The VeraCode Genotyping Test for Factor V and Factor II is an in vitro diagnostic device for the detection and genotyping of Factor V Leiden G1691A and Factor II (Prothrombin) G20210A point mutations in DNA obtained from EDTA-anticoagulated human blood samples. The test is intended for use on the BeadXpress System. The VeraCode Genotyping Test for Factor V and Factor II on the BeadXpress System is indicated for use as an aid to diagnosis in the evaluation of patients with suspected thrombophilia.

Device Description

The VeraCode Genotyping Test for Factor V and Factor II assay consists of reagents sufficient for 96 tests, consisting of two boxes containing pre-PCR and post-PCR reagents. The pre-PCR box contains the following reagents: MTR1 (1 x 1.2 mL). AB1 (1 x 4 mL), AOP1 (1 x 4.8 mL), ELM (1 x 4.8 mL), FSB (1 x 4.8mL), UB3 buffer (2 x 4.8 mL) and AE1 reagent (2 x 4.8 mL). The post-PCR box contains MSS reagent (1 x 4.8 mL) and Fast Start Taq DNA Polymerase (1 x 60 µL), VW2 buffer (1 x 60 mL), a VeraCode FV/FII Bead Plate with holographically inscribed glass microbeads aliquoted in strip-well plates, a test-specific kit manifest file and sample sheet files (containing test specific outcome specifications and sample plate layout files used to interpret and report genotype results). A magnet plate is also required but sold separately.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study details for the Illumina VeraCode® Genotyping Test for Factor V and Factor II, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The device's performance is primarily evaluated through reproducibility (precision) and accuracy (method comparison).

Acceptance Criteria for Reproducibility (Precision):
While explicit numerical acceptance criteria for reproducibility are not stated as "acceptance criteria," the study aimed to demonstrate high agreement for correct calls across different operators, sites, and days. The results presented in the summary show very high percentage agreements and 95% lower confidence bounds (LCB) nearing 100% after retesting, indicating that the implicit acceptance criterion was near-perfect agreement for calling genotypes correctly.

Test Parameter	Acceptance Criteria (Implicit)	Reported Device Performance (After Retest)
Reproducibility	High percentage agreement (>95%) and 95% LCB for correct genotype calls across sites, operators, and days.	Factor V: `Wild Type`: 100% agreement (99.38% LCB); `Heterozygous`: 99.58% agreement (98.04% LCB); `Homozygous`: 100% agreement (98.35% LCB). All initially "no calls" (failures) were resolved upon re-test. Factor II: `Wild Type`: 100% agreement (99.45% LCB); `Heterozygous`: 100% agreement (98.35% LCB); `Homozygous`: 100% agreement (98.35% LCB). All initially "no calls" (failures) were resolved upon re-test.
Accuracy	High overall percent agreement (>95%) and 95% LCB compared to bi-directional DNA sequencing for genotype calls.	Factor V: `Wild Type`: 100% agreement (98.6% LCB); `Heterozygous`: 100% agreement (94.07% LCB); `Homozygous`: 92.86% agreement (70.33% LCB) with one of the 14 samples still being a "no call" after repeat testing. Factor II: `Wild Type`: 99.59% agreement (98.08% LCB); `Heterozygous`: 100% agreement (88.27% LCB); `Homozygous`: 100% agreement (65.18% LCB).

Note: The 95% LCB for homozygous Factor V (70.33%) and Factor II (65.18%) in the accuracy study, while lower than other categories, likely reflect the smaller sample size for these less common genotypes.

2. Sample Size and Data Provenance for the Test Set

Test Set Sample Size:
- Reproducibility (Precision) Study: A panel of 15 genomic DNA samples (3 for each of the 5 possible genotypes including Wild Type). Each sample was tested in duplicate once a day for 5 non-consecutive days at each of three sites by two operators. This results in a significant number of replicates (e.g., for Factor V Wild Type, 3 samples * 2 replicates * 5 days * 3 sites * 2 operators = 180 total instances, with slight variations in the tables indicating initial no-calls).
- Accuracy (Method Comparison) Study: 92 patient samples were accrued at each of the three sites, yielding a total of 276 patient samples. Additionally, each site received two archived DNA samples as positive controls.
Data Provenance: The report does not explicitly state the country of origin. However, the samples for the accuracy study were "prospectively drawn blood samples" (for interference testing) and "pre-selected or unscreened patients undergoing Factor V testing" (for method comparison), suggesting a combination of prospective and retrospective (archived) samples for the accuracy study. For reproducibility, it uses "genomic DNA samples isolated from blood" and "commercially available cultured cells."

3. Number of Experts and Qualifications for Ground Truth

Number of Experts: For the accuracy study (method comparison), the ground truth was established by "bi-directional DNA sequencing analysis performed at an independent reference laboratory." The number of individuals/experts involved in this independent sequencing and interpretation is not specified, nor are their specific qualifications (e.g., number of years of experience). However, "bi-directional DNA sequencing" is a well-established and highly accurate method for genotyping, implying expert-level analysis.

4. Adjudication Method for the Test Set

There appears to be no explicit adjudication method described for resolving discrepancies between the device's results and the ground truth (bi-directional sequencing). The summary reports the raw agreement.
For the device's own internal "no calls" (samples generating an invalid result), the "no calls" were retested once. This retesting resolved most, but not all, initial "no calls," as seen in the tables (e.g., one FVL Homozygous sample in the accuracy study remained a "no call" after retesting).

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done. This device is an in vitro diagnostic (IVD) genetic test, which typically has a standalone performance assessment against a gold standard (like sequencing) rather than evaluating human reader performance with or without AI assistance.

6. Standalone Performance Study (Algorithm Only)

Yes, a standalone performance study was done. The entire analytical performance section (Precision/Reproducibility and Method Comparison) describes the performance of the device (VeraCode Genotyping Test for Factor V and Factor II on the BeadXpress System, with VeraScan software) as a standalone system. The results of the device were directly compared against the established ground truth (bi-directional sequencing), without human intervention in the interpretation process of the device's output. The software interprets and reports the genotype.

7. Type of Ground Truth Used

The primary ground truth used for both the reproducibility and accuracy studies was bi-directional DNA sequencing. This is considered a highly reliable and definitive method for determining gene mutations.

8. Sample Size for the Training Set

The document does not provide information on the sample size used for the training set. As a 510(k) submission for a diagnostic test kit based on established molecular biology principles (PCR, allele-specific primer extension, hybridization), the development of the "algorithm" (the VeraScan software and kit manifest file) would typically rely on well-characterized samples and biochemical parameters rather than a large machine learning training set in the modern sense. The "assay-specific kit manifest file" contains the parameters and cutoffs used to interpret and report genotype results, implying these were established during development.

9. How the Ground Truth for the Training Set Was Established

Similar to the training set sample size, the document does not explicitly detail how ground truth for the training set (development of the kit manifest and software interpretation rules) was established. It's inferable that the development team used well-characterized reference samples (likely with known genotypes confirmed by sequencing or other gold-standard methods) to define the assay parameters, thresholds, and interpretation rules encoded in the kit manifest file that guides the VeraScan software. The "Preliminary passing criteria where all replicates of all genotypes produce the correct result when compared to bi-directional sequencing" mentioned in the detection limit section suggests an iterative process referencing sequencing during development.

Summary

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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

A. 510(k) Number: K093129

B. Purpose for Submission: New Device
C. Measurand:

Factor II Prothrombin and Factor V Leiden genes in human blood specimens

D. Type of Test: DNA Genotyping test
E. Applicant:

Illumina, Inc.

F. Proprietary and Established Names: Illumina VeraCode® Genotyping Test for Factor V and Factor II

G. Regulatory Information:

1. Regulation section:
  21 CFR 864.7280; Factor V Leiden DNA mutation detection systems
Classification: 2.
Class II
1. Product code:

NPR; Test, Factor II G20210A Mutations, Genomic DNA PCR NPO: Test, Factor V Leiden Mutations, Genomic DNA PCR

1. Panel:
  Hematology (81)

H. Intended Use: 1. Intended use(s):

1. Indication(s) for use: Same as Intended Use.
1. Special conditions for use statement(s): Prescription use only.
Special instrument requirements: 4. BeadXpress® System (K093128), VeraScan software v. 2.0.17

I. Device Description:

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reagent (1 x 4.8 mL) and Fast Start Taq DNA Polymerase (1 x 60 µL), VW2 buffer (1 x 60 mL), a VeraCode FV/FII Bead Plate with holographically inscribed glass microbeads aliquoted in strip-well plates, a test-specific kit manifest file and sample sheet files (containing test specific outcome specifications and sample plate layout files used to interpret and report genotype results). A magnet plate is also required but sold separately.

J. Substantial Equivalence Information:

1. Predicate device name(s):
- AutoGenomics INFINITI System for Factor II and Factor V
1. Predicate K number(s): K060564
1. Comparison with predicate:

Similarities
Item	Device	Predicate
Intended Use/Indications for Use	The VeraCode Genotyping Test for Factor V and Factor II is an in vitro diagnostic for the detection and genotyping of Factor V Leiden G1691A and Factor II (Prothrombin) G20210A point mutations in DNA obtained from EDTA anti-coagulated human blood samples. The test is intended for use on the BeadXpress System. The VeraCode Genotyping Test for Factor V and Factor II on the BeadXpress System is indicated for use as an aid to diagnosis in the evaluation of patients with suspected thrombophilia.	Same
Specimen type	Genomic DNA (gDNA) isolated from EDTA human whole blood	Same
Sample preparation	DNA extraction and purification performed off-line.	Same
Reference method	Bi-directional sequencing	Same
No. of mutations/variants detected	2, Factor II (Prothrombin) G20210A and Factor V Leiden G1691A	Same
Assay result output	Assay results interpreted by a software program and assigned a genotype presented to the end user in a report format	Same
	Illumina VeraCode® Genotyping Testfor Factor V and Factor II	AutoGenomicsINFINITI Systemfor Factor II andFactor V

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Differences
Item	Device	Predicate
Instrumentation	BeadXpress® System andVeraScan software v. 2.0.17	INFINITI System
Technology	Microbead array	Biofilm chip microarray
Detection Chemistry	Isolation of DNA from humanblood sample, allele-specificprimer extension and ligation,PCR amplification of theligated primers, hybridizationof the amplified product, andsignal detection usingfluorescence	Isolation of DNA fromhuman blood sample, PCRamplification of thepurified DNA, allele-specific primer extension,hybridization of theextended product, andsignal detection usingfluorescence
Input gDNA amount	2 µL (25 ng/µL)	5 µL (5-100 ng/µL)

K. Standard/Guidance Document Referenced (if applicable):

CLSI EP5-A2, Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline - Second Edition
CLSI EP7-A, Interference Testing in Clinical Chemistry; Approved Guideline 2nd Edition
CLSI EP17-A, Protocols for Determination of Limits of Detection and Limits of Quantitation
FDA Class II Special Controls Guidance, Factor V Leiden DNA Mutation Detection Systems

L. Test Principle:

The VeraCode Genotyping Test for Factor V and Factor II kit is an in vitro diagnostic device for mutation detection and genotyping of two mutations in two different genes related to increased risk for deep vein thrombosis, Factor V Leiden G1691A and Factor II (Prothrombin) G20210A point mutations in DNA obtained from EDTAanticoagulated human blood. The VeraCode Genotyping Test for Factor V and Factor II utilizes polymerase chain reaction (PCR) primers, hybridization matrices, controls, holographically inscribed glass microbeads (VeraCode Microbead Plates) and assay-specific kit manifest files supplied with the reagent kit. The kit is run with processing reagents, general laboratory instrumentation and the Illumina BeadXpress Svstem.

Genomic DNA is extracted from EDTA-anticoagulated whole blood. The assay uses allele-specific primer extension and ligation to detect sequence variants, followed by PCR amplification with fluorescent primers, hybridization to VeraCode beads, and collection of fluorescence data using the BeadXpress Reader.

The VeraCode Microbead Plates are assay specific, with each distinct holographic digitally coded microbead coated with a capture molecule. The BeadXpress® System is a fluidic microbead reader with VeraScan software for detection and genotyping multiple genes in a purified DNA sample. The BeadXpress includes a dual-color

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laser detection system that enables optical scanning of multiplexed assays developed using the VeraCode digital microbead technology and VeraScan software.

The BeadXpress System includes red and green lasers for detecting and recording information from individual VeraCode assays (VeraCode Microbead Plates) loaded onto the BeadXpress Reader tray. After test samples are captured by the microbeads, fluorescently labeled reporter molecules complete the reaction. The BeadXpress Reader uses fluidics to collect and array the microbeads. The beads are scanned for their code and fluorescent signals, generating data as binary files, which are then used in downstream analysis with the assay-specific kit manifest files. The assay-specific kit manifest contains the parameters and cutoffs used to produce and report a genotype result.

M. Performance Characteristics (if/when applicable):

Analytical performance: 1.
- a. Precision/Reproducibility:

A panel of 15 genomic DNA samples isolated from blood and consisting of 3 independent samples for each of the 5 possible genotypes (including Wild Type), were distributed to each of the three sites. At each site, two operators tested each sample in duplicate once a day for 5 non-consecutive days. Samples yielding invalid results were retested once and no incorrect calls were observed when the results were compared to bi-directional sequencing. Overall summary data based on the number of calls are shown below in Table 1 and 2. Summary data by operator and by site are shown in Tables 3 and 4.

		No. of sample						No. of FV Calls Before Repeat
		replicates			Testing					No. of FV Calls After Repeat Testing
					Correct calls			%		# repeated*		Correct calls				%
Genotype by								Site Site Site Site # No Agree- 95% Site Site Site Site Site Site Site Site Site Site Site Site Site Site Site Site Site Site									No Agree-	તેરજ
sequencing		1 2	ന്നും നിന്നും അവലംബം പ്രത്യേക്കുന്നു. അവലംബം അവലംബം അവലംബം അവലംബം അവലംബം അവലംബം അവലംബം അവലംബം അവലംബം	11 -	റ്റ് 2 പ		3 Calls*	ment LCB3		-	12 "	3	-	2	3		calls ment	LCB
Wild Type					160 160 160 155 160 157		8	98.3 97.0		ત્ત્વની સાથે અને અને અને અને અને અને અને અને અને અને અને અને અને અને અને અને અને અને અને અને અને અને અને અને અને અને અને અને અને અને અને અને અને અને અને અને અને અને અને અને	! ()					0	100	99.38
Heterozygous	80	80	80	79	. 78	80	3	98.8 96.8			2 '	0	80	79	80		99.58 98.04
Homozygous	60	(୧୦	60	રેક	28	60	4	97.8	97.8	2	" 2 "	0	60	60	60	0	100	98.35

Table 1. Summary of Reproducibility Study - Factor V

Table 2. Summary of Reproducibility Study - Factor II

Genotype bysequencing	No. of sample replicates			No. of FII Calls Before RepeatTesting						No. of FII Calls After Repeat Testing
	Site 1	Site 2	Site 3	Correct calls			# NoCalls¹	%Agreement	95%LCB³	# repeated⁴			Correct calls			Nocalls	%Agreement	95%LCB
Wild Type	180	180	180	177	179	178	6	98.9	97.8	3	1	2	180	180	180	0	100	99.45
Heterozygous	60	60	60	59	60	60	1	99.4	97.4	1	0	0	60	60	60	0	100	98.35
Homozygous	60	60	60	57	59	59	5	97.2	94.3	3	1	1	60	60	60	0	100	98.35

1 Sample failures or results generating a "no call" result and require repeating.

2 Missed calls = wrong or incorrect calls

3 One-sided 95% lower confidence bound

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	Site 1		Site 2		Site 3		%Agreement
	Op 1	Op 2	Op 1	Op 2	Op 1	Op 2
WT	100%(80/80)	100%(80/80)	100%(80/80)	100%(80/80)	100%(80/80)	100%(80/80)	100%(480/480)
HET	100%(40/40)	100%(40/40)	97.5%(39/40)	100%(40/40)	100%(40/40)	100%(40/40)	99.6%(239/240)
VAR	100%(30/30)	100%(30/30)	100%(30/30)	100%(30/30)	100%(30/30)	100%(30/30)	100%(180/180)
No-Call*(1st pass)	4	4	4	0	2	1	15
No-Callafter retest	0	0	1	0	0	0	1

Table 3. Summary of Reproducibility Result by Operator - Factor V

resolved upon retest

Table 4. Summary of Reproducibility Result by Operator - Factor II

	Site 1		Site 2		Site 3		%
	Op 1	Op 2	Op 1	Op 2	Op 1	Op 2	Agreement
WT	100%(90/90)	100%(90/90)	100%(90/90)	100%(90/90)	100%(90/90)	100%(90/90)	100%(540/540)
HET	100%(30/30)	100%(30/30)	100%(30/30)	100%(30/30)	100%(30/30)	100%(30/30)	100%(180/180)
VAR	100%(30/30)	100%(30/30)	100%(30/30)	100%(30/30)	100%(30/30)	100%(30/30)	100%(180/180)
No-Call*(1st pass)	4	3	2	0	2	1	12

resolved upon retest

Lot-to-Lot Reproducibility:

Three kit lots were tested by running five partial plates on a single BeadXpress Reader by a single operator over the course of five nonconsecutive days. Six gDNA samples from commercially available cultured cells were used to represent each possible genotype, including a compound heterozygous sample and each was represented 5 times (replicates) in each run, at or near 25 ng input. Two no template controls (NTCs) were also represented in each run. Genotypes were determined by the VeraScan software and Factor V & Factor II Kit manifest file. No-template controls (NTCs) were considered valid if signals for all functional loci were below threshold. An invalid NTC counts against Call Rate but not against Correct Call Rate. Call Rate and Correct Call Rate were calculated for each run and for each kit lot by pooling the data from the five runs. No sample failures resulting in an invalid result were noted for two of the three lots and one sample of the third lot generated an invalid (no call) result.

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b. Linearity/assay reportable range: Not applicable.
Traceability, Stability, Expected values (controls, calibrators, or methods): C. The reference method is bi-directional sequencing.

Shelf life stability:

Summary stability information for an initial one month shelf life was provided, however real-time stability studies are still on-going.

Shipping stability:

Shipping stability was simulated by exposing three separate lots to cycling temperatures for specified durations from 22°C (4 hr.), 35°C (2 hr.), 30°C (36 hr.), and 35°C (22 hr.) to simulate 48 hour domestic shipping in the summer. Upon completion of temperature cycling, each kit was placed in dry ice and then functionally tested. Kits 1 and 3 each had one sample give an invalid result.

Carryover:

DNA samples were distributed across the reaction plate such that high concentrations of Factor V and Factor II heterozygote or homozygote variant samples were alternated with low concentrations of wild type or negative control samples in a checkerboard pattern. High concentrations of gDNA consisted of 500 ng input and low concentrations consisted of 25 ng input gDNA. All DNA samples genotyped correctly and there was no evidence of carryover from high concentration samples into low concentration samples. Three of the 24 NTC samples gave a signal over the acceptable threshold, however an investigation of the signals for each of the mutations showed that the only potential source for the contamination was several columns away with low concentration and other NTCs in between or were from wells after the affected wells which does not support potential carryover in two of the three cases. Three additional studies were performed but the original observations were not reproduced and the initial failures were not indicative system performance with respect to carryover.

d. Detection limit:
Analytical sensitivity for this test was defined as the lower limit of DNA input needed to generate a valid genotyping result. To establish a preliminary range of acceptable DNA input, a series of experiments was performed using Factor V and Factor II wild type, heterozygous and homozygous variant gDNA samples obtained from commercially available cell lines. DNA samples were suspended in TE buffer, such that the DNA input ranged from 1 – 1,000 ng per sample. Five replicates of each sample were run per plate and DNA input levels of 5 ng, 10 ng, 25 ng, 500 ng, and 1000 ng met the preliminary passing criteria where all replicates of all genotypes produce the correct result when compared to bi-directional sequencing. Twenty-five (25) and 500 ng were selected as the preliminary DNA input claim based on having a lower (10 ng) and a higher (1000 ng) input, respectively, that passed the preliminary passing criteria. To allow for sample failures unrelated to DNA input, one invalid

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sample per run was allowed and one sample with a failed hybridization control was allowed. A preliminary range for a DNA input claim was established with a "low" and a "high" DNA input. The DNA input limits of 25 ng (5 ng/uL) and 500 ng (100 ng/uL) were tested with another two reagent kit lots and one additional VeraCode Bead Plate Factor V/Factor II lot and all replicates were successfully genotyped.

e. Analytical specificity:
To determine the potential effect of heparin on test results as interference may be observed from patients on heparin therapy, a concentrated solution of sodium heparin was spiked directly into prospectively drawn blood samples, as recommended in CLSI EP7-A2, at 100 U/dL, 300 U/dL, and 900 U/dL. High levels of heparin added to whole blood did not adversely affect assay performance on the resulting extracted DNA.

To rule out any potential interference by endogenous interfering substances (i.e., bilirubin, hemoglobin, and cholesterol) each was spiked into aliquots from two EDTA-anticoagulated blood samples (1 FV HET and 1 FII HET) to a final concentration, at or above those recommended in Appendix D of CLSI EP7-A2. at 684 umol/L (bilirubin), 13 mmol/L (cholesterol), and 2 g/L (hemoglobin). Each spiked aliquot was tested with the VeraCode Bead Plate Factor V/Factor II and compared to an aliquot spiked with the individual carrier used to dilute the interferent. All samples genotyped equivalently across the entire experiment and no assay failures were observed in the external positive control samples or the samples extracted from blood spiked with potential interfering substances or vehicle only. Therefore elevated levels (as defined by CLSI guideline EP7-A2) of bilirubin, cholesterol, hemoglobin, and heparin in blood do not adversely influence the performance of the VeraCode Genotyping Test for Factor V and Factor II. The claimed genotypes for these DNA samples were confirmed by bidirectional sequencing.

f. Assay cut-off: Not applicable.

2. Comparison studies:

a. Method comparison with predicate device:
Accuracy was measured as overall percent agreement of the genotyping results produced by the VeraCode Genotyping Test for Factor V and Factor II as compared to those resulting from bi-directional DNA sequencing. Ninety-two patient samples were accrued at each of the three sites, yielding a total of 276 patient samples, from pre-selected or unscreened patients undergoing Factor V testing and each site was provided with two archived DNA samples to serve as positive controls. The samples were then analyzed using the VeraCode and compared to bi-directional sequencing analysis performed at an independent reference laboratory. All genomic DNA samples were extracted from EDTA anti-coagulated whole blood samples. A summary of the make up of samples by site and summary results are shown in Tables 5-7 below.

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	Site 1	Site 2	Site 3
WT (for FV)	72	78	63
WT (for FII)	83	85	77
FVL Heterozygous	17	11	21
FVL Homozygous	3	3	8
FII Heterozygous	7	5	12
FII Homozygous	2	2	3

Table 5. Summary of samples genotypes by site.

Table 6. Summary Method Comparison – Factor V

		Number of FVL Calls Before Repeat Testing					Number of FVL Calls After Repeat Testing
Genotype bysequencing	#samples	Correctcalls	# NoCalls1	MissedCalls2	%Agreement	95%LCB3	Correctcalls	# NoCalls1	MissedCalls2	#Repeatedsamples4	%Agreement	95%LCB3
Wild Type	213	213	0	0	100	89.6	213	0	0	0	100	98.6
Heterozygous	49	46	3	0	93.88	84.93	49	0	0	3	100	94.07
Homozygous	14	13	1	0	92.86	70.33	13	1	0	1	92.86	70.33

Table 7. Summary Method Comparison - Factor II.

		Number of FII Calls Before Repeat Testing					Number of FII Calls After Repeat Testing
									Misse	#
Genotype by	#	Correct	# No	Missed	%	વેરી જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામનાં લોકોનો મુખ્ય વ્યવસાય ખેતી, ખેતમજૂરી તેમ જ પશુપાલન છે. આ ગામમાં મુખ્યત્વે ખેત-ઉત્પાદની તેમ જ દૂધની ડેરી જેવી સવલતો પ્રાપ્ય થયેલી છે	Correct # No		in de co	Repeated	%	વેરી જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામમાં પ્રાથમિક શાળા, પંચાયતઘર, આંગણવાડી તેમ જ દૂધની ડેરી જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામમાં પ્રાથમિક શાળા, પંચાયતઘર, આંગણવાડી તેમ જ દ
sequencing	samples	. calls ! ?	Calls	Calls-	Agreement LCB3		calls				Calls Calls = samples Agreement LCB3
Wild Type	245	244		0	ਰੇਰੇ 'ਤੇਰੇ	98.08	244		()		તેત્વે તે તે તે તે તે તે તે તે તે તે તે તે તે આ ગામમાં પ્રાથમિક શાળા, પંચાયતઘર, આંગણવાડી તેમ જ દૂધની ડેરી જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામનાં પ્રાથમિક શાળા, પંચાયતઘર, આંગણ	98.08
Heterozygous	24	23		0	95.83	81.71	24	0	0		100	88.27
Homozygous	l	7	0	0	100	65.18	7	0	0	0	100	65.18

1 Sample failures or results generating a "no call" result and require repeating.

2 Missed calls = wrong or incorrect calls

3 One-sided 95% lower confidence bound

b. Matrix comparison:

Not applicable. Both assays use gDNA purified from EDTA anti-coagulated whole blood

1. Clinical studies:
- Clinical Sensitivity: a. Not applicable.
- b. Clinical specificity: Not applicable.
- c. Other clinical supportive data (when a. and b. are not applicable): Not applicable.
1. Clinical cut-off:

Not applicable.

ನ. Expected values/Reference range: Not applicable. Factor II (G20210A) and Factor V Leiden (G1691A) mutations are present in 2% and 5% of the general population, respectively.

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N. Proposed Labeling:

The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.

O. Conclusion:

The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

Regulation Number and Section

§ 864.7280 Factor V Leiden DNA mutation detection systems.

(a)
Identification. Factor V Leiden deoxyribonucleic acid (DNA) mutation detection systems are devices that consist of different reagents and instruments which include polymerase chain reaction (PCR) primers, hybridization matrices, thermal cyclers, imagers, and software packages. The detection of the Factor V Leiden mutation aids in the diagnosis of patients with suspected thrombophilia.(b)
Classification. Class II (special controls). The special control is FDA's guidance entitled “Class II Special Controls Guidance Document: Factor V Leiden DNA Mutation Detection Systems.” (See § 864.1(d) for the availability of this guidance document.)