The illumigene C. difficile DNA amplification assay, performed on the illumipro-10, is a qualitative in vitro diagnostic test for the direct detection of toxigenic C. difficile in human stool specimens from pediatric and adult patients suspected of having Clostridium difficile-associated disease (CDAD).

The illumigene C. difficile assay utilizes loop-mediated isothermal DNA amplification (LAMP) technology to detect the pathogenicity locus (PaLoc) of toxigenic Clostridium difficile PaLoc is a gene segment present in all known toxigenic C. difficile strains. The C. difficile PaLoc codes for both the Toxin A gene (tcdA) and the Toxin B gene (tcdB), has conserved border regions, and is found at the same site on the C. difficile genome for all toxigenic strains. The illumigene C. difficile assay detects the Paloc by targeting a partial DNA fragment on the Toxin A gene. The tcdA target region was selected as an intact region remaining in all known A+B+ and A-B+ toxinotypes.

illumigene C. difficile is intended for use in hospital, reference or state laboratory settings. The device is not intended for point-of-care use.

Device Description

The illumigene Molecular Diagnostic Test System is comprised of the illumigene C. difficile DNA Amplification Test Kit, the illumigene C. difficile External Control Kit and the illumipro-10 Automated Isothermal Amplification and Detection System. The illumigene C. difficile DNA amplification assay utilizes loop-mediated isothermal amolification (LAMP) technology to detect the presence of toxigenic C. difficile in patients suspected of having C. difficile associated disease (CDAD). Each illumigene C. difficile assay is completed using an illumigene Sample Preparation Apparatus. Illumigene Reaction Buffer, illumigene C. difficile Test Device, Sample Collection Brush, and illumigene Extraction Tube. Samples are prepared using the Sample Collection Brush and the illumigene Sample Collection Apparatus, target DNA is heat extracted in the Extraction Tube and DNA amplification occurs in the illumigene C. difficile Test Device.

The illumipro-10 heats each illumigene C. difficile Test Device containing prepared samples, facilitation of target DNA. When toxigenic C. difficile is present in the patient specific sequence is amplified and Magnesium pyrophosphate is formed. Magnesium pyrophosphate in the reaction mixture. The illumipro-10 detects the change in light transmission mixture created by the precipitating Magnesium pyrophosphate. Sample results are reported as Positive based on the detected change in transmission.

The illumigene C. difficile External Control Kit consists of a Positive Control Reagent. External Control reagents are provided to aid the user in detection of reagent deterioration, adverse environmental or test conditions, or variance in operator performance that may lead to test errors. The illumigene C. difficile External Control Kit is required for routine Quality Control.

AI/ML Overview

The illumigene C. difficile DNA amplification assay is a qualitative in vitro diagnostic test for the direct detection of toxigenic C. difficile in human stool specimens from pediatric and adult patients suspected of having Clostridium difficile-associated disease (CDAD). The assay detects a partial DNA fragment on the Toxin A gene within the pathogenicity locus (PaLoc) of toxigenic C. difficile.

1. Table of acceptance criteria and reported device performance:

The document does not explicitly state pre-defined acceptance criteria values for sensitivity and specificity. However, based on the presented clinical trial results, the observed performance metrics can be considered the demonstrated performance of the device.

Performance Metric	Acceptance Criteria (Implicit from reference K100818)	Reported Device Performance (Patients ≥ 2 years)	Reported Device Performance (Patients < 2 years)
Sensitivity	Not explicitly stated (predicate device performance)	95.2% (95% CI: 89.2% - 97.9%)	93.3% (95% CI: 78.7% - 98.2%)
Specificity	Not explicitly stated (predicate device performance)	95.3% (95% CI: 93.2% - 96.7%)	96.3% (95% CI: 92.2% - 98.3%)
Invalid Rate	Not explicitly stated	2.9% (20/697)	0.5% (1/193)

2. Sample size used for the test set and the data provenance:

Patients ≥ 2 years of age: 697 qualified patient samples.
Patients < 2 years of age: 193 qualified patient samples.
Data Provenance: The samples were collected from independent clinical test sites located in the Midwestern and Southern regions of the United States, and from the manufacturer. This indicates prospective clinical studies conducted in the US.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

The ground truth was established by cytotoxic bacterial culture. This is a laboratory-based method and does not involve human expert interpretation in the same way as, for example, a radiologist reading an image. Therefore, the concept of "number of experts" or their specific qualifications (e.g., years of experience for image interpretation) is not directly applicable here. The validity of the cytotoxic bacterial culture would rely on standard laboratory protocols and accredited personnel.

4. Adjudication method for the test set:

Not explicitly mentioned for the comparison to cytotoxic bacterial culture. However, for discordant results (false positives/negatives), another FDA cleared molecular assay for C. difficile detection or for detection of GDH (Glutamate Dehydrogenase) was used for further investigation. This suggests a form of secondary assessment or confirmation for discrepant results, but not an "adjudication method" in the typical sense of expert consensus on initial interpretations.

5. 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:

This is a diagnostic device for molecular detection, not an imaging device requiring human reader interpretation in the context of an MRMC study. Therefore, an MRMC comparative effectiveness study was not applicable and not performed. The device provides a direct positive/negative result.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Yes, the device was evaluated in a standalone manner. The "illumigene C. difficile DNA amplification assay, performed on the illumipro-10" directly provides results as "Positive" or "Negative" based on detected changes in light transmission, without human interpretation of the assay's primary output. Human involvement is in sample preparation and loading, and interpreting the final reported result from the instrument.

7. The type of ground truth used:

The ground truth used was cytotoxic bacterial culture.

8. The sample size for the training set:

The document does not explicitly state a separate "training set" for the clinical performance evaluation. The clinical trials (697 patients ≥ 2 years and 193 patients < 2 years) appear to represent the primary evaluation/test sets against the established ground truth. For analytical sensitivity and reproducibility, specific dilutions and contrived samples were used, which are more akin to analytical validation rather than a clinical training set.

9. How the ground truth for the training set was established:

As no explicit "training set" for clinical performance was described in the same way as the test set, the method for establishing ground truth for a training set is not detailed. However, if any development work involved culture-confirmed samples, the ground truth would have been established by similar laboratory methods like cytotoxic bacterial culture or culture confirmed C. difficile strains (e.g., for analytical sensitivity). For the analytical studies, "natural negative" and "contrived positive" samples were prepared, with the "natural negative" samples confirmed by cytotoxic bacterial culture.

Summary

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Image: Meridian Bioscience, Inc. logo	Special 510(k) Application illumigene C. difficile, Performance Characteristic Extension
	Description:	510(k) Summary illumigene C. difficile
	Identification:	Attachment 002
	Date:	December 31, 2010

510(k) number:	K110012	Date of preparation:	December 31, 2010
Submitter:	Meridian Bioscience, Inc.
Submitter's address:	3471 River Hills Drive
	Cincinnati, Ohio 45244
Contact:	Michelle Smith
Contact number:	(513) 271-3700
Device name:	illumigene® C. difficile
Common name:	C. difficile DNA Amplification Assay
Classification name:	C. difficile Nucleic Acids
	OMN, CFR Section 866.2660
Predicate device:	K100818: illumigene® Molecular Diagnostic Test System (illumigene C. difficile DNA Amplification Assay, illumipro-10)
	Model 280050, 610172
Reference comparator:	Cytotoxic bacterial culture

FEB 2 4 2011# Description of the device:

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Image: Meridian Bioscience, Inc. logo	Special 510(k) Application illumigene C. difficile, Performance Characteristic Extension
	Description:	510(k) Summary illumigene C. difficile
	Identification:	Attachment 002
	Date:	December 31, 2010

Intended Use:

The illumigene C. difficile assay utilizes loop-mediated isothermal DNA amplification (LAMP) technology to detect the pathogenicity locus (PaLoc) of toxigenic Clostridium difficile Paloc is a gene segment present in all known toxigenic C. difficile strains. The C. difficile Paloc codes for both the Toxin A gene (tcdA) and the Toxin B gene (tcdB), has conserved border regions, and is found at the same site on the C. difficile genome for all toxigenic strains. The illumigene C. difficile assay detects the Paloc by targeting a partial DNA fragment on the Toxin A gene. The tcdA target region was selected as an intact region remaining in all known A+B+ and A-B+ toxinotypes.

illumigene C. difficile is intended for use in hospital, reference or state laboratory settings. The device is not intended for point-of-care use.

Characteristic	illumigene™ C. difficile, Revised	illumigene™ C. difficile, K100818
Test Format	No Change	DNA Amplification Assay
Intended Use
DNA Amplification Technology	No Change	Loop-Mediated Isothermal Amplification (LAMP)
Target Sequences Detected	No Change	Partial DNA fragment on the Toxin A gene of thepathogenicity locus (PaLoc) found in all knownstrains for toxigenic C. difficile.
Qualitative/Quantitative	No Change	Qualitative
Screening, Diagnostic orIdentification Test	No Change	Diagnostic
Specimen Types
Unformed Human Stool	No Change	Yes
Human Stool in Cary-Blair-basedMedia	No Change	Yes
Reagents/Components	illumigene Sample Preparation Apparatusillumigene Reaction Bufferillumigene C. difficile Assay Deviceillumigene Heat Treatment TubesSample Collection Brushes	illumigene Sample Preparation Apparatusillumigene Reaction Bufferillumigene C. difficile Assay Deviceillumigene Extraction TubesSample Collection Brushes
Extraction	Not Applicable.Sample preparation by heat treatment. DNAExtraction and purification not required.	Manual
Amplification	No Change	Self-contained and automated

Comparison to predicated device:

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Specimen	Special 510(k) Application illumigene C. difficile, Performance Characteristic Extension
Description	Description:	510(k) Summary illumigene C. difficile
Identification	Identification:	Attachment 002
Date	Date:	December 31, 2010

Comparison to predicated device:

Characteristic	illumigene™ C. difficile, Revised	illumigene™ C. difficile
Detection	No Change	Self-contained and automated
Testing Time	No Change	Approximately 60 minutes
Calibration	No Change	Not required
Controls
Inhibition, Assay	No Change	Providedillumigene Sample Preparation Apparatus:Staphylococcus aureusillumigene C. difficile Assay Device: Staphylococcus aureus LAMP PrimersAdjunct Reagentsilllumigene C. difficile External Control KitCatalog 279920
External	No Change	illlumigene C. difficile External Control KitCatalog 279920
Extraction	Not Applicable.Sample preparation, including heat treatment monitored by external thermometer and interval timer. Equipment is user supplied.	User Supplied
Equipment
Instrumentation	No Change	illumipro-10™ Automated Isothermal Amplification and Detection System
	Micropipette 50 µL, 200 µL	Micropipette 50 µL, 200 µL
	Dry-bath with 12mm Heat Block, 95 C	Dry-bath with 12mm Heat Block, 95 C
	Interval Timer	Interval Timer
General Laboratory Equipment	Vortex Mixer	Vortex Mixer
	Digital Thermometer with Max/MinTemperature Memory
Reading Method	No Change	Visible Light Transmission
Results
C. difficile Toxinotypes Tested	No Change	0 (A+/B+)III (A+/B+)V (A+/B+)VIII (A-/B+)X (A-/B+)XII (A+/B+)IX/XXIII (A+/B+)INVALIDPOSITIVENEGATIVE
Results Interpretation	No Change

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MeridianBioscience, Inc.	Special 510(k) Application illumigene C. difficile, Performance Characteristic Extension
Description:	510(k) Summary illumigene C. difficile
Identification:	Attachment 002
Date:	December 31, 2010

Performance Comparison, Non-clinical Tests: Interference Testing (Reference K100818)

Selected drugs and other non-microbial substances that might be present in stool samples from heathly persons or patients suspected of having C. difficile associated disease were added to a natural negative and a contrived positive sample. The natural negative and contrived positive samples were prepared from donor samples and were confirmed negative by cytotoxic bacterial culture. The contrived positive sample was prepared by spiking a confirmed negative sample with toxinogenic C. difficile strain VPI 10463 to 18 CFU/test, slightly above the 16 CFU assay limit of detection for this organism. Potentially interfering substances were added at final concentrations of 5% V/V or greater. Dilution Controls for each sample were prepared by adding a phosphatebuffered saline solution in place of the potentially interfering substance. Each sample was tested in triplicate.

The following substances, at the specified saturated solvent/diluents concentrations, do not interfere with illumigene C. difficile test results in the final concentrations listed: Barium sulfate (5 mg/ml), fecal fat (equivalent to 2.65 mg palmitic acids per mL), hemoglobin (as methemoglobin) (3.2 mg/mL), Imodium AD® (0.00667 mg/mL), Kaopectate® (0.87 mg/mL), Metronidazole (12.5 mg/ml, mucin (3.33 mg/mL), Pepto-Bismol® (0.87 mg/mL), Prilosec® (0.5 mg/mL), Tagamet® (0.5 mg/mL), TUMS® (0.5 mg/mL), Vancomycin (12.5 mg/mL), white blood cells (5%V/V), whole blood (5% V/V).

Cross-reactivity Study (Reference K100818)

Potentially cross-reactive microorganisms that might be present in stool samples from healthy suspected of having C. difficile associated disease were added to a natural negative and a contrived positive sample. The natural negative and contrived positive samples were prepared from donor samples and were confirmed negative by cytore. The contrived positive sample was prepared by spiking a confirmed negative sample with toxinogenic C. difficile strain VPI 10463 to 18 CFU/test, slightly above the 16 CFU assay limit of detection for this organism. Potentially cross-reactive microorganisms were added at concentrations of 1.2 x 10 / ml (bacteria and fungi) or 1 x 10 / 9 / ml (viruses). Dilution Controls for each sample were prepared by adding a phosphate-buffered saline solution in place of the potentially cross-reactive microorganisms. Each sample was tested in triplicate.

The following microorganisms, at the indicated concentrations, do not interfere with illumigene C. difficile test results:

Aeromonas hydrophila, Bacteroides fragilis, Campylobacter fetus, Campylobacter jejuni, Candida albicans, Citrobacter frendii, Clostridium perfringens, Enterobacter cloace, Enterococcus faeadis, Escherichia coli, Escherichia coli 0157:H7, Escherichia hermannii, Helicobacter pylori, Klebsiella pneumoniae, Lactococcus lactis, Listeria monocytogenes, Peptostreptococus anaerobius, Plesiomonas shigelloides, Proteus vulganoso, Pseudomonas fluorescens, Salmonella Groups B-E, Serratia marcescens, Shigella boydi, Shigella flexneri, Shigella sonnei, Staphylococus aureus, Staphylococus epidermidis, Yersinia enterocolitica, Adenovirus Types 40 and 41, Coxsackievirus, Echovirus, Rotavirus.

Performance Comparison, Clinical Tests:

Clinical trials for the illumigene C. difficile assay, including the illumipro-10 Automated Isothermal amplification and detection system, were conducted in 2010. Performance characteristics of the illumigene C. difficile assay were determined by comparison to cytotoxic bacterial culture in two separate studies: (1) Patients 2 years of age and above and (2) Patients less than 2 years of age.

(1) Patients 2 years of age and above: Independent clinical test sites located in the Midwestern and Southern regions of the United States and the manufacturer evaluated a total of 697 qualified patient samples were collected from 274 (39.3%) males and 419 (60.1%) females. In the case of 4 (0.6%) of the patients, sex was not known. The age groups of patients range from 2 years of age to 96 years. No differences in test performance were observed based on patient age, gender or geographical location. Overall Sensitivity was determined to be 95.2% (95% Cl: 89.2% - 97.9%). Overall Specificity was determined to be 95.3% (95% Cr: 93.2% -96.7%). Subsequent tables show overall assay performance by clinical site and patient age.

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	Special 510(k) Application illumigene C. difficile, Performance Characteristic Extension
	Description:	510(k) Summary illumigene C. difficile
	Identification:	Attachment 002
	Date:	December 31, 2010

Table 1. Performance data (Patients 2 years of age and above)

Cytotoxic bacterialculture	illumigene C. difficile
	Positive	Negative	Invalid***	Total
Positive	99	5**	4	108
Negative	27*	546	16	589
Total	126	551	20	697
			95% CI
Sensitivity	99/104	95.2%	89.2 - 97.9%
Specificity	546/573	95.3%	93.2 - 96.7%
Correlation	645/677	95.3%	93.4 - 96.6%
Invalid Rate	20/697	2.9%		N/A

15/27 false positive results were positive by another FDA cleared molecular assay. Of the remaining 12 false positive by a FDA cleared assay for the detection of GDH.

- 2/5 false negative results were negative by another FDA cleared molecular assay,

*** Invalid results were obtained for 20/697 (2.9%) samples tested. Eleven (1.6%) of the invalids observed were categorized as Assay Invalids, indicative of improper sample preparation, reagent failure, instrument failure. One of the eleven specimens remained invalid after repeat testing from the original sample.

Site	Positive Samples			Negative Samples
	illumigene/Cytotoxicbacterialculture	Sensitivity %	95% CI	illumigene/Cytotoxicbacterialculture	Specificity %	95% CI
Total	99/104	95.2%	89.2 – 97.9%	546/573	95.3%	93.2 – 96.7%
Site 1	4/5	80.0%	37.6 – 96.4%	58/60	97.6%	88.6 – 99.1%
Site 2	12/12	100%	75.7 – 100%	62/67	92.5%	83.7 – 96.8%
Site 3	20/20	100%	83.9 – 100%	87/92	94.6%	87.9 – 97.7%
Site 4	8/8	100%	67.6 – 100%	36/39	92.3%	79.7 – 97.3%
Site 5	55/59	93.2%	83.8 – 97.3%	303/315	96.2%	93.5 – 97.8%

(2) Patients less than 2 years of age: Independent clinical test sites located in the Midwestern and Southern regions of the United States and the manufacturer evaluated a total of 193 qualified patient samples were collected from 103 (53.4%) males and 90 (46.6%) females. The age groups of patients tested ranged from 0 months. No differences in test performance were observed based on patient age, gender or geographical location. Overall Sensitivity was determined to be 93.3% (95% Cl. 78.7 -98.2%). Overall Specificity was determined to be 96.3% (95% Cl: 92.2% - 98.3%). Subsequent tables show overall assay performance as well as performance by clinical site and patient age.

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Image: Meridian Bioscience, Inc. logo	Special 510(k) Application illumigene C. difficile, Performance Characteristic Extension
	Description:	510(k) Summary illumigene C. difficile
	Identification:	Attachment 002
	Date:	December 31, 2010

Table 3. Performance data (Patients less than 2 years of age)

Cytotoxic bacterialculture	illumigene C. difficile
	Positive	Negative	Invalid***	Total
Positive	28	2**	1	31
Negative	6*	156	0	162
Total	34	158	1	193
			95% CI
Sensitivity	28/30	93.3%	78.7 - 98.2%
Specificity	156/162	96.3%	92.2 - 98.3%
Correlation	184/192	95.8%	92.0 - 97.9%
Invalid Rate	1/193	0.5%	N/A

3/6 false positive results were positive by another assay. Of the remaining 3 false positive results, all were positive by a FDA cleared assay for the detection of GDH.

** 1/2 false negative results were negative by another FDA cleared molecular assay.

*** Invalid results were obtained for 1/193 (0.5%) samples tested. The invalid observed was an Assy Invalid, indicative of improper sample preparation, reagent failure, instrument failure. The specimen remained invalid after repeat testing from the original sample,

Table 4. Performance characteristics by site (Patients less than 2 years of age)

Positive Samples			Negative Samples
Site	illumigene /Cytotoxicbacterialculture	Sensitivity %	95% CI	illumigene /Cytotoxicbacterialculture	Specificity %	95% CI
Total	28/30	93.3%	78.7 - 98.2%	156/162	96.3%	92.2 - 98.3%
Site 1	8/8	100%	67.6 - 100%	48/49	98.0%	89.3 - 99.6%
Site 2	20/22	90.9%	72.2 - 97.5%	105/109	96.3%	90.9 - 98.6%
Site 4	0/0	N/A	N/A	2/3	66.7%	20.8 - 93.9%
Site 5	0/0	N/A	N/A	1/1	100%	20.7 - 100%

Table 5. Overall results by patient age

	Positive Samples			Negative Samples
Patient age	illumigene /Toxigenicculture	Sensitivity %	95% CI	illumigene /Toxigenicculture	Specificity %	95% CI
< 2 years	28/30	93.3%	78.7 - 98.2%	156/162	96.3%	92.2 - 98.3%
≥ 2 to 12 years	10/11	90.9%	62.3 - 98.4%	75/79	94.9%	87.7 - 98.0%
> 12 to 21 years	5/5	100%	56.6 - 100%	53/56	94.6%	85.4 - 98.2%
> 21 years	83/87	95.4%	88.8 - 98.2%	417/437	95.4%	93.0 - 97.0%
Age Unknown	1/1	100%	20.7 - 100%	1/1	100%	20.7 - 100%

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Image: Meridian Bioscience, Inc. logo	Special 510(k) Application illumigene C. difficile, Performance Characteristic Extension
	Description:	510(k) Summary illumigene C. difficile
	Identification:	Attachment 002
	Date:	December 31, 2010

Analytical Sensitivity (Reference K100818)

The analytical sensitivity of this assay for C. difficile was based on 20 replicates for each measurand and with a stated probability (e.g., 95% or 19/20 positive replicates) of obtaining positive responses at the following levels of the measurands:

Strain ID	Toxinotype	Phenotype	LoD/Test
VPI 10463	0	A+/B+	4 CFU/test
2007431	III (NAP1)	A+/B+	32 CFU/test
CF1	VIII	A-/B+	64 CFU/test
2006240	V (NAP7)	A+/B+	32 CFU/test
B18	III	A+/B+	64 CFU/test
2007858	IX/XXIII	A+/B+	32 CFU/test
8864	X	A-/B+	64 CFU/test

Additional C. difficile stock cultures from different sources were tested and produced positive reactions at 64 CFU/test with illumigene C. difficile. Strains and toxinotypes tested were as follows: Type 0 Strains: 10463, 2005070, 2005257, 2008029, 2008162, 2008341, 2008351, 2009099, B1, G1, J7, K12, Y1; Type III Strains: 2004052, 2004118, 2007431, B17, Bl8; Type V Strains: 2005325, 2006240, 2009018, 2009065, BK6; Type VIII Strains: 43598, 2008016, CF1; Type X Strains: 8864; Type XII Strains: 2007435; Type IX/XIII Strains: 2007858; Unknown Strains: 2009132, 2009277.

Reproducibility (Reference K100818)

Blind coded panels of 10 samples were supplied to three independent laboratories for precision studies. Samples were randomly sorted within each panel to mask sample included contrived samples manufactured at the assay limit of detection (n = 3) and just below the limit of blank (i.e., high negative sample, n = 3). The panels also included uncharacterized positive (n = 2) and negative (n = 2) samples. Testing was performed by different operators at each site on the same day (intra-assay variability) for five days (inter-assay variability). Three lots of illumigene C difficile were used in this study. The results are given in the table below:

	Site 1Percent agreement		Site 2Percent agreement		Site 3Percent agreement		TotalPercent agreement
Sample Type
Negative	20/20	100%	20/20	100%	19/19****	100%	59/59	100%
High Negative	25/30	83%	29/30	97%	28/30	93%	82/90	91%
Low Positive	30/30	100%	30/30	100%	30/30	100%	90/90	100%
Positive	20/20	100%	20/20	100%	20/20	100%	60/60	100%

**** 1 specimen generated an instrument invalid test result.

Conclusions

The illumigene C. difficile assay used in conjuntion with the illumipro-10 can be used to detect toxigenic C. difficile in human stool samples from pediatric and adult patients. The test is diagnostic for toxigenic C. difficile infection.

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Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized representation of three human profiles facing to the right, with flowing lines suggesting movement or connection.

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

Meridian Bioscience, Inc. c/o Ms. Michelle L. Smith Director Quality Systems 3471 River Hills Drive Cincinnati, OH 54244

FEB 2 4 2011

Re: K110012

Trade/Device Name: illumigene™ C. difficile DNA Amplification Assay Regulation Number: 21 CFR § 866.2660 Regulation Name: Microorganism differentiation and identification device Regulatory Class: Class I Product Codes: OMN Dated: December 31, 2010 Received: January 3, 2011

Dear Ms. Smith:

We have reviewed your Section 510(k) premarket notification of intent to market the indication indication we nave reviewed your becally be device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 101 use stated in the encreation to togals annual date of the Medical Device American on to comments provided 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). and Cosment Act (Act) that do not require subject to the general controls provisions of the Act. The Tou may, therefore, market the 80 ress, and include requirements for annual registration, listing of general controls provisions a ractice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into class II (Special Controls), it may be subject to such If your device is Classified (see acove) nike one affecting your device can be found in Title 21, 2011 in Title 21, 2011 additional collions. Existing major regulations are 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 Please be advised that FDA s issualic of a sudentify with other requirements of the Act
that FDA has made a determination that your device only of the Foreles. You must that FDA has made a decemination and regulations administered by other Federal and listing or any Federal statures and regulations connisting, but not limited to: registration and listing (21
comply with all the Act's requirements, 201 - 1000 - adject device report comply with all the Act 3 requirements morams) of in the reporting (reporting of
CFR Part 807); labeling (21 CFR Parts (21 and 809); and monufacturing practice CFK Part 807), labeling (21 CFR 803); and good manufacturing practice

{8}------------------------------------------------

Page 2 - Ms. Smith

requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter requirements as see gin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Sally A. Hojvat, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

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Indication(s) for Use Form

510(k) Number (if known): K-1 0 D I Z

Device Name: illumigene Molecular Diagnostic Test System (illumigene® C. difficile DNA Amplification Assay, illumipro-10™)

Indications for Use:

illumigene C. difficile is intended for use in hospital, reference or state laboratory settings. The device is not intended for point-of-care use.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)

Over-The-Counter Use _ (21 CFR 801 Subpart C) AND/OR

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Led Poly

on Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K110012

Regulation Number and Section

§ 866.2660 Microorganism differentiation and identification device.

(a)
Identification. A microorganism differentiation and identification device is a device intended for medical purposes that consists of one or more components, such as differential culture media, biochemical reagents, and paper discs or paper strips impregnated with test reagents, that are usually contained in individual compartments and used to differentiate and identify selected microorganisms. The device aids in the diagnosis of disease.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.