinical Validity	8
	7.1. Geographic Distribution of Allele Frequencies	9

List of Tables

Table 1: Limit of Detection for the CYPC19 Gene	2
Table 2: Specificity for the CYPC19 Gene	3
Table 3: Sequencing Concordance for CYP2C19 Alleles	4
Table 4: Detection of CYP2C19 Alleles	4
Table 5: Detection of Samples by CYP2C19 Genotype	5
Table 6: Reference Method for CYP2C19 Allele Identification	5

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Table 7: AmpliChip CYP450 Test Panel	6
Table 8: Reproducibility Panel Results for CYPC19 Genotype	7
Table 9: Clinically Relevant Drug Substrates for Metabolism byCYP2C19 Enzymes	8
Table 10: Geographic Differences in CYP2C19 Allelic Frequencies	9

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DEVICE NAME 1.

Trade or Proprietary Name: AmpliChip CYP450 Test

Common or Usual Name: Cytochrome P450 CYP2C19 Test

Classification Name: 21 CRF 862.3360 - Drug Metabolizing Enzyme Genotyping System

IDENTIFICATION OF THE LEGALLY MARKETED DEVICE TO WHICH IS 2. CLAIMED EQUIVALENCE

The AmpliChip CYP450 Test for CYP2C19 is equivalent to the AmpliChip CYP450 Test for CYP2D6 (510(k) Premarket Notification K042259, submitted August 20, 2004).

3. DESCRIPTION OF THE DEVICE

4. INTENDED USE OF THE DEVICE

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SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE 5. DEVICE COMPARED TO THE PREDICATE DEVICE

The technological characteristics of the AmpliChip CYP450 Test for CYP2C19 are identical to those of the AmpliChip CYP450 Test for CYP2D6 (K042259).

6. PERFORMANCE DATA FROM THE NON-CLINICAL STUDIES

6.1. Limit of Detection

The limit of detection of the AmpliChip CYP450 Test was determined by analysis of dilutions of two genomic DNA samples to 0.1, 1 and 2 ng DNA/mL. The concentration of the DNA samples was determined by use of a PicoGreen double stranded DNA Quantitation kit. The DNA samples were * 2/* 2 and * 1/* 1 for the CYP2C19 gene. The % positivity rate was determined from the number of correct genotype calls. The lowest level of genomic DNA at which a ≥ 95% positivity rate was obtained for correct detection of the CYP2C19 gene was 25 and 2.5 ng.

DNA Amount(ng)	Number ofArrays	Number ofCorrect Calls	Positivity Rate	95% ConfidenceLimit
50	144	144	100%	97.5 – 100%
25	144	144	100%	97.5 – 100%
2.5	144	134	93.1%	87.6 – 96.6%

Table 1: Limit of Detection for the CYPC19 Gene

6.2. Specificity

Specificity of the AmpliChip CYP450 Test was evaluated using genomic DNA samples at approximately 2 ng/mL. Results were recorded as correct genotype calls, or miscalls. Established methods including allele-specific PCR, PCR-RFLP, and DNA sequence analysis were used to establish the reference CYPC19 genotype for the samples.

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Two hundred seventy (270) samples containing one CYP2C19 allele with normal predicted enzymatic activity (*1 allele) were tested.

The specificity of the AmpliChip CYP450 Test was calculated by determining the percentage of tested wild-type samples with the correct wild-type genotype identified, as compared to the total number of wild-type samples tested. The specificity of the AmpliChip CYP450 Test for detection of wild-type samples was 100% for the CYP2C19 gene.

CYP2C196 Genotype	Number of SamplesTested	Number ofCorrect Calls	Number of Miscalls
1/1	270	270	0

Table 2: Specificity for the CYPC19 Gene

6.3. Genotype Detection

Method comparison studies were performed using bi-directional DNA sequencing as the comparator for the AmpliChip CYP450 test. DNA sequence analysis for genotype confirmation was performed for 123 samples with CYP2C19 genotype that had been previously analyzed by the AmpliChip CYP450 Test. One sample that was identified as CYP2C19 *2/*2 genotype by RFLP and by the AmpliChip CYP450 Test was shown by sequencing to be a CYP2C19 *2/*10 genotype. With this single miscall, the agreement between the AmpliChip CYP450 Test and sequencing for CYP2C19 alleles was 99.6%.

The results for each allele analyzed in this manner are presented below in Table 3 for CYP2C19 alleles.

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CYP2C19Allele	Number ofAllelesSequenced	AmpliChip Results			PercentAgreement
		Correct Calls	Miscalls	NoCalls
*1	153	153	0	0	100.0%
*2	79	78	11	0	98.7%
*3	14	14	0	0	100.0%
Total	246	245	0	0	99.6%

Table 3: Sequencing Concordance for CYP2C19 Alleles

\ One sample, identified as CYP2C19 *2/*2 by RFLP and the AmpliChip CYP450 Test, was shown by sequencing to be a CYP2C19 *2/10 genotype.

Genotype detection was evaluated using genomic DNA samples at approximately 50 ng/PCR. In addition to the sequencing confirmation presented above, additional samples were evaluated by established methods including allele-specific PCR and PCR-RFLP in order to determine the reference CYP2C19 genotype for the samples. The percent agreement for genotype detection of the AmpliChip CYP450 Test was calculated by determining the percentage of tested samples with the correct genotype assigned as compared to the total number of samples tested of that genotype.

Genotype detection results for CYP2C19 were calculated for the individual alleles (Table 4) and by sample (Table 5). The overall genotype call rate and percent agreement for CYP2C19 were both 99.7% for all 399 tested samples.

CYP2C19Allele	Number of UniqueAlleles Tested	Number ofCorrect Calls	Number ofMiscalls	PercentAgreement	Number ofReplicates
*1	647	647	0	100%	842
*2	137	136	1	99.3%	176
*3	14	14	0	100%	32
Total	796	796	0	99.9%	1050

Table 4: Detection of CYP2C19 Alleles

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CYP2C19Genotype	Total UniqueSamples	Number ofCorrect calls	Number ofMiscalls	PercentAgreement	GenotypeCall Rate
1/1	270	270	0	100.0%	100.0%
1/2	101	101	0	100.0%	100.0%
1/3	6	6	0	100.0%	100.0%
2/2	15	14	11	93.3%	93.3%
2/3	6	6	0	100.0%	100.0%
3/3	1	1	0	100.0%	100.0%
Total	399	398	1	99.7%	99.7%

Table 5: Detection of Samples by CYP2C19 Genotype

4 One sample, shown by sequencing to be CYP2C19 2/ 10*, was miscalled as a CYP2C19 *2/*2 genotype.

Performance Compared to Other CYP450 Genotyping Methods 6.3.1.

The sensitivity and specificity of the identification of the CYP2C19 alleles was determined as compared to PCR-RFLP and DNA sequencing. The results are summarized in Table 6.

Table 6: Reference Method for CYP2C19 Allele Identification

Method(s)	Number ofSamples Tested	Number ofCorrect Calls	Number ofMiscalls	Number ofNo Calls
PCR-RFLP	276	276	0	0
DNA Sequencing and PCR-RFLP	123	122	1	0

6.4. Whole System Failure

The robustness of the AmpliChip CYP450 Test was evaluated by testing 100 replicates of genomic DNA purified from a whole blood specimen using the QIAamp DNA Blood kit. The test solution contained approximately 50 ng DNA/PCR of *1/*1 CYP2C19 genotype. There was one System Failure event where no result was obtained due to inability to scan the stained AmpliChip CYP450 Microarray resulting in a Whole System

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Failure rate of 1% with a 95% confidence interval from 94.55 - 99.97% due to the instrument or the AmpliChip CYP450 Microarray. There was a 0% Whole System Failure rate due to the AmpliChip CYP450 Test amplification and detection reagents.

Of the 100 valid replicates, one chip failed to scan the initial and subsequent attempts resulting in failure.

Cross Contamination 6.5.

Potential carryover contamination was assessed with five runs of alternating two specimens of distinct genotype, along with the appropriate controls. The position of the specimens plus controls was varied between the runs. No carryover contamination was observed; the appropriate CYP2C19 genotype was obtained for all specimens.

Reproducibility 6.6.

To evaluate the reproducibility of the AmpliChip CYP450 Test a six-member panel was constructed from cell lines that represent all known 2C19 alleles. The Reproducibility Panel samples were tested at a concentration of 50 ng DNA/PCR. The genotype and ' predicted phenotype (extensive metabolizer) of the Reproducibility Panel samples are provided in Table 7.

CYP2C19 Genotype	Predicted Phenotype
1 / 1	Extensive
1 / 2	Extensive
1 / 3	Extensive
1 / 1	Extensive
1 / 2	Extensive
1 / 2	Extensive

Table 7: AmpliChip CYP450 Test Panel

Testing was conducted at three sites; including two external sites and a laboratory at Roche Molecular Systems. The Reproducibility Panel was tested in triplicate for five runs by one operator at each of the three sites, using three lots of reagents.

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The 809 results from this study are summarized in Table 8. Genotype calls for CYP2C19 were made for 807/809 (99.8%) samples. Two results did not provide a genotype call. There was one incorrect call for CYP2C19 *1/*1 (99.9% [806/807] correct).

CYP2C19 genotype	PredictedPhenotype	No.Tested	GenotypeCallsN (%)	CorrectGenotypeCalls	Correct CallRate Estimate(95% CI)
1 / 1	Extensive	134	134 (100.0)	133	0.99 (0.97)
1 / 2	Extensive	135	135 (100.0)	135	1.00 (0.98)
1 / 3	Extensive	135	135 (100.0)	135	1.00 (0.98)
1 / 1	Extensive	135	135 (100.0)	135	1.00 (0.98)
1 / 2	Extensive	135	134 (99.3)	134	1.00 (0.98)
1 / 2	Extensive	135	134 (99.3))	134	1.00 (0.98)
Total		809	807 (99.8)	806	1.00 (0.99)

Table 8: Reproducibility Panel Results for CYPC19 Genotype

Interference Studies 6.7.

Ten random specimens of whole blood collected in EDTA, adjusted to a level approximating or exceeding 50 ng DNA/PCR were tested in the absence of, and with, elevated levels of one of three potential endogenous interfering substances (albumin, bilirubin or lipids). The endogenous interfering substances were spiked into the specimens from concentrated stock solutions to at high-test levels as defined by the Clinical and Laboratory Standards Institute. These test levels were intended to reproduce the states of hyperalbuminemia, icterus and lipemia in native specimens. Results from this study demonstrated that elevated levels of lipids, bilirubin and albumin in specimens do not to interfere with the performance of the AmpliChip CYP450 Test.

6.8. Conclusions

The AmpliChip CYP450 Test accurately identifies the CYP2C19 genotype of clinical specimens using DNA purified from human blood.

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CLINICAL VALIDITY 7.

Individual differences in metabolic rates alter the expected relationship between the dose of a drug and its concentration in the blood or the length of time it stays in the blood. Therefore, a polymorphism in the CYP2C19 enzymes can lead to excessive or prolonged therapeutic effect or drug-related toxicity after administration of a "typical" dose by failing to clear a drug from the blood or by changing the pattern of metabolism to produce toxic metabolites. This is particularly true of drugs with a narrow therapeutic index. Adjustment of drug dosage could be beneficial based upon knowledge of these differences in metabolism, particularly for individuals possessing the poor metabolizer phenotype. Table 9 lists some clinically relevant drugs that are known substrates of CYP2C19 enzymes.

Table 9: Clinically Relevant Drug Substrates for Metabolism by CYP2C19 Enzymes

Proton Pump Inhibitors	Anti-epileptics	Others
Omeprazole	Diazepam	Amitriptyline
Lansoprazole	Phenytoin	Clomipramine
Pantoprazole	Phenobarbitone	Cyclophosphamide
		Progesterone

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Geographic Distribution of Allele Frequencies 7.1.

The vast majority of poor CYP2C19 metabolizers are accounted for by the two common CYP2C192 and CYP2C193 alleles. Each of these null alleles is caused by a single nucleotide polymorphism that either causes a splice site defect or a stop codon. These two alleles are quite common among Asian populations where approximately 13-23% exhibit the poor metabolizer phenotype. The CYP2C19 poor metabolizer phenotype is present in about 3-5% of Caucasian and African-American populations.

Allele	Predicted Enzymatic Activity	Chinese	Black	Caucasian
*1	Normal
*2	None	30%	17%	15%
*3	None	5%	<1%	<1%

Table 10: Geographic Differences in CYP2C19 Allelic Frequencies

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Image /page/12/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JAN I 0 2005

James F. Kelly, Ph.D. Roche Molecular Systems, Inc. 4300 Hacienda Drive Pleasanton, CA 94588

K043576 Re:

Trade/Device Name: AmpliChip CYP450 Test Regulation Number: 21 CFR 862.3360 Regulation Name: Drug Metabolizing Enzyme Genotyping Regulatory Class: Class II Product Code: NTI Dated: December 23, 2004 Received: December 27, 2004

Dear Dr. Kelly:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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This letter will allow you to begin marketing your device as described in your Section 510(k) I ms letter will anow you to organization of substantial equivalence of your device to a legally promative notification " " = " = " = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, r you decire on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240)276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the I va may of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely yours,

Cornelia B. Rooks

Cornelia B. Rooks, MA Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Statement of Indications for Use

510(k) Number (if known):

043576

Device Name:

AmpliChip CYP450 Test

Indications for Use

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.

× Over-The-Counter Use AND/OR Prescription Use (21 CFR 801 Subpart C) (Per 21 CFR 801 Subpart D)

PLEASE DO NOT WRITE BELOW THIS LINE — CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)
Division Sign-Off

	acting
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Office of In Vitro Diagnostic
Device Evaluation and Safety

510(k)	K043576
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Page 1 of 1CONFIDENTIAL AND PROPRIETARY

Indications for Use Statement Page 1

Regulation Number and Section

§ 862.3360 Drug metabolizing enzyme genotyping system.

(a)
Identification. A drug metabolizing enzyme genotyping system is a device intended for use in testing deoxyribonucleic acid (DNA) extracted from clinical samples to identify the presence or absence of human genotypic markers encoding a drug metabolizing enzyme. This device is used as an aid in determining treatment choice and individualizing treatment dose for therapeutics that are metabolized primarily by the specific enzyme about which the system provides genotypic information.(b)
Classification. Class II (special controls). The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: Drug Metabolizing Enzyme Genotyping Test System.” See § 862.1(d) for the availability of this guidance document.