SIMPLEXA C. DIFFICILE UNIVERSAL DIRECT

• K Number: K113433
• Device Name: SIMPLEXA C. DIFFICILE UNIVERSAL DIRECT
• Manufacturer: FOCUS DIAGNOSTICS, INC.
• Date Cleared: 2012-04-04 ( 135 days)
• Product Code: OMN
• Regulation Number: 866.2660

Intended Use

The Focus Diagnostics Simplexa™ C. difficile Universal Direct is a real-time polymerase chain reaction (PCR) assay and is intended for use on the 3M Integrated Cycler instrument for the detection of toxigenic Clostridium difficile toxin B gene (tcdB) in liquid or unformed stool samples from individuals suspected of C. difficile infection. This test aids in the diagnosis of Clostridium difficile associated disease (CDAD).

Device Description

The test is a real-time polymerase chain reaction (PCR) amplification system that utilizes bifunctional fluorescent probe-primers for the detection of C. difficile in liquid or unformed stool. The Simplexa™ C. difficile Universal Direct kit contains primes, buffers and controls. The assay is composed of two principal steps: (1) Heat treatment of stool samples, (2) Amplification of the C. difficile DNA and internal control DNA using bi-functional fluorescent probe-primers together with reverse primers. The DNA internal control is used to monitor potential presence of PCR inhibitors. The assay targets a sequence which is in a well conserved region of C. difficile toxin B gene (tcdB).

Predicate Devices

K110012, K081920

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on standard PCR technology and analytical performance metrics, with no mention of AI or ML algorithms for data analysis or interpretation.

Therapeutic

No.
This device is a diagnostic test that detects the presence of a specific gene to aid in the diagnosis of C. difficile infection, rather than directly treating a condition.

Diagnostic

Yes
The "Intended Use / Indications for Use" section explicitly states that the device aids in the "diagnosis of Clostridium difficile associated disease (CDAD)."

SaMD (Software as a Medical Device)

No

The device description clearly states it is a real-time PCR amplification system and includes a kit with primers, buffers, and controls, which are physical components, not software.

IVD (In Vitro Diagnostic)

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

Here's why:

• Intended Use: The "Intended Use / Indications for Use" section explicitly states that the device is "intended for use... for the detection of toxigenic Clostridium difficile toxin B gene (tcdB) in liquid or unformed stool samples from individuals suspected of C. difficile infection." It also states that the test "aids in the diagnosis of Clostridium difficile associated disease (CDAD)." This clearly indicates that the device is used to examine specimens derived from the human body to provide information for the diagnosis of a disease.
• Device Description: The description details a "real-time polymerase chain reaction (PCR) amplification system" that analyzes stool samples to detect specific DNA sequences related to C. difficile. This is a common method used in in vitro diagnostics.
• Performance Studies: The document includes detailed performance studies (Reproducibility, Limit of Detection, Analytical Reactivity, Cross Reactivity, Interference, Clinical Studies) and key metrics (Sensitivity, Specificity), which are standard requirements for demonstrating the performance of an IVD.
• Predicate Devices: The mention of "Predicate Device(s)" with K numbers (K110012 and K081920) indicates that this device is being compared to other devices that have already been cleared as IVDs by regulatory bodies like the FDA.

All these points align with the definition and characteristics of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Focus Diagnostics Simplexa™ C. difficile Universal Direct is a real-time polymerase chain reaction (PCR) assay and is intended for use on the 3M Integrated Cycler instrument for the detection of toxigenic Clostridium difficile toxin B gene (tcdB) in liquid or unformed stool samples from individuals suspected of C. difficile infection. This test aids in the diagnosis of Clostridium difficile associated disease (CDAD).

Product codes

OMN

Device Description

The test is a real-time polymerase chain reaction (PCR) amplification system that utilizes bifunctional fluorescent probe-primers for the detection of C. difficile in liquid or unformed stool. The Simplexa™ C. difficile Universal Direct kit contains primes, buffers and controls. The assay is composed of two principal steps: (1) Heat treatment of stool samples, (2) Amplification of the C. difficile DNA and internal control DNA using bi-functional fluorescent probe-primers together with reverse primers. The DNA internal control is used to monitor potential presence of PCR inhibitors. The assay targets a sequence which is in a well conserved region of the C. difficile toxin B gene (tcdB).

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Stool samples

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

Three external testing sites, located on the East Coast of the US, participated in the Clinical Agreement Study, Site 1 prospectively collected fresh specimens and tested them with the Simplexa™ C. difficile Universal Direct Kit. A frozen aliquot was sent to Site 2 for toxigenic culture. Site 2 also prospectively collected fresh specimens and tested them with the Simplexa™ C. difficile Universal Direct Kit. A frozen aliquot was later set up for toxigenic culture. Site 3 performed Simplexa™ C. difficile testing on clinical specimens prospectively collected from the West Coast of the US and Upper Mid-West of the US. A frozen aliquot of each of these specimens was sent to Site 2 for toxigenic culture. Site 2 conducted all direct and enriched toxigenic culture testing for all specimens.

A total of 970 prospectively collected stool specimens were obtained from patients with signs and symptoms of C. difficile infection. Demographic information, including age, gender and the geographic collection were obtained.

Reference Method: Direct Culture + Toxin Assay and Enriched Culture + Toxin Assay.

Summary of Performance Studies

Clinical Study Type: Clinical Agreement Study
Sample Size: 969 clinical specimens (one sample was inadvertently missed from being cultured)

Key Results:
Sensitivity (versus Direct Culture + Toxin Assay): 90.1% (118/131) with 95% CI: 83.8-94.1%
Specificity (versus Direct Culture + Toxin Assay): 93.0% (779/838) with 95% CI: 91.0-94.5%

Sensitivity (versus Enriched Culture + Toxin Assay): 79.6% (144/181) with 95% CI: 73.1-84.8%
Specificity (versus Enriched Culture + Toxin Assay): 95.8% (755/788) with 95% CI: 94.2-97.0%

Reproducibility:
Low Positive: 100% (90/90)
Medium Positive: 100% (89/89)
Positive Control (PC): 100% (90/90)
High Negative: 98.9% (89/90)
No Template Control (NTC): 98.9% (89/90)
Total Agreement: 99.6% (447/449)

Limit of Detection (LoD):
ATCC 43255: 560.7 CFU/mL or 1.12 CFU/PCR
NAP 1A: 76.3 CFU/mL or 0.15 CFU/PCR

Analytical Reactivity: 20 different C. difficile strains tested in triplicate, all detected (3/3 for each strain).

Cross Reactivity: 119 potential cross-reactants tested, no cross-reactivity observed for any.

Interference: 21 potentially interfering substances spiked into low positive C. difficile stool-TE buffer matrix, no interference observed for C. difficile Strain ATCC43255 (3/3 detected) and C. difficile Strain - NAP 1A (3/3 detected), with some exceptions noted for specific interferents (Laxative generic and Whole blood).

Key Metrics

Sensitivity (versus Direct Culture + Toxin Assay): 90.1%
Specificity (versus Direct Culture + Toxin Assay): 93.0%
Sensitivity (versus Enriched Culture + Toxin Assay): 79.6%
Specificity (versus Enriched Culture + Toxin Assay): 95.8%

Predicate Device(s)

K110012, K081920

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

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

APR - 4 2012

Image /page/0/Picture/1 description: The image shows the logo for Focus Diagnostics. The logo consists of the word "FOCUS" in bold, sans-serif font, with the word "Diagnostics" in a smaller, non-bold font underneath. To the left of the word "FOCUS" is a curved, black shape that resembles a check mark or a stylized crescent.

510(k) Summarv Simplexa™ C. difficile Universal Direct Catalog No. MOL2975 Prepared Date: April 5, 2012 Page 1 of 11

K113433

| Applicant | Focus Diagnostics, Inc.
11331 Valley View Street
Cypress, California 90630
USA |
|--------------------------------|-----------------------------------------------------------------------------------------|
| Establishment Registration No. | 2023365 |
| Contact Person | Sharon Young
Tel [phone]
Fax [phone] |
| Summary Date | April 5, 2012 |
| Proprietary Name | SimplexaTM C. difficile Universal Direct |
| Generic Name | C.difficile nucleic acid |
| Classification | Class I |
| Predicate Devices | illumigeneTM C. difficile (K110012)
BD GeneOhmTM Cdiff (K081920) |

Intended Use

The Focus Diagnostics Simplexa™ C. difficile Universal Direct is a real-time polymerase chain reaction (PCR) assay and is intended for use on the 3M Integrated Cycler instrument for the detection of toxigenic Clostidium difficile toxin B gene (tcdB) in liquid or unformed stool samples from individuals suspected of C. difficile infection. This test aids in the diagnosis of Clostridium difficile associated disease (CDAD).

Device Description

The test is a real-time polymerase chain reaction (PCR) amplification system that utilizes bifunctional fluorescent probe-primers for the detection of C. difficile in liquid or unformed stool. The Simplexa™ C. difficile Universal Direct kit contains primes, buffers and controls. The assay is composed of two principal steps: (1) Heat treatment of stool samples, (2) Amplification of the C. difficile DNA and internal control DNA using bi-functional fluorescent probe-primers together with reverse primers. The DNA internal control is used to monitor potential presence of PCR inhibitors. The assay targets a sequence which is in a well conserved region of C. difficile toxin B gene (tcdB).

Trade Name / Method	510(k) submitter	510(k) number	Decision Date	Panel	Product Code(s)
illumigene™ C. difficile	MERIDIAN BIOSCIENCE, INC	K110012	02/24/2011	Microbiology	OMN
BD GeneOhm™ Cdiff Assay	BD DIAGNOSTICS (GENEOHM SCIENCES, INC.)	K081920	12/19/2008	Microbiology	LLH

Predicate Device Information

1

Image /page/1/Picture/0 description: The image shows the logo for Focus Diagnostics. The word "FOCUS" is in large, bold, sans-serif font. A curved line is to the left of the word. Below the word "FOCUS" is the word "Diagnostics" in a smaller font with a line above it.

K113433 Simplexa™ C. difficile Universal Direct Catalog No. Mol Prepared Date: April 5, 2012 . Page 2 of 11

Comparison to Predicate

Item	Device	Predicate 1	Predicate 2
Name	Simplexa™ C. difficile
Universal Direct	illumigene™ C. difficile	BD GeneOhm™ Cdiff
Intended Use	The Focus Diagnostics
Simplexa™ C. difficile
Universal Direct is a real-
time polymerase chain
reaction (PCR) assay and is
intended for use on the 3M
Integrated Cycler instrument
for the detection of toxigenic
Clostridium difficile toxin B
gene (tcdB) in liquid or
unformed stool samples
from individuals suspected
of C. difficile infection. This
test aids in the diagnosis of
Clostridium difficile
associated disease (CDAD).	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. The 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.	The BD GeneOhm™ C diff
Assay is a rapid in vitro
diagnostic test for the direct,
qualitative detection of C.
difficile toxin B gene (tcdB)
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.
Assay Targets	C. difficile toxin B gene
(tcdB)	PaLoc region (encoding
tcdA and tcdB)	C. difficile toxin B gene
(tcdB)
Item	Device	Predicate 1	Predicate 2
Name	Simplexa™ C. difficile
Universal Direct	illumigene™ C. difficile	BD GeneOhm™ Cdiff
Sample Types	Liquid or unformed stool	Unformed human stool	Liquid or soft stool specimen
Extraction Methods	Off-board 10 minute
preheating step.	Off-board 10 minute
preheating step, followed by
vortexing.	5 minutes of vortexing,
sample centrifugation,
followed by a 5 minute
heating step.
Assay Methodology	The Simplexa C. difficile Universal Direct assay incorporates direct, qualitative detection of toxigenic C. difficile DNA from clinical specimens in human stool specimens using the 3M Integrated Cycler. The assay utilizes real-time PCR technology with fluorescently labeled,	The assay is performed on the illumipro-10, and is a qualitative assay for direct detection of toxigenic C. difficile in human stool specimens. It utilizes loop-mediated isothermal DNA amplification technology to detect the pathogenicity locus (PaLoc) of toxigenic C. difficile . The PaLoc is a	The BD GeneOhm Cdiff assay is used for qualitative detection of C. difficile toxin B gene (tcdB) in human liquid or soft stool, using the Cepheid SmartCycler. The test uses real-time PCR for the amplification of specific targets which are detected by fluorogenic target-specific hybridization probes
	bi-functional probe-primer that amplify and detect a conserved region of the toxin B (tcdB) gene.	gene segment present in all known toxigenic C. difficile strains, and it codes for both the Toxin A gene (tcdA) and the Toxin B gene (tcdB).	(molecular beacons). The amplification, detection and interpretation of the signals are done automatically by the Cepheid SmartCycler software.
Detection Techniques	Real time PCR with bi-functional fluorescent probe-primers using the 3M Integrated Cycler.	Isothermal loop-mediated amplification technology, with detection of light transmission change based on magnesium pyrophosphate precipitation.	Real time PCR with molecular beacons using the Cepheid SmartCycler.
Reference Method	Toxigenic Culture	Cytotoxigenic Bacterial
Culture	Cytotoxicity Assay
Limit of Detection	ATCC 43255
560.7 CFU/mL or 1.12
CFU/PCR
NAP 1A 76.3 CFU/mL or
0.15 CFU/PCR	VPI 10463, 4CFU/test
2007431, 32 CFU/test
CFI, 64 CFU/test
2006240, 32 CFU/test
B18, 64 CFU/test
2007858, 32 CFU/test
8864, 64 CFU/test	ATCC 43255
10 DNA copies/reaction,
4 CFU/reaction
Reproducibility	Low Positive 100% (90/90)
Medium Positive 100%
(89/89)
High Negative 98.9%
(89/90)
No Template Control (NTC)
98.9% (89/90)	Low Positive 100% (90/90)
Positive 100% (60/60)
High Negative 91% (82/90)
Negative 100% (59/59)	Low Positive 96.7% (87/90)
Moderate Positive 100%
(90/90)
Negative 100% (90/90)
Additional reproducibility
using dilutions of high
negative at 1:100 dilution
80% (72/90) and 1:10
dilution 23.3% (21/90)

2

Image /page/2/Picture/0 description: The image shows the logo for Focus Diagnostics. The logo features the word "FOCUS" in bold, sans-serif font, with a curved, crescent-shaped graphic to the left. Below the word "FOCUS" is the word "Diagnostics" in a smaller, sans-serif font, underlined with a thin line.

.. "

Simplexa™ C. difficile Universal Direct Catalog No. Mot Prepared Date: April 5, 2012 . Page 3 of 11

..

. . .

:

:

'

3

Image /page/3/Picture/0 description: The image shows the alphanumeric string "K113433" in a simple, sans-serif font. The characters are uniformly sized and spaced, with a clear distinction between the letter "K" and the numerical digits. The string appears to be a code or identifier, possibly a serial number or product key.

Image /page/3/Picture/12 description: The image shows the logo for Focus Diagnostics. The logo consists of a stylized black swoosh on the left, followed by the word "FOCUS" in bold, sans-serif font. Below the word "FOCUS" is the word "Diagnostics" in a smaller, less bold font, underlined with a thin black line.

510(k) Summarv Simplexa™ C. difficile Universal Direct Catalog No. MOL2975 Prepared Date: April 5, 2012 Page 4 of 11

REPRODUCIBILITY

Three investigators assessed the device's inter-laboratory reproducibility and interlintra-assay reproducibility. Each of the three sites used the same panel, which consisted of contrived samples in stool-TE buffer matrix spiked with C. difficile bacterial stock. The panel included high negative, and medium positive samples. Each site utilized at least two testing operators and one lot of Simplexa™ C.difficile Universal Direct kit across five days. On each day two runs were performed, one by each operator. A summary of the results are shown in Table 3.

Table 3. Reproducibility Results
----------------------------------	--

Sample	Site 1			Site 2			Site 3			Total Agreement with Expected Results	95% CI
	Agreement with Expected Results	Avg. Ct	Total %CV	Agreement with Expected Results	Avg. Ct	Total %CV	Agreement with Expected Results	Avg. Ct	Total %CV
Low Positive	30/30	35.20	1.64	30/30	35.26	1.30	30/30	35.30	2.04	100% (90/90)	95.9% - 100.0%
Medium Positive1	29/29	32.71	0.82	30/30	32.60	1.07	30/30	32.65	0.77	100% (89/89)	95.9% - 100.0%
Positive Control (PC)2	30/30	32.55	1.11	29/29	32.13	0.87	31/31	32.33	0.63	100% (90/90)	95.9% - 100.0%
High Negative	29/30			30/30			30/30			98.9% (89/90)	94.0% - 99.8%
No Template Control (NTC)3	30/30			30/30			29/30			98.9% (89/90)	94.0% - 99.8%
Total Agreement	148/149 (99.3%)			149/149 (100.0%)			150/151 (99.3%)			447/449 (99.6%)	98.4% - 99.9%

I one replicate was declared "invalid" based on the site operator discretion. It was "Not Detected".

4 one replicate was "Invalid" at Site 2 and additional replicate was tested in Run-1, Day-1 at Site 3 because the site had thought that one of the three replicates had a 'bubble' and therefore as a precaution loaded an additional replicate at the run. One replicate of the NTC is "Detected" and may be attributed to possible contamination due to handling.

Note: Two samples - "NTC" and "High Negative" were excluded from reporting Quantitative Reproducibility Results.

LIMIT OF DETECTION

The Limit of Detection (LoD) was determined for the Simplexa™ C. difficile Universal Direct assay by performing limiting dilution studies using bacterial stocks for two C. difficile bacterial strains (ATCC 43255 and NAP 1A) were cultured and quantified. The LoD was determined using one lot of the Simplexa™ C. difficile Universal Direct Kit. Tentative LoD was determined using three replicates in screening followed by confirmation using twenty replicates. LoD was determined to be 560.7 CFU/mL or 1.12 CFU/PCR for strain ATCC 43255 and 76.3 CFU/mL or 0.15 CFU/PCR for strain NAP 1A.

4

Image /page/4/Picture/0 description: The image shows the alphanumeric string "K113433" in a clear, sans-serif font. The characters are uniformly sized and spaced, making the string easily readable. The black text stands out against the white background, enhancing its visibility.

Image /page/4/Picture/1 description: The image shows the logo for Focus Diagnostics. The logo features a stylized crescent shape on the left, followed by the word "FOCUS" in bold, sans-serif font. Below "FOCUS" is the word "Diagnostics", in a smaller, sans-serif font, with a line above it.

510(k) Summary Simplexa™ C. difficile Universal Direct Catalog No. MOL2975 Prepared Date: April 5, 2012 Page 5 of 11

ANALYTICAL REACTIVITY

Analytical reactivity of additional strains of C. difficile was evaluated in negative stool-TE buffer matrix. Quantified bacterial material was spiked into the negative stool-TE buffer matrix at a single dilution. A total of 20 different strains were tested in triplicate. All of the tested strains were detected (Table 4).

| No. | Strain | Concentration
(cfu/mL) | Toxinotype | C.difficile Result
#Detected / #Total |
|-----|------------------------------|---------------------------|------------|------------------------------------------|
| 1 | ATCC 17857 (870) A+B+ | $1.12 x 10^3$ | 0 | 3/3 |
| 2 | ATCC 43594 (W1194) A+B+ | $1.12 x 10^3$ | 0 | 3/3 |
| 3 | ATCC 43596 (545) A+B+ | $1.12 x 10^3$ | 0 | 3/3 |
| 4 | ATCC 43597 A+B+ | $1.12 x 10^3$ | | 3/3 |
| 5 | ATCC 43598 (1470) A-B+ | $1.12 x 10^3$ | VIII | 3/3 |
| 6 | ATCC 43599 (2022) A+B+ | $1.12 x 10^3$ | 0 | 3/3 |
| 7 | ATCC 43600 (2149) A+B+ | $1.12 x 10^3$ | 0 | 3/3 |
| 8 | ATCC 51695 (BDMS 18 AN) A+B+ | $1.12 x 10^3$ | 0 | 3/3 |
| 9 | ATCC 700792 (14797-2) A+B+ | $1.12 x 10^3$ | 0 | 3/3 |
| 10 | ATCC 9689 (90556-M6S) A+B+ | $1.12 x 10^3$ | 0 | 3/3 |
| 11 | ATCC BAA-1382 (630) A+B+ | $1.12 x 10^3$ | 0 | 3/3 |
| 12 | ATCC BAA-1805 A+B+ | $1.12 x 10^3$ | III | 3/3 |
| 13 | BAA-1814 A+B+ | $1.12 x 10^3$ | XXII | 3/3 |
| 14 | BAA-1870 A+B+ | $1.12 x 10^3$ | III | 3/3 |
| 15 | BAA-1871 A+B+ | $1.12 x 10^3$ | 0 | 3/3 |
| 16 | BAA-1872 A+B+ | $1.12 x 10^3$ | 0 | 3/3 |
| 17 | BAA-1873 A+B+ | $1.12 x 10^3$ | 0 | 3/3 |
| 18 | BAA-1874 A+B+ | $1.12 x 10^3$ | 0 | 3/3 |
| 19 | BAA-1875 A+B+ | $1.12 x 10^3$ | V | 3/3 |
| 20 | CCUG 8864 A-B+ | $1.12 x 10^3$ | X | 3/3 |

Table 4. Analytical Reactivity Results for C. difficile strains

CROSS REACTIVITY

Analytical specificity for various possible cross-reactants was performed. A total of 119 potential cross-reactants were tested. No cross reactivity was observed (Table 5).

Table 5. Cross Reactivity Results

No.	Cross Reactant	Concentration	Result
1	Abiotrophia defective	$1.00 \times 10^6$ cfu/mL	No Cross Reactivity Observed
2	Acinetobacter baumanii	$1.00 \times 10^6$ cfu/mL	No Cross Reactivity Observed
3	Acinetobacter Iwofii	$1.00 \times 10^6$ cfu/mL	No Cross Reactivity Observed
4	Adenovirus 40	$1.00 \times 10^5$ TCID50/mL	No Cross Reactivity Observed
		Tested Cross-Reactants
No.	Cross Reactant	Concentration	Result
5	Aeromonas hydrophila	1.00 x 106 cfu/mL	No Cross Reactivity Observed
6	Alcaligenes faecalis subsp. Faecalis	1.00 x 106 cfu/mL	No Cross Reactivity Observed
7	Anaerococcus tetradius	1.00 x 106 cfu/mL	No Cross Reactivity Observed
8	Bacillus cereus	1.00 x 106 cfu/mL	No Cross Reactivity Observed
9	Bacteroides caccae	1.00 x 106 cfu/mL	No Cross Reactivity Observed
10	Bacteroides merdae	1.00 x 106 cfu/mL	No Cross Reactivity Observed
11	Bacteroides stercoris	1.00 x 106 cfu/mL	No Cross Reactivity Observed
12	Bifidobacterium adolescentis	1.00 x 106 cfu/mL	No Cross Reactivity Observed
13	Bifidobacterium longum	1.00 x 106 cfu/mL	No Cross Reactivity Observed
14	Campylobacter coli	1.00 x 106 cfu/mL	No Cross Reactivity Observed
15	Campylobacter jejuni	1.00 x 106 cfu/mL	No Cross Reactivity Observed
16	Candida albicans	1.00 x 106 cfu/mL	No Cross Reactivity Observed
17	Candida catenulate	1.00 × 106 cfu/mL	No Cross Reactivity Observed
18	Cedecea davisae	1.00 x 106 cfu/mL	No Cross Reactivity Observed
19	Chlamydia trachomatis	1.00 x 106 cfu/mL	No Cross Reactivity Observed
20	Citrobacter amalonaticus	1.00 x 106 cfu/mL	No Cross Reactivity Observed
21	Citrobacter freundii	1.00 x 106 cfu/mL	No Cross Reactivity Observed
22	Citrobacter koseri	1.00 x 106 cfu/mL	No Cross Reactivity Observed
23	Citrobacter sedlakii	1.00 x 106 cfu/mL	No Cross Reactivity Observed
24	Clostridium beijerinckii	1.00 x 106 cfu/mL	No Cross Reactivity Observed
25	Clostridium bifermentans	1.00 x 106 cfu/mL	No Cross Reactivity Observed
26	Clostridium bolteae	1.00 x 106 cfu/mL	No Cross Reactivity Observed
27	Clostridium butyricum	6.80 x 105 cfu/mL	No Cross Reactivity Observed
28	Clostridium chauvoei	1.00 x 106 cfu/mL	No Cross Reactivity Observed
29	Clostridium difficile non-toxigenic ATCC
43593	1.00 x 106 cfu/mL	No Cross Reactivity Observed
30	Clostridium difficile non-toxigenic
ATCC43601	1.00 x 106 cfu/mL	No Cross Reactivity Observed
31	Clostridium fallax	1.00 x 106 cfu/mL	No Cross Reactivity Observed
32	Clostridium histolyticum	1.00 x 106 cfu/mL	No Cross Reactivity Observed
33	Clostridium innocuum	1.00 x 106 cfu/mL	No Cross Reactivity Observed
34	Clostridium methylpentosum	1.00 x 106 cfu/mL	No Cross Reactivity Observed
35	Clostridium nexile	6.90 x 105 cfu/mL	No Cross Reactivity Observed
36	Clostridium novyi	8.90 x 105 cfu/mL	No Cross Reactivity Observed
37	Clostridium paraputrificum	1.00 x 106 cfu/mL	No Cross Reactivity Observed
38	Clostridium perfringens	6.70 x 105 cfu/mL	No Cross Reactivity Observed
39	Clostridium ramosum	1.00 x 106 cfu/mL	No Cross Reactivity Observed
40	Clostridium scindens	1.00 x 106 cfu/mL	No Cross Reactivity Observed
41	Clostridium sepiticum	1.00 x 106 cfu/mL	No Cross Reactivity Observed
No.	Cross Reactant	Concentration	Result
42	Clostridium sordellii	1.00 x 106 cfu/mL	No Cross Reactivity Observed
43	Clostridium sphenoides	1.00 x 106 cfu/mL	No Cross Reactivity Observed
44	Clostridium sporogenes	1.00 x 106 cfu/mL	No Cross Reactivity Observed
45	Clostridium symbiosum	1.00 x 106 cfu/mL	No Cross Reactivity Observed
46	Clostridium terdium	1.00 x 106 cfu/mL	No Cross Reactivity Observed
47	Clostridium tetani	1.00 x 106 cfu/mL	No Cross Reactivity Observed
48	Collinsella aerofaciens	8.60 x 105 cfu/mL	No Cross Reactivity Observed
49	Corynebacterium genitalium	1.00 x 106 cfu/mL	No Cross Reactivity Observed
50	Coxsackie virus A16	1.00 × 105 TCID50/mL	No Cross Reactivity Observed
51	Cytomegalovirus AD-169	1.00 × 105 TCID50/mL	No Cross Reactivity Observed
52	Desulfovibrio piger	1.00 x 106 cfu/mL	No Cross Reactivity Observed
53	Echovirus 9	1.00 × 105 TCID50/mL	No Cross Reactivity Observed
54	Edwardsiella tarda	1.00 x 106 cfu/mL	No Cross Reactivity Observed
55	Eggerthellalenta	1.00 x 106 cfu/mL	No Cross Reactivity Observed
56	Enterobacter aerogenes	1.00 x 106 cfu/mL	No Cross Reactivity Observed
57	Enterobacter cloacae	1.00 x 106 cfu/mL	No Cross Reactivity Observed
58	Enterococcu raffinosus	1.00 x 106 cfu/mL	No Cross Reactivity Observed
59	Enterococcus casseliflavus	1.00 x 106 cfu/mL	No Cross Reactivity Observed
60	Enterococcus cecorum	1.00 x 106 cfu/mL	No Cross Reactivity Observed
61	Enterococcus dispar	1.00 x 106 cfu/mL	No Cross Reactivity Observed
62	Enterococcus hirae	1.00 x 106 cfu/mL	No Cross Reactivity Observed
63	Enterococcusfaecalis vanB	1.00 x 106 cfu/mL	No Cross Reactivity Observed
64	Enterococcusfaecium vanA	1.00 x 106 cfu/mL	No Cross Reactivity Observed
65	Enterococcusgallinarum vanC	1.00 x 106 cfu/mL	No Cross Reactivity Observed
66	Enterovirus 71	5.01 × 104 TCID50/mL	No Cross Reactivity Observed
67	Escherichia coli	1.00 x 106 cfu/mL	No Cross Reactivity Observed
68	Escherichia fergusonii	1.00 x 106 cfu/mL	No Cross Reactivity Observed
69	Escherichia hermannii	1.00 x 106 cfu/mL	No Cross Reactivity Observed
70	Fusobacterium varium	1.00 x 106 cfu/mL	No Cross Reactivity Observed
71	Gardnerella vaginalis	1.00 x 106 cfu/mL	No Cross Reactivity Observed
72	Gemella morbillorum	1.00 x 106 cfu/mL	No Cross Reactivity Observed
73	Hafnia alvei	1.00 x 106 cfu/mL	No Cross Reactivity Observed
74	Helicobacter pylori	1.00 x 106 cfu/mL	No Cross Reactivity Observed
75	Homo sapiens	3.07 pg/mL	No Cross Reactivity Observed
76	Klebsiella oxytoca	1.00 x 106 cfu/mL	No Cross Reactivity Observed
77	Klebsiella pneumoniae subsp.
Pneumoniae	1.00 x 106 cfu/mL	No Cross Reactivity Observed
78	Lactobacillus acidophilus	1.00 x 106 cfu/mL	No Cross Reactivity Observed
79	Lactobacillus reuteri	1.00 x 106 cfu/mL	No Cross Reactivity Observed
	Tested Cross-Reactants
No.	Cross Reactant	Concentration	Result
80	Lactococcus lactis	$1.00 \times 10^6$ cfu/mL	No Cross Reactivity Observed
81	Leminorela grimontii	$1.00 \times 10^6$ cfu/mL	No Cross Reactivity Observed
82	Listeria grayi	$1.00 \times 10^6$ cfu/mL	No Cross Reactivity Observed
83	Listeria innocua	$1.00 \times 10^6$ cfu/mL	No Cross Reactivity Observed
84	Listeria monocytogenes	$1.00 \times 10^6$ cfu/mL	No Cross Reactivity Observed
85	Norovirus Group I (recombinant)	$8.13 \times 10^4$ TCID50/mL	No Cross Reactivity Observed
86	Peptoniphilus asaccharolyticus	$1.00 \times 10^6$ cfu/mL	No Cross Reactivity Observed
87	Peptostreptococcus anaerobius	$1.00 \times 10^6$ cfu/mL	No Cross Reactivity Observed
88	Plesiomonas shigelloides	$1.00 \times 10^6$ cfu/mL	No Cross Reactivity Observed
89	Porphyromaonas asaccharolytica	$1.00 \times 10^6$ cfu/mL	No Cross Reactivity Observed
90	Prevotella melaninogenica	$1.00 \times 10^6$ cfu/mL	No Cross Reactivity Observed
91	Proteus mirabilis	$1.00 \times 10^6$ cfu/mL	No Cross Reactivity Observed
92	Proteus penneri	$1.00 \times 10^6$ cfu/mL	No Cross Reactivity Observed
93	Providencia alcalifaciens	$1.00 \times 10^6$ cfu/mL	No Cross Reactivity Observed
94	Providencia rettgeri	$1.00 \times 10^6$ cfu/mL	No Cross Reactivity Observed
95	Providencia stuartli	$1.00 \times 10^6$ cfu/mL	No Cross Reactivity Observed
96	Pseudomonas aeruginosa	$1.00 \times 10^6$ cfu/mL	No Cross Reactivity Observed
97	Pseudomonas putida	$1.00 \times 10^6$ cfu/mL	No Cross Reactivity Observed
98	Rotavirus, Strain Wa	$1.00 \times 10^5$ TCID50/mL	No Cross Reactivity Observed
99	Salmonella enterica subsp. Arizonae
(formerly Choleraesuis arizonae)	$1.00 \times 10^6$ cfu/mL	No Cross Reactivity Observed
100	Salmonella enterica subsp. Choleraesuis	$1.00 \times 10^6$ cfu/mL	No Cross Reactivity Observed
101	Salmonella enterica subsp. Enterica
serovar Typhimurium	$1.00 \times 10^6$ cfu/mL	No Cross Reactivity Observed
102	Serratia liquefaciens	$1.00 \times 10^6$ cfu/mL	No Cross Reactivity Observed
103	Serratia marcescens	$1.00 \times 10^6$ cfu/mL	No Cross Reactivity Observed
104	Shigella boydii	$1.00 \times 10^6$ cfu/mL	No Cross Reactivity Observed
105	Shigella dysenteriae	$1.00 \times 10^6$ cfu/mL	No Cross Reactivity Observed
106	Shigella sonnei	$1.00 \times 10^6$ cfu/mL	No Cross Reactivity Observed
107	Staphylococcus aureus	$1.00 \times 10^6$ cfu/mL	No Cross Reactivity Observed
108	Staphylococcus epidermidis	$1.00 \times 10^6$ cfu/mL	No Cross Reactivity Observed
109	Stenotrophomonas maltophilia	$1.00 \times 10^6$ cfu/mL	No Cross Reactivity Observed
110	Streptococcus agalactiae	$1.00 \times 10^6$ cfu/mL	No Cross Reactivity Observed
111	Streptococcus dysgalactiae	$1.00 \times 10^6$ cfu/mL	No Cross Reactivity Observed
112	Streptococcus intermedius	$1.00 \times 10^6$ cfu/mL	No Cross Reactivity Observed
113	Streptococcus uberis	$1.00 \times 10^6$ cfu/mL	No Cross Reactivity Observed
114	Trabulsiella guamensis	$1.00 \times 10^6$ cfu/mL	No Cross Reactivity Observed
115	Veillonella parvula	$1.00 \times 10^6$ cfu/mL	No Cross Reactivity Observed
116	Vibrio cholerae	$4.10 \times 10^3$ pg/mL	No Cross Reactivity Observed
Tested Cross-Reactants
No.	Cross Reactant	Concentration	Result
117	Vibrio parahaemolyticus	$1.00 \times 10^6$ cfu/mL	No Cross Reactivity Observed
118	Yersinia bercovieri	$1.00 \times 10^6$ cfu/mL	No Cross Reactivity Observed
119	Yersinia rohdei	$1.00 \times 10^6$ cfu/mL	No Cross Reactivity Observed

5

Image /page/5/Picture/0 description: The image shows the logo for Focus Diagnostics. The logo has a black swoosh on the left side of the word "FOCUS", which is written in all capital letters. Below the word "FOCUS" is the word "Diagnostics".

Simplexa™ C. difficile Universal Direct Catalog No. MOL2375
Simplexa™ C. difficile Universal Direct Catalog No. MOL2375
Page 6 of 11

6

Image /page/6/Picture/0 description: The image shows the logo for Focus Diagnostics. The logo consists of the word "FOCUS" in bold, sans-serif font, with a curved, black shape to the left of the word. Below the word "FOCUS" is the word "Diagnostics" in a smaller, sans-serif font. The word "Diagnostics" is underlined.

Simplexa™ C. difficile Universal Direct Catalog No. Mol Prepared Date: April 5, 2012 Page 7 of 11

7

Image /page/7/Picture/0 description: The image shows the logo for Focus Diagnostics. The word "FOCUS" is in large, bold, sans-serif font. A curved, black shape is to the left of the word. Below the word "FOCUS" is the word "Diagnostics" in a smaller, sans-serif font, with a line above it.

Simplexa™ C. difficile Universal Direct Catalog No. MOL2307
Simplexa™ C. difficile Universal Direct Catalog No. MOL22972 Page 8 of 11 ·

8

Image /page/8/Picture/0 description: The image shows the logo for Focus Diagnostics. The logo features a stylized, curved shape on the left, resembling a check mark or a swoosh. To the right of this shape is the word "FOCUS" in bold, sans-serif capital letters. Below "FOCUS" is the word "Diagnostics" in a smaller, sans-serif font, underlined.

113433

510(k) Summary Simplexa™ C. difficile Universal Direct Catalog No. MOL2975 Prepared Date: April 5, 2012 Page 9 of 11

baseline (un-spiked) sample.

2 Each replicate of all 119 cross-reactants and baseline samples were "Not Detected".

INTERFERENCE

The performance of this assay was evaluated with potentially interfering substances that may be present in stool specimens at the concentrations indicated in Table 6 below. A total of 21 potentially interfering substances were spiked into a low positive C. difficile stool-TE buffer matrix and tested. No interference was observed.

Table 6. Summary of Interfering Substances and Testing Results for two C. difficile strains

| Interferents | Active Ingredient | Interferent
Concentration | Detected/Total | |
|------------------------------|--------------------------------------------------|------------------------------|------------------------------------|---------------------------------|
| | | | C. difficile Strain -
ATCC43255 | C. difficile Strain - NAP
1A |
| 1% Hydrocortisone Cream | Hydrocortisone | 2% (w/v) | 3/3 | 3/3 |
| Aleve | Naproxen | 14 mg/ml | 3/3 | 3/3 |
| Antacid and Anti-gas generic | Aluminum
Hydroxide,
Magnesium
Hydroxide | 0.1 mg/ml | 3/3 | 3/3 |
| Antacid Generic | Calcium
Carbonate | 0.1 mg/ml | 3/3 | 3/3 |
| Barium sulfate | Barium sulfate | 5 mg/ml | 3/3 | 3/3 |
| Fleet | Mineral Oil | 2% (v/v) | 3/3 | 3/3 |
| Imodium AD | Loperamide | 0.005 mg/ml | 3/3 | 3/3 |
| KY Jelly | Glycerin | 2%(w/v) | 3/3 | 3/3 |
| Laxative generic | Sennosides | 0.1 mg/ml | 5/5* | 3/3 |
| Metronidazole | Metronidazole | 14 mg/ml | 3/3 | 3/3 |
| Milk of Magnesia | Magnesium
Hydroxide | 0.2 mg/ml | 3/3 | 3/3 |
| Moist towelettes generic | Benzalkonium
Chloride | 10%(v/v) | 3/3 | 3/3 |
| Mucin | Mucin | 3 mg/ml | 3/3 | 3/3 |
| Nystatin | Nystatin | 10000 USP
units/ml | 3/3 | 3/3 |
| Palmitic acid | Palmitic acid | 2 mg/ml | 3/3 | 3/3 |
| Pepto-Bismol | Bismuth
Subsalicylate | 0.175 mg/ml | 3/3 | 3/3 |
| Preparation H | Phenylephrine | 2% (w/v) | 3/3 | 3/3 |

9

Image /page/9/Picture/0 description: The image shows the logo for Focus Diagnostics. The logo features the word "FOCUS" in large, bold, sans-serif font. A curved, swooping shape is positioned to the left of the word, visually emphasizing the concept of focus. Below the word "FOCUS" is the word "Diagnostics" in a smaller font size.

13433 510(k) Summarv Simplexa™ C. difficile Universal Direct Catalog No. MOL2975 Prepared Date: April 5, 2012 Page 10 of 11

| ్లో
Interferents
12 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 | Active Ingredient | Interferent
Concentration
: > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > | Detected/Total | |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------|----------------------------------|
| | | | C. difficile Strain -
ATCC43255 | "C. difficile Strain - NAP
14 |
| Stearic acid | Stearic Acid | 4 mg/ml | 3/3 | 3/3 |
| Trojan with nonoxynol-9 | Nonoxynol-9 | 1.4 mg/ml | ર્ડાંક | ર્ડારે |
| Vancomycin | Vancomycin | 1.4 mg/ml | રાદિર | 3/3 |
| Whole blood | Whole blood | 3% | રીકે | 718 ** |

*One replicate reported as "Invalid" due to IC failure in initial run of three replicates reported as "Detected" in repeat run.

**One replicate reported as "Not Delected" in intilal run of three replicates reported as "Detected" in repeat run.

CLINICAL STUDIES

Three external testing sites, located on the East Coast of the US, participated in the Clinical Agreement Study, Site 1 prospectively collected fresh specimens and tested them with the Simplexa™ C. difficile Universal Direct Kit. A frozen aliquot was sent to Site 2 for toxigenic culture. Site 2 also prospectively collected fresh specimens and tested them with the Simplexa™ C. difficile Universal Direct Kit. A frozen aliquot was later set up for toxigenic culture. Site 3 performed Simplexa™ C. difficile testing on clinical specimens prospectively collected from the West Coast of the US and Upper Mid-West of the US. A frozen aliquot of each of these specimens was sent to Site 2 for toxigenic culture. Site 2 conducted all direct and enriched toxigenic culture testing for all specimens.

For clinical specimens tested at Site 1, results were also generated using an FDA cleared molecular assay. Similarly, for clinical specimens tested at Site 2, results were generated using an alternative FDA cleared molecular assay.

A total of 970 prospectively collected stool specimens were obtained from patients with signs and symptoms of C. difficile infection. Demographic information, including age, gender and the geographic collection were obtained.

Clinical Agreement summary results are presented in Table 7 and Table 8 below.

Table 7. Simplexa™ C. difficile Universal Direct Kit versus Direct Toxigenic Culture Method

	Reference Method: (Direct Culture + Toxin Assay)
Simplexa™ C. difficile Universal Direct Kit,	Detected	Not Detected	Total
Detected	118	59	177
Not Detected	13	779	792
Total	131	838	969
Sensitivity	90.1%(118/131)
95% CI:83.8-94.1%
Specificity	93.0%(779/838)
95% CI:91.0-94.5%

10

Image /page/10/Picture/0 description: The image shows the logo for Focus Diagnostics. The logo features the word "FOCUS" in large, bold, sans-serif font. Below the word "FOCUS" is the word "Diagnostics" in a smaller, sans-serif font with a line above it. To the left of the word "FOCUS" is a curved, black shape that resembles a check mark.

510(k) Summary Simplexa™ C. difficile Universal Direct Catalog No. MOL2975 Prepared Date: April 5, 2012 Page 11 of 11

	Reference Method: (Enriched Culture + Toxin Assay)
Simplexa™ C. difficile Universal Direct Kit	Detected	Not Detected	Total
Detected	144	33	177
Not Detected	37	755	792
Total	181	788	969
Sensitivity	79.6%(144/181)
95% CI:73.1-84.8%
Specificity	95.8%(755/788)
95% CI:94.2-97.0%

Table 8. Simplexa™ C. difficile Universal Direct Kit versus Enriched Toxigenic Culture Method

Note: One sample was inadvertently missed from being cultured.

In addition to the Simplexa™ C. difficile Universal Direct assay the specimens were tested using two different FDA-cleared assays: 402 samples were assayed using one FDA cleared molecular assay, and 305 samples were assayed using another FDA cleared molecular assay. The testing was performed at two different clinical sites. These two FDA cleared molecular assays were compared to direct and enriched toxigenic cultures.

In comparison to direct toxigenic culture, the sensitivity and specificity of the Simplexa™ C. difficile Universal Direct Assay were 90.1% (95% C):83.8-94.1%) and 93% (95% Cl:91-94.5%), respectively, as shown above. The sensitivities and specificities of the two FDA cleared molecular tests were 86.1% (95% Cl:76.3-92.3%) and 94.8% (95% Cl:91.9-96.8%) for the first molecular assay and 81.8% (95% Cl:65.6-91.4%) and 93% (95% CI:89.3-95.5%), for the second assay.

In comparison to enriched toxigenic culture, the sensitivity and specificity of the Simplexa™ C. difficile Universal Direct Assay were 79.6% (95% Cl:73.1-84.8%) and 95.8% (95% Cl:94.2-97%), respectively, as shown above. The sensitivities and specificities of the two FDA cleared molecular tests were 78.7% (95% Cl:69-85.9%) and 97.1% (95% Cl:94.6-98.5%) for the first molecular assay and 69.6% (95% Cl:56.7-80.1%) and 97.2% (95% CI:94.3-98.6%), for the second assay.

11

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/11/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized representation of an eagle or bird-like figure, with its wings spread and feathers depicted in a flowing, abstract manner.

Food and Drug Administration

10903 New Hampshire Avenue Silver Spring, MD 20993

FOCUS Diagnostics, Inc. c/o Ms. Sharon Young Sr. Regulatory Affairs Specialist 11331 Valley View Street Cypress, California 90630

APR'-4' 2012

Re: K113433

RT15153
Trade/Device Name: Simplexa™ C. difficile Universal Direct Regulation Number: 21 CFR 866.2660 Regulation Name : Microorganism differentiation and identification device Regulatory Class: Class I Product Code: OMN Dated: April 3, 2012 Received: April 4, 2012

Dear Ms. Young:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 10 use stated in the encloodiv) to togens and ment date of the Medical Device Amendments, or to commerce prior to May 20, 1978, in econdance with the provisions of the Federal Food, Drug, uevices that have been require approval of a premarket approval application (PMA). and Costine Hotel (11ct) that as novice, subject to the general controls provisions of the Act. The I ou may, therefore, market the devices, connects for annual registration, listing of general controls provisions of the 100 line 100 libeling, 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 (soo ao re) in the major regulations affecting your device can be found in Title 21, additional controls. Existing mayor regations of the 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 Please be advised that FDA s issualled of a succession in the requirements of the Act
that FDA has made a determination that your device complies with oneaning. You must that FDA has made a decierimiation administered by other Federal agencies. You must of any Pederal Slatures and regulations deminding, but not limited to: registration and listing (21
comply with all the Act's requirements, including, separting (regoring (re comply with all the Act 3 requirements and 809; medical device reporting (reporting of
CFR Part 807); labeling (21 CFR Parts 801 and monthschmonthotwring practice CFK Part 807), labeling (21 OF R Parts 802 and good manufacturing practice

12

Page 2 - Ms. Sharon Young

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 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 [phone]. 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 [phone] or (301) 796-7.100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Salyahopkins

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

510(k) Number (if known): K113433

Simplexa™ C. difficile Universal Direct Device Name:

Indications for Use:

The Focus Diagnostics Simplexa™ C. difficile Universal Direct is a real-time polymerase chain reaction (PCR) assay and is intended for use on the 3M Integrated Cycler instrument for the detection of toxigenic Clostridium difficile toxin B gene (tcdB) in liquid or unformed stool samples from individuals suspected of C. difficile infection. This test aids in the diagnosis of Clostridium difficile associated disease (CDAD).

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of InVitro Diagnostics (OIVD)

Raguele leat for. F. Pole

Division Sign-Off

Office of in Vitro Diagnostic Office of in Mills and Safety

510(k) 113433

Page 1 of 1