Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on real-time PCR technology and automated signal interpretation, with no mention of AI or ML terms.

Therapeutic

No
Explanation: The device is an in vitro diagnostic test intended as an aid in the diagnosis of C. difficile-associated disease (CDAD) by detecting a specific gene from stool specimens. It is not designed to treat or prevent a disease.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states that the device is "a rapid in vitro diagnostic test" and "is intended for use as an aid in diagnosis of CDAD."

SaMD (Software as a Medical Device)

No

The device description clearly states it is an in vitro diagnostic test that utilizes real-time PCR and involves physical specimens (stool), reagents, and a specific hardware instrument (Cepheid SmartCycler®) for amplification, detection, and interpretation. While software is used for interpretation, it is an integral part of a larger hardware-based system.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

Intended Use/Indications for Use: The very first sentence explicitly states: "The BD GeneOhm™ Cdiff Assay is a rapid in vitro diagnostic test..."
Device Description: The description reiterates that it is an "in vitro diagnostic test".
Function: The device performs a test on a human specimen (stool) outside of the body to aid in the diagnosis of a disease (CDAD). This is the core definition of an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The BD GeneOhm™ Cdiff Assay is a rapid in vitro diagnostic test for the direct, qualitative detection of C. difficile toxin B gene (todB) in human liquid or soft stool specimens from patients suspected of having Clostridium difficile-associated disease (CDAD). The test, based on real-time PCR, is intended for use as an aid in diagnosis of CDAD. The test is performed directly on the specimen, utilizing polymerase chain reaction (PCR) for the amplification of specific targets and fluorogenic target-specific hybridization probes for the detection of the amplified DNA.

Product codes (comma separated list FDA assigned to the subject device)

LLH

Device Description

The BD GeneOhm™ Cdiff Assay is a rapid in vitro diagnostic test for the direct, qualitative detection of C. difficile toxin B gene (todB) in human liquid or soft stool specimens from patients suspected of having Clostridium difficile-associated disease (CDAD). The test, based on real-time PCR, is intended for use as an aid in diagnosis of CDAD. The test is performed directly on the specimen, utilizing polymerase chain reaction (PCR) for the amplification of specific targets and fluorogenic target-specific hybridization probes for the detection of the amplified DNA.

A liquid or soft stool specimen is collected and transported to the laboratory. A sterile dry swab is dipped into the liquid or soft stool material and processed. For testing, the swab is eluted in sample buffer and the specimen is lysed. An aliquot of the lysate is added to PCR readents which contain the tcdB specific primers used to amplify the genetic target of Clostridium difficile, if present. The assay also includes an internal control (IC) to detect PCR inhibited specimens and to confirm the integrity of assay reagents. Amplified targets are detected with hybridization probes labelled with quenched fluorophores (molecular beacons). The amplification, detection and interpretation of the signals are done automatically by the Cepheid SmartCycler® software. The entire procedure takes about 75 to 90 minutes, depending on the number of specimens processed. The amplified DNA target is detected with a molecular beacon, a hairpin-forming singlestranded oligonucleotide labelled at one end with a quencher and at the other end with a fluorescent reporter dye (fluorophore). In the absence of target, the fluorescence is quenched. In the presence of target, the hairpin structure opens upon beacon/target hybridization, resulting in emission of fluorescence. For the detection of tcdB amplicons, the molecular beacon contains the fluorophore FAM at the 5' end and the nonfluorescent quencher DABCYL at the opposite 3' end of the oligonucleotide. For the detection of the IC amplicons, the molecular beacon contains the fluorophore TET at the 5' end and the quencher moiety DABCYL at the 3' end. Each beacon-target hybrid fluoresces at a wavelength characteristic of the fluorophore used in the particular molecular beacon. The amount of fluorescence at any given cycle, or following cycling, depends on the amount of specific amplicons present at that time. The SmartCycler software simultaneously monitors the fluorescence emitted by each molecular beacon, interprets all data, and provides a final result at the end of the cycling program.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Stool

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Performance characteristics of the BD GeneOhm™ Cdiff Assay were determined in a multi-site prospective investigational study. Four (4) medical centers, two (2) in Canada and two (2) in the United States, participated in the study. To be enrolled in the study, specimens had to be from individuals for whom Clostridium difficile testing was indicated and/or ordered, according to institutional policies.

The Reference Cytotoxicity Assay was performed using a tissue culture Cytotoxicity assay on liguid or soft stool specimens within 48 hours of collection. The procedure was performed according to the Manufacturer's Instructions for Use.

A total of 1108 specimens were tested with both the Reference Assay described above and the BD GeneOhm™ Cdiff Assay, producing 1090 reportable results. The first dataset includes 835 fresh specimens tested at three (3) of the four (4) clinical sites. Testing at the fourth clinical site revealed that the Reference Cytotoxicity Assay was not reporting accurate results. Due to the high number of inaccurate reference assay results, samples were retested from aliquots of the original stool specimens which had been frozen after the initial testing. These frozen aliquots were tested with both the Reference Assay and the BD GeneOhm™ Cdiff Assay. The second dataset includes results from 255 frozen stool specimens available for analysis.

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Study Type: Multi-site prospective investigational study.
Sample Size:

Overall: 1108 specimens (1090 reportable results)
Fresh specimens: 835
Frozen specimens: 255
Key Results (Fresh Stools, N=835):
Sensitivity: 93.8% (76/81) with 95% CI (86.2% - 98.0%)
Specificity: 95.5% (720/754) with 95% CI (93.8% - 96.9%)
Negative Predictive Value (NPV): 99.1%
Positive Predictive Value (PPV): 67.3%
Key Results (Frozen Stools, N=255):
Sensitivity: 100.0% (34/34) with 95% CI (89.7% - 100%)
Specificity: 97.7% (216/221) with 95% CI (94.8% - 99.3%)
Negative Predictive Value (NPV): 99.2%
Positive Predictive Value (PPV): 81.5%

Unresolved Rates:

Fresh Stools: Initial unresolved rate 4.6% (39/852), resolved to 2.0% (17/852) after repeat.
Frozen Stools: Initial unresolved rate 0.4% (1/256), remained 0.4% (1/256) after repeat.
Overall Invalid Run Rates: 0.6% (1/160).

Analytical Specificity:
Tested genomic DNA from one non toxigenic C. difficile strain, two strains of Toxinotype XI lacking tcdB gene, 29 other-Clostridium strains, 99 closely related organisms and other pathogenic/commensal flora (representing 96 species) at approximately 1X10^8 CFU/mL or 1X10^6 target copies/mL. None of these tested positive.

Analytical Sensitivity (Limit of Detection - LOD):

Determined with one strain of Toxinotype 0 Clostridium difficile (ATCC 43255).
LOD: 10 DNA copies per reaction.
LOD in Colony Forming Units (CFU): 4 CFU per reaction.
Confirmed with a second Toxinotype 0 (ATCC 9689) and with Toxinotypes IIIa (SE844), VII (57267) and VIII (1470) Clostridium difficile toxigenic strains.
100 other toxigenic C. difficile strains (including 17 other Toxinotypes) from clinical isolates or public collections were evaluated. The assay correctly identified all 100 C. difficile strains carrying the tcdB gene at approximately 6.7 DNA copies/uL or 1 CFU/μL.

Reproducibility:

Site-to-Site Reproducibility (one lot): Low positive C. difficile specimen category 96.7% agreement, moderate positive 100%, negative 100%.
Lot-to-Lot Reproducibility (three lots): Low positive C. difficile specimen category 100% agreement, moderate positive 97.8%, negative 100%.
Additional Reproducibility Study (high negative samples below LOD): More dilute panel (100-fold below LOD) showed higher percent agreement for negative test results than less dilute (10-fold below LOD).

Precision:

Within-laboratory precision evaluated at one site over 12 days (two runs/day, two sample replicates/run).
Low positive samples: 46/46 agreement.
Moderate positive samples: 45/46 agreement.
Negative samples: 46/46 agreement.

Interfering Substances:

26 biological and chemical substances evaluated.
Excessive blood may inhibit PCR and give unresolved results.
24 substances showed no detectable interference.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Fresh Stools:

Sensitivity: 93.8% (95% CI: 86.2% - 98.0%)
Specificity: 95.5% (95% CI: 93.8% - 96.9%)
Negative Predictive Value: 99.1%
Positive Predictive Value: 67.3%
Frozen Stools:
Sensitivity: 100.0% (95% CI: 89.7% - 100%)
Specificity: 97.7% (95% CI: 94.8% - 99.3%)
Negative Predictive Value: 99.2%
Positive Predictive Value: 81.5%

Unresolved Rates:

Fresh Stools (Initial): 4.6% (95% CI: 3.3% - 6.2%)
Fresh Stools (After Repeat): 2.0% (95% CI: 1.2% - 3.2%)
Frozen Stools (Initial and After Repeat): 0.4% (95% CI: 0.0% - 2.2%)

Overall Invalid Run Rates: 0.6% (95% CI: 0.0% - 3.4%)

Reproducibility (Overall Percent Agreement):

Site-to-Site:
- NEG: 100.0%
- LOW POS: 96.7%
- MOD POS: 100.0%
Lot-to-Lot:
- NEG: 100.0%
- LOW POS: 100.0%
- MOD POS: 97.8%

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K935296, K923463

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

0

Kori20

510(k) Summary

DEC 1 9 2008

December 17, 2008

BD Diagnostics BD GeneOhm™ Cdiff Assay

BD Diagnostics (GeneOhm Sciences Canada, Inc.) Submitted by: 2050, boul. René-Lévesque O, 4ª étage Sainte-Foy, Québec Canada G1V 2K8

| Contact/

U.S. Agent:	Raymond Boulé
	BD Diagnostics - GeneOhm
	6146 Nancy Ridge Drive
	San Diego, CA 92121 USA

Name of Device:

Trade Name:	BD GeneOhm™ Cdiff Assay
Common Name:	Clostridium difficile tcdB detection assay
Classification Name:	System, Test, Genotypic Detection, Clostridium difficile
Toxin B
Predicate Device:	Techlab C. difficile Tox-B Test (K935296)
Techlab Clostridium difficile Toxin/Antitoxin Kit (K923463)

Device Description:

Intended Use:

The BD GeneOhm™ Cdiff Assay is a rapid in vitro diagnostic test for the direct, qualitative detection of C. difficile toxin B gene (todB) in human liquid or soft stool specimens from patients suspected of having Clostridium difficile-associated disease (CDAD). The test, based on real-time PCR, is intended for use as an aid in diagnosis of CDAD. The test is performed directly on the specimen, utilizing polymerase chain reaction (PCR) for the amplification of specific targets and fluorogenic target-specific hybridization probes for the detection of the amplified DNA.

Test Description:

A liquid or soft stool specimen is collected and transported to the laboratory. A sterile dry swab is dipped into the liquid or soft stool material and processed. For testing, the swab is eluted in sample buffer and the specimen is lysed. An aliquot of the lysate is added to PCR readents which contain the tcdB specific primers used to amplify the genetic target of Clostridium difficile, if present. The assay also includes an internal control (IC) to detect PCR inhibited specimens and to confirm the integrity of assay reagents. Amplified targets are detected with hybridization probes labelled with quenched fluorophores (molecular beacons). The amplification, detection and interpretation of the signals are done automatically by the Cepheid SmartCycler® software. The entire procedure takes about 75 to 90 minutes, depending on the number of specimens processed.

1

The amplified DNA target is detected with a molecular beacon, a hairpin-forming singlestranded oligonucleotide labelled at one end with a quencher and at the other end with a fluorescent reporter dye (fluorophore). In the absence of target, the fluorescence is quenched. In the presence of target, the hairpin structure opens upon beacon/target hybridization, resulting in emission of fluorescence. For the detection of tcdB amplicons, the molecular beacon contains the fluorophore FAM at the 5' end and the nonfluorescent quencher DABCYL at the opposite 3' end of the oligonucleotide. For the detection of the IC amplicons, the molecular beacon contains the fluorophore TET at the 5' end and the quencher moiety DABCYL at the 3' end. Each beacon-target hybrid fluoresces at a wavelength characteristic of the fluorophore used in the particular molecular beacon. The amount of fluorescence at any given cycle, or following cycling, depends on the amount of specific amplicons present at that time. The SmartCycler software simultaneously monitors the fluorescence emitted by each molecular beacon, interprets all data, and provides a final result at the end of the cycling program.

Substantial Equivalence:

The BD GeneOhm™ Cdiff Assay has been found to be substantially equivalent to the Techlab C. difficile Tox-B Test (K935296) and the Techlab Clostridium difficile Toxin/Antitoxin Kit (K923463). These methods were used as the reference methods in the clinical trials.

Performance Characteristics:

Performance characteristics of the BD GeneOhm™ Cdiff Assay were determined in a multi-site prospective investigational study. Four (4) medical centers, two (2) in Canada and two (2) in the United States, participated in the study. To be enrolled in the study, specimens had to be from individuals for whom Clostridium difficile testing was indicated and/or ordered, according to institutional policies.

The Reference Cytotoxicity Assay was performed using a tissue culture Cytotoxicity assay on liguid or soft stool specimens within 48 hours of collection. The procedure was performed according to the Manufacturer's Instructions for Use.

A total of 1108 specimens were tested with both the Reference Assay described above and the BD GeneOhm™ Cdiff Assay, producing 1090 reportable results. The first dataset includes 835 fresh specimens tested at three (3) of the four (4) clinical sites (Table 1). In comparison to the Reference Assay, the BD GeneOhm™ Cdiff Assay identified 93.8% of the C. difficile positive specimens and 95.5% of the negative specimens (Table 2). For the population tested this resulted in a Negative Predictive Value (NPV) of 99.1% and a Positive Predictive Value (PPV) of 67.3%.

Testing at the fourth clinical site revealed that the Reference Cytotoxicity Assay was not reporting accurate results. Due to the high number of inaccurate reference assay results, samples were retested from aliquots of the original stool specimens which had been frozen after the initial testing. These frozen aliquots were tested with both the Reference Assay and the BD GeneOhm™ Cdiff Assay. The second dataset includes results from 255 frozen stool specimens available for analysis (Table 3).

2

In comparison to the Reference Assay, the BD GeneOhm™ Cdiff Assay identified 100% of the C. difficile positive specimens and 97.7% of the negative specimens in the frozen dataset: resulting in a NPV of 99.2% and PPV of 81.5% (Table 4).

Out of 852 fresh specimens tested with the BD GeneOhm™ Cdiff Assay, 39 were initially reported as unresolved (4.6%). Upon repeat testing from the frozen lysates, 22 were resolved and 17 remained unresolved (2.0%) (Table 5). Out of 256 frozen specimens tested with the BD GeneOhm™ Cdiff Assay, only one (1) specimen (0.4%) was initially reported unresolved. The specimen remained unresolved upon repeat testing from the frozen lysate (0.4%) (Table 6). One (1) run was reported invalid due to Run Control failure (0.6%). The run was reported valid upon repeat testing of the specimen lysates (Table 7).

Table 1: Fresh Stool Results Obtained with the BD GeneOhm™ Cdiff Assay in Comparison with the Reference Assay

Image /page/2/Figure/3 description: This image shows a table comparing the BD GeneOhm Cdiff Assay with a reference cytotoxicity assay. The table is a 2x2 matrix, with the rows representing the results of the BD GeneOhm Cdiff Assay (+ or -) and the columns representing the results of the reference cytotoxicity assay (+ or -). The table shows the number of samples that had each combination of results. For example, 76 samples were positive for both assays, while 720 samples were negative for both assays.

Cytotoxicity Assay on isolated strains was positive for 21 out of the 34 samples, verifying the presence of toxigenic C. difficile. For the remaining 13 samples, standard PCR with alternative primers followed by bi-directional sequencing revealed that 11 out of the 13 samples contained the expected todB gene. + For two (2) of the five (5) false negative specimens, C. difficile was recovered by culture, and only one (1) of these two (2) was reported as toxigenic. Of the remaining three (3) false negative PCR specimens, no C. difficile was recovered by culture.

Table 2: Performance Obtained with Fresh Stools using the BD GeneOhm™ Cdiff
Assay in Comparison with the Reference Method

Clinical Sites	Prevalence	Sensitivity with 95% CI*	Specificity with 95% CI*
Site 1	11.0% (40/365)	90.5% (38/42) (77.4% - 97.3%)	95.7% (309/323) (92.8% - 97.6%)
Site 2	6.7% (16/240)	94.4% (17/18) (72.7% - 99.9%)	96.4% (240/249) (93.2% - 98.3%)
Site 3	11.1% (18/162)	100% (21/21) (83.9% - 100%)	94.0% (171/182) (89.4% - 96.9%)
Overall	9.6% (74/767)	93.8% (76/81) (86.2% - 98.0%)	95.5% (720/754) (93.8% - 96.9%)

CI: Confidence Intervals

3

Table 3: Frozen Stool Results Obtained with the BD GeneOhm™ Cdiff Assay in Comparison with the Reference Assay

Image /page/3/Figure/1 description: This image shows a table comparing the BD GeneOhm Cdiff Assay with a reference cytotoxicity assay. The table is a 2x2 matrix, with rows representing the BD GeneOhm Cdiff Assay results (+ and -) and columns representing the reference cytotoxicity assay results (+ and -). The table shows the following values: 34 for (+,+), 5 for (+,-), 0 for (-,+), and 216 for (-,-). The row totals are 39 and 216, and the column totals are 34 and 221, with a grand total of 255.

Table 4: Performance Obtained with Frozen Stools using the BD GeneOhm™ Cdiff Assay in Comparison with the Reference Method

Clinical Site	Prevalence	Sensitivity with 95% CI*	Specificity with 95% CI*
Site 4	12.7% (34/267)	100.0% (34/34) (89.7% - 100%)	97.7% (216/221) (94.8% - 99.3%)

CI: Confidence Intervals

Table 5: Fresh Stool Unresolved Rates

| Clinical Sites | Initial unresolved rate with
95% CI* | | Unresolved rate after repeat with
95% CI* | |
|----------------|-----------------------------------------|----------------|----------------------------------------------|---------------|
| Site 1 | 0.8% (3/367) | (0.2% - 2.4%) | 0.5% (2/367) | (0.1% - 2.0%) |
| Site 2 | 6.6% (18/273) | (4.0% - 10.2%) | 2.2% (6/273) | (0.8% - 4.7%) |
| Site 3 | 8.5% (18/212) | (5.1% - 13.1%) | 4.2% (9/212) | (2.0% - 7.9%) |
| Overall | 4.6% (39/852) | (3.3% - 6.2%) | 2.0% (17/852) | (1.2% - 3.2%) |

CI: Confidence Intervals

Table 6: Frozen Stool Unresolved Rates

| Clinical Site | Initial unresolved rate with
95% CI* | Unresolved rate after repeat with
95% CI* |
|---------------|-----------------------------------------|----------------------------------------------|
| Site 4 | 0.4% (1/256) (0.0% - 2.2%) | 0.4% (1/256) (0.0% - 2.2%) |

CI: Confidence Intervals

Table 7: Overall Invalid Run Rates

Site	Invalid Run Rates with 95% Cl*
Site 1	2.6% (1/38)	(0.1% - 13.8%)
Site 2	0.0% (0/41)	(0.0% - 8.6%)
Site 3	0.0% (0/58)	(0.0% - 6.2%)
Site 4	0.0% (0/23)	(0.0% - 14.8%)
Overall	0.6% (1/160)	(0.0% - 3.4%)

CI: Confidence Intervals

4

Analytical Specificity

Genomic DNA from one non toxigenic C. difficile strain, two strains of Toxinotype XI lacking tcdB gene and 29 other-Clostridium strains (including one strain of C. sordelli), along with 99 closely related organisms and other pathogenic and commensal flora found in the intestine and stools (representing 96 species) were tested. All strains were tested at a concentration of approximately 1X108 CFU/mL or 1X10° target copies/mL. None of these species tested positive with the BD GeneOhm™ Cdiff Assay (Attachment 1).

Analytical Sensitivity

Quantitated culture and purified genomic DNA diluted in BD GeneOhm™ Cdiff Assay sample buffer were tested in five (5) replicates. The LOD was defined as the lowest concentration, in DNA copy number per reaction and CFU per reaction, at which five replicates out of five were found positive.

The analytical sensitivity (limit of detection or LOD) of the BD GeneOhm™ Cdiff Assay was determined with one strain of Toxinotype 0 Clostridium difficile carrying the tcdB gene (ATCC 43255).

The BD GeneOhm™ Cdiff Assay LOD is 10 DNA copies per reaction. The LOD in Colony Forming Units (CFU) is established at 4 CFU per reaction.

The analytical sensitivity in CFU per reaction was confirmed with a second Toxinotype 0 (ATCC 9689) and with Toxinotypes Illa (SE844), VII (57267) and VIII (1470) Clostridium difficile toxigenic strains.

In addition to strains used for LOD determination, one hundred (100) other toxigenic C. difficile strains (including 17 other Toxinotypes), representing 21 countries, from wellcharacterized clinical isolates or public collections were evaluated using the BD GeneOhm™ Cdiff Assay. C. difficile strains were tested at a concentration of approximately 6.7 DNA copies/uL or 1 CFU/μL. The assay correctly identified all 100 C. difficile strains carrying the tcdB gene.

Reproducibility

The reproducibility panel consisted of three (3) simulated specimen categories where each tube contained 100 uL of simulated bowel flora; the two positive panel members were also inoculated with C. difficile (ATCC 43255). Additionally, two (2) Specimen Processing Controls (ATCC 9689 and ATCC 25922) and, two (2) Run Controls (Positive and Negative) were included. The specimens were tested in triplicate per panel run, on five (5) distinct days (consecutive or not), wherein each day two (2) panels were tested, one for each of two (2) technologists, at three (3) clinical sites with one (1) lot of reagents. One (1) of these clinical sites participated in the extended study where two (2) additional lots of reagents were tested.

5

The overall percent agreement for the low positive C. difficile specimen category is 96.7%; the moderate positive C. difficile specimen category is 100% and the negative specimen category is 100% for the Site-to-Site Reproducibility (Table 8).

The overall percent agreement for the low positive C. difficile specimen category is 100%; the moderate positive C. difficile specimen category is 97.8% and the negative specimen category is 100% for the Lot-to-Lot Reproducibility (Table 9). Cycle threshold (Ct), an internal criteria used to determine a final assay result, was selected as an additional means of assessing assay reproducibility. Overall mean Ct values with variance components (SD and %CV) are shown in Tables 8 and 9.

An additional reproducibility study was performed, in accordance with the original reproducibility study protocol, to assess high negative specimens below the BD GeneOhm™ Cdiff Assay limit of detection (LOD). A sample containing simulated bowel flora was inoculated with C. difficile (ATCC 43255) at a concentration equivalent to the assay LOD. 100-fold and 10-fold dilutions of this sample were prepared, respectively, to obtain the two (2) high negative panel members. Overall percent agreement for negative test results and overall mean Ct values with variance components (SD and %CV) are shown in Table 10. As expected, the more dilute panel member (100-fold below the LOD) containing lower levels of target, demonstrates a higher percent agreement for negative test results than the less dilute panel member (10-fold below the LOD) which contains higher levels of target. Although high negative panel members are below the analytical LOD of the assay, positive test results may still be observed due to the presence of target in these specimens.

| SITE | | | Overall Percent
Agreement | Ct Values | | | |
|----------|-----------------|-----------------|------------------------------|-----------------|--------------|------|-------|
| Category | Site 1 | Site 2 | | Site 3 | Overall Mean | SD | %CV |
| NEG | 30/30
100.0% | 30/30
100.0% | 30/30
100.0% | 90/90
100.0% | 36.2† | 0.3† | 0.8%† |
| LOW POS | 28/30
93.3% | 29/30
96.7% | 30/30
100.0% | 87/90
96.7% | 38.8 | 0.9 | 2.3% |
| MOD POS | 30/30
100.0% | 30/30
100.0% | 30/30
100.0% | 90/90
100.0% | 38.3 | 1.0 | 2.7% |

Table 8: Site-To-Site Reproducibility Study Results using One Lot

Data represent values from the internal control.

Table 9: Lot-To-Lot Reproducibility Study Results using Three Lots

LOT						Ct Values
Category	Lot 1		Lot 2		Lot 3		Overall Percent
Agreement
	Percent Agreement		Percent Agreement		Percent Agreement				Overall
Mean	SD	%CV
NEG	30/30	100.0%	30/30	100.0%	30/30	100.0%	90/90	100.0%	36.1‡	0.3‡	0.8%‡
LOW POS	30/30	100.0%	30/30	100.0%	30/30	100.0%	90/90	100.0%	38.6	1.0	2.5%
MOD POS	29/30	96.7%	29/30	96.7%	30/30	100.0%	88/90	97.8%	37.8	1.1	2.8%

4 Data represent values from the internal control.

6

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MAYAYAYAYAYAYAYAAAATAYAYAYAYAYAYAYAYAYAYAY
. | AN MATHINASALEAS WS SATAY A V A T A T A T A T A S M S M S M S M S M S M S M S M S M S M S M S M S M S M S M S M S M S M S M S M S M S M S M S M S M S M S M S M S M S M S M S
YA WAY WASHINGWAY ANARA YA YA YA YA YA YA YA YA YA YA YA YA YA YA YA YA YA YA YA YA YA | TATATATATATATATATATATATATATATATATATAAAAAAAAAAAAAAAAAAAA | | | ATWA WENDAYAYAYAYAYAYAYAYAYAYAYAYAYAYAYAYAYAYAYAYAYAY | ****************************************************************************************************************************************************************************** | A Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Ca | | |
| AAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAA | W N A P M A P M A P A Y A Y A Y A Y A Y A Y A Y A Y A Y A Y A Y A Y A Y A Y A Y A Y A Y A Y A Y A Y A Y A Y A Y A Y A Y A Y A Y A Y A Y A Y A Y A Y A Y A Y A Y A Y A Y A Y A | APAYAYAYAYAYAYAYAYAYAYAYAYAYAYAYAYAYAYAY WAYAYAYAYA | | ****************************************************************************************************************************************************************************** | | | | | |
| children and stock of all of the first and one of the first of the first of the first of the productions of the production | | | | | | | | | |
| | | | | | | | | | |
| | | 21/20 | | | | | | | |
| | | | | | | | | | |
| | | | | | | | | | |
| AVATANAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAA | | | | | | | | | |
| YAYAWAWARAYAYAYAYAYAYAYAYAYAAAAW | | | | | | | | | |
| | | | | | | | | | |
| | | | | | | | | | |
| .
****************************************************************************************************************************************************************************** | | | | | | | | | |
| | | | | | | | | | |

Table 10: Additional Reproducibility Study Using a High Negative Sample Panel

*Percent agreement for a negative result.

Precision

Within-laboratory precision was evaluated for the BD GeneOhm Cdiff Assay at one (1) site. The study was performed over 12 days, with two (2) runs per day and two (2) sample replicates per run. Samples included simulated specimens representing low and moderate positive C. difficile as well as negative C. difficile. One (1) out of 24 runs was excluded due to failure of the positive control (PC). One (1) moderate positive sample produced an unresolved result. All remaining samples and controls produced reportable results for a total of 46 replicates. Precision study results for low and moderate positive samples demonstrated agreement for (46/46) and (45/46) replicates, respectively; negative sample results demonstrated agreement for (46/46) replicates.

7

Interfering Substances

Twenty-six (26) biological and chemical substances occasionally used or found in perianal, rectal and/or stool specimens were evaluated for interference with the BD GeneOhm™ Cdiff Assay. Potentially interfering substances include, but are not limited to, blood and mucus. The presence of excessive blood may inhibit PCR and may give unresolved results. The remaining twenty-four (24) substances illustrated in the table below showed no detectable interference with the BD GeneOhm™ Cdiff Assay.

Endogenous and Commercial Exogenous Substances Tested with the BD GeneOhm Cdiff Assay

Substance	Result
AnusolMC Plus *	NI**
Atlas Ihle's Paste *
Zinc oxide 25 % w/w paste (Laboratoire Atlas Inc.)	NI
Barium sulfate
Fresh solution from powder form (LabMat)	NI
Exact™ Hydrocortisone acetate * Cream
USP 0.5 % (Taro Pharmaceuticals Inc.)	NI
Exact™ stomach relief
Bismuth subsalicylate liquid (Perrigo®)	NI
Fecal fat	NI
Fresh control® Moist towelettes pH 5,5 (Blue Skin)	NI
Gyne Moistrin®Vaginal moisturizing gel (Schering)	NI
Imodium AD® *
Loperamide hydrochloride oral solution (McNeil)	NI
Kaopectate®
Oral attaplugite suspension (Pharmacia & Upjohn)	NI
K-Y® Jelly (Johnson & Johnson Inc.)	NI
Metronidazole
Fresh solution from powder form (Acros Organics)	NI
Substance	Result
MonistatTM Derm
Miconazole nitrate cream USP 2% (McNeil)	NI
Palmitic acid *
Fresh solution from powder (LabMat)	NI
Preparation H® with Bio-Dyne® *
Cream (Wyeth)	NI
Preparation H® with Bio-Dyne® *
Ointment (Wyeth)	NI
Rougier Neo-Laryngobis *Suppositories
(Rougier Pharma)	NI
SAB-Dimenhydrinate® * Suppositories
(SABEX®)	NI
Steric acid *
Fresh solution from powder (LabMat)	NI
Trojan® latex condoms (with nonoxynol-9)
Spermicidal lubricant (Church & Dwight Co., Inc.)	NI
TucksMC personal cleansing pads
Moist, soft clothpads (Pfizer)	NI
Vagisil® Anti-itch cream (Combe Incorporated)	NI
Vancomycin
Liquid (MP Biomedicals, LLC)	NI
VaselineTM *
White petroleum jelly U.S.P. (Lever Pond's)	NI

Substance tested with two strains of C. difficile (Tox 0 and Tox VIII) ** NI: No detectable interference with the BD GeneOhm Cdiff Assay

8

| Genera and Species Assay |
|---------------------- | Abiotrophia defective | Acinetobacter baumannii | Acinetobacter Iwoffii | Aeromonas hydrophila | Alcaligenes | Anaerococcus tetradius | Bacillus cereus | Bacillus cereus | Bacteroides caccae | Bacteroides merdae | Bacteroides stercoris | Bifidobacterium adolescentis | Bifidobacterium longum | Campylobacter coli | Campylobacter | Candida albicans | Candida catenulate | Cedecea davisae | Chlamydia trachomatis | Citrobacter amalonaticus | Citrobacter freundii | Citrobacter koseri | Citrobacter sedlakii | Clostridium beijerinckii | Clostridium bifermentans | Clostridium bolteae | Clostridium botulinum | Clostridium butyricum | Clostridium chauvoei | Clostridium | Clostridium | Clostridium | Clostridium fallax | Clostridium haemolyticum | Clostridium histolyticum | Clostridium innocuum | Clostridium methylpentosum | Clostridium nexile | Clostridium novyi | Clostridium orbiscindens | Clostridium paraputrificum | Clostridium perfringens | Clostridium ramosum | Clostridium scindens | Clostridium septicum | Genera and Species | Clostridium sordellii | Clostridium sp | Clostridium sp | Clostridium sphenoides | Clostridium spiroforme | Clostridium sporogenes | Clostridium symbiosum | Clostridium symbiosum | Clostridium tertium | Clostridium tetani | Collinsella aerofaciens | Corynebacterium genitalium | Desulfovibrio piger | Edwardsiella tarda | Eggerthella lenta | Enterobacter aerogenes | Enterobacter cloacae | Enterococcus | Enterococcus cecorum | Enterococcus dispar | Enterococcus faecalis vanB | Enterococcus faecium vanA | Enterococcus gallinarum vanC | Enterococcus hirae | Enterococcus raffinosus | Escherichia coli | Escherichia coli | Escherichia fergusonii | Escherichia hermannii | Fusobacterium varium | Gardnerella vaginalis | Gemella morbillorum | Hafnia alvei | Helicobacter fennelliae | Helicobacter pylori | Homo sapiens | Klebsiella oxytoca | Klebsiella oxytoca | Klebsiella pneumoniae | Lactobacillus acidophilus | Lactobacillus reuteri | Lactococcus lactis | Leminorella grimontii | Listeria grayi | Listeria innocua | Listeria monocytogenes | Mitsuokella multacida | Mobiluncus curtisii | Moellerella wisconsensis | Morganella morganii | Neisseria gonorrhoeae | Genera and Species | Peptoniphilus asaccharolyticus | Peptostreptococcus anaerobius | Plesiomonas shigelloides | Porphyromonas asaccharolytica | Prevotella melaninogenica | Proteus mirabilis | Proteus penneri | Providencia alcalifaciens | Providencia rettgeri | Providencia stuartii | Pseudomonas aeruginosa | Pseudomonas putida | Ruminococcus bromii | Salmonella choleraesuis | Salmonella enterica choleraesuis arizonae) | Salmonella enterica Salmonella choleraesuis | Serratia liquefaciens | Serratia marcescens2 | Shigella boydii | Shigella dysenteriae | Shigella sonnei | Staphylococcus aureus3 | Staphylococcus epidermidis | Stenotrophomonas maltophilia | Streptococcus agalactiae | Streptococcus dysgalactiae | Streptococcus intermedius | Streptococcus uberis | Trabulsiella guamensis | Veillonella parvula | Vibrio cholerae | Vibrio parahaemolyticus | Yersinia bercovieri | Yersinia rohdei | Yokenella regensburgei | Strain | BD GeneOhmTM Cdiff
-------------------------------------------------------------------------|-----------------------|-----------------------------|
| ATCC 49176 | neg |
| ATCC 19606 | neg |
| CDCF 3697 | neg |
| ATCC 7966/ CCRI-10071 | neg |
faecalis subsp. Faecalis | ATCC 15554 | neg |
| ATCC 35098 | neg |
| ATCC 13472 | neg |
| HER 1414 | neg |
| ATCC 43185 | neg |
| ATCC 43184 | neg |
| ATCC 43183 | neg |
| ATCC 15703 | neg |
| ATCC 15707 | neg |
| ATCC 43479 | neg |
jejuni subsp. jejuni | ATCC 33292 | neg |
| ATCC 10231 | neg |
| IDI-1729 | neg |
| ATCC 33431 | neg |
| ABI 08-901-000 | neg |
| ATCC 25405 | neg |
| ATCC 8090 | neg |
| ATCC 27028 | neg |
| ATCC 51115 (IDI-2178) | neg |
| ATCC 8260 | neg |
| ATCC 638 | neg |
| BAA-613 | neg |
| Hall A | neg |
| CCRI-11128 | neg |
| ATCC 11957 | neg |
difficile non-toxigenic | ATCC-700057 | neg |
difficile Xla (A-B-tox bin+) | IS58 | neg |
difficile XIb (A-B-tox bin+) | R11402 | neg |
| ATCC 19400 | neg |
| ATCC 9650 | neg |
| ATCC 19401 | neg |
| CCRI-9927 / IDI 1986 | neg |
| ATCC 43829 | neg |
| ATCC 27757 | neg |
| ATCC 19402 | neg |
| ATCC 49531 | neg |
| ATCC 25780 | neg |
| ATCC 13124 | neg |
| ATCC 25582 | neg |
| ATCC 35704 | neg |
| ATCC 12464 | neg |
| Strain | BD GeneOhm™ Cdiff Assay |
| ATCC 9714 | neg |
| CCRI-9842 / IDI 1987 | neg |
| CCRI-9929 / IDI-1988 | neg |
| ATCC 19403 | neg |
| ATCC 29899 | neg |
| ATCC 15579 | neg |
| CCRI-9928 / IDI 1989 | neg |
| ATCC 14940 | neg |
| ATCC 14573 | neg |
| ATCC 19406 | neg |
| ATCC 25986 | neg |
| LSPQ 3583 | neg |
| ATCC 29098 | neg |
| ATCC 15947 | neg |
| CCRI-9926 / IDI 1990 | neg |
| ATCC 13048 | neg |
| ATCC 13047 | neg |
casseliflavus (vanC2) | CCRI-1566 / IDI 1981 | neg |
| ATCC 43198 | neg |
| ATCC 51266 | neg |
| ATCC 51299 | neg |
| ATCC 700221 | neg |
| CCRI-1561 / IDI 1982 | neg |
| ATCC 8043 | neg |
| ATCC 49427 | neg |
| ATCC 23511 | neg |
| Top10 (IDI-266) | neg |
| ATCC 35469 | neg |
| ATCC 33650 | neg |
| ATCC 8501 | neg |
| ATCC 14019 | neg |
| ATCC 27824 | neg |
| ATCC 13337 | neg |
| ATCC 35683 / IDI-2180 | neg |
| ATCC 43504 | neg |
| ATCC MGC-15492 / 2.16 | neg |
| ATCC 33496 | neg |
| ATCC 33497 | neg |
subsp. Pneumoniae | ATCC 13883 | neg |
| ATCC 4356 | neg |
| ATCC 23272 | neg |
| ATCC 11454 | neg |
| ATCC 33999 | neg |
| ATCC 19120 | neg |
| ATCC 33090 | neg |
| L374 | neg |
| ATCC 27723 | neg |
subsp. Holmesii | ATCC 35242 | neg |
| ATCC 35017 | neg |
subsp. morganii | ATCC 25830 | neg |
| ATCC 35201 | neg |
| Strain | BD GeneOhm™ Cdiff Assay |
| ATCC 14963 | neg |
| ATCC 27337 | neg |
| ATCC 14029 | neg |
| ATCC 25260 | neg |
| ATCC 25845 | neg |
| ATCC 25933 | neg |
| ATCC 35198 | neg |
| ATCC 9886 | neg |
| ATCC 9250 | neg |
| ATCC 33672 | neg |
| ATCC 35554 | neg |
| LCDC D7172 | neg |
| ATCC 27255 | neg |
(typhimurium) | ATCC 14028 | neg |
subsp. Arizonae (formerly
| ATCC 13314 | neg |
subsp. Enterica (formerly
subsp. choleraesuis) | ATCC 7001 | neg |
| ATCC 27592 | neg |
| ATCC 13880 | neg |
| ATCC 9207 | neg |
| ATCC 11835 | neg |
| ATCC 29930 | neg |
| ATCC 43300 | neg |
| ATCC 14990 | neg |
| ATCC 13637 | neg |
| ATCC 12973 | neg |
| ATCC 43078 | neg |
| ATCC 27335 | neg |
| ATCC 19436 | neg |
| ATCC 49490 | neg |
| ATCC 10790 | neg |
| ATCC 25870 | neg |
| ATCC 17802 | neg |
| ATCC 43970 | neg |
| ATCC 43380 | neg |
| ATCC 35313 | neg |

Attachment 1: BD GeneOhm™ Cdiff Assay Reactivity Study using DNA and Lysates from Various Species

9

10

A SC curve with a strong background was obtained at the first testing leading to a positive status.

Retest in triplicate generated a final negative result.

in a con of the artistic and and and and and and of the one of the one of the one of the one of the one of the fin
t Two lysates were prepared because the first one gave an

*Tested with two lots of isolated DNA

11

Image /page/11/Picture/0 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" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, rendered in black.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Raymond J Boule Senior Director, Regulatory Affairs, Quality Assurance BD Diagnostics (GeneOhm Sciences Inc.) 6146 Nancy Ridge Drive San Diego, CA 92121

DEC 1 9 2008

Re: K081920

Trade/Device Name: BD GeneOhm™ Cdiff Assay Regulation Number: 21 CFR § 866.2660 Regulation Name: Clostridium difficile toxin Regulatory Class: I Product Code: LLH Dated: July 2, 2008 Received: July 3, 2008

Dear Mr. Boule:

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).

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally

12

Page 2 -

This letter will allow you to begin 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 Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at 240-276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric''s (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Sally attayna

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

Enclosure

13

Indications For Use Statement

510(k) Number (if known): _ K081920

Device Name: BD GeneOhm™ Cdiff Assay

Indications For Use

Intended Use:

The BD GeneOhm™ Cdiff Assay is a rapid in vitro diagnostic test for the direct, qualitative detection of C. difficile toxin B gene (tcdB) in human liguid or soft stool specimens from patients suspected of having Clostridium difficile-associated disease (CDAD). The test, based on real-time PCR, is intended for use as an aid in diagnosis of CDAD. The test is performed directly on the specimen, utilizing polymerase chain reaction (PCR) for the amplification of specific targets and fluorogenic target-specific hybridization probes for the detection of the amplified DNA.

Prescription Use	XXX
(Per 21 CFR 801.109)

OR

Over-The-Counter Use
(Optional Format 1-2-96)

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

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

Sally att
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K081920