(135 days)
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 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).
1. Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria | Reported Performance (Simplexa™ C. difficile Universal Direct Kit) |
|---|---|---|
| Reproducibility | ||
| Low Positive | 100% agreement expected | 100% (90/90) |
| Medium Positive | 100% agreement expected | 100% (89/89) |
| Positive Control | 100% agreement expected | 100% (90/90) |
| High Negative | >90% agreement expected | 98.9% (89/90) |
| No Template Control (NTC) | >90% agreement expected | 98.9% (89/90) |
| Limit of Detection (LoD) | Not explicitly stated as "acceptance criteria" but determined via study | 560.7 CFU/mL (1.12 CFU/PCR) for ATCC 43255, 76.3 CFU/mL (0.15 CFU/PCR) for NAP 1A |
| Analytical Reactivity | 100% detection of tested strains | 100% (All 20 tested strains detected 3/3 replicates) |
| Cross-Reactivity | No cross-reactivity expected | No cross-reactivity observed (119 potential cross-reactants) |
| Interference | No interference expected | No interference observed (21 potentially interfering substances) |
| Clinical Sensitivity | Not explicitly stated as "acceptance criteria" but compared to predicate devices | Compared to Direct Toxigenic Culture: 90.1% (95% CI: 83.8-94.1%) |
| Compared to Enriched Toxigenic Culture: 79.6% (95% CI: 73.1-84.8%) | ||
| Clinical Specificity | Not explicitly stated as "acceptance criteria" but compared to predicate devices | Compared to Direct Toxigenic Culture: 93.0% (95% CI: 91.0-94.5%) |
| Compared to Enriched Toxigenic Culture: 95.8% (95% CI: 94.2-97.0%) |
Note: For clinical performance, the acceptance criteria are not explicitly stated as numerical targets within the document provided. Instead, the performance is reported and implicitly compared to predicate devices or considered acceptable for the intended use. The reproducibility acceptance criteria are inferred from the 100% or >90% agreement shown in the predicate device data section of the comparison table.
2. Sample Size Used for the Test Set and Data Provenance
- Reproducibility: A "panel" of contrived samples (high negative, medium positive) spiked with C. difficile bacterial stock was used. For each of the three sites, the Low Positive, Positive Control, High Negative, and No Template Control samples were tested in 30 replicates each (with 29 replicates for one medium positive sample at one site).
- Limit of Detection (LoD): The LoD was determined using three replicates in an initial screening phase, followed by confirmation using twenty replicates for two C. difficile bacterial strains.
- Analytical Reactivity: 20 different C. difficile strains were tested, each in triplicate.
- Cross-Reactivity: A total of 119 potential cross-reactants were tested. Each cross-reactant and baseline sample was tested in multiple replicates (implied at least 3, as mentioned in the interference section that "One replicate reported as "Invalid"... in initial run of three replicates").
- Interference: 21 potentially interfering substances were spiked into low positive C. difficile samples and tested. The results typically show 3/3 replicates detected for each substance and strain, with some exceptions tested in 5/5 or with repeat runs for invalid/not detected results.
- Clinical Studies: A total of 970 prospectively collected stool specimens were obtained.
- Data Provenance:
- Site 1: Prospectively collected fresh specimens from the East Coast of the US.
- Site 2: Prospectively collected fresh specimens (and performed toxigenic culture for all specimens, including those from other sites) from the East Coast of the US.
- Site 3: Prospectively collected clinical specimens from the West Coast of the US and Upper Mid-West of the US.
- Data Provenance:
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Reproducibility, LoD, Analytical Reactivity, Cross-Reactivity, Interference: Ground truth for these analytical studies was established by preparing bacterial stocks and contrived samples with known concentrations and identities. This does not typically involve human experts in the same way clinical ground truth does. The experiments were likely designed and performed by trained laboratory personnel. The document does not specify the number or qualifications of these individuals.
- Clinical Studies:
- Ground Truth Method: "Toxigenic Culture" (Direct Culture + Toxin Assay and Enriched Culture + Toxin Assay) was used as the reference method. This is a laboratory-based method.
- Experts: The document does not specify the number of experts or their qualifications for establishing the toxigenic culture results. It states that "Site 2 conducted all direct and enriched toxigenic culture testing for all specimens," implying trained laboratory personnel rather than a panel of clinical experts for interpretation.
4. Adjudication Method for the Test Set
- Analytical Studies (Reproducibility, LoD, Analytical Reactivity, Cross-Reactivity, Interference): Adjudication methods are not explicitly described for these laboratory experiments. The results are typically quantitative or categorical (detected/not detected) based on the assay's output. Any "invalid" results (e.g., in reproducibility and interference sections) led to retesting or were noted.
- Clinical Studies: The reference method for clinical studies was "Toxigenic Culture." The document does not describe any specific adjudication process involving multiple experts for the toxigenic culture results. "Site 2 conducted all direct and enriched toxigenic culture testing."
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed. This study focuses on an in vitro diagnostic (IVD) assay (PCR) for detecting a pathogen, not on human readers interpreting images or data with or without AI assistance. Therefore, there is no effect size of human readers improving with AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Yes, this study primarily assesses the standalone performance of the Simplexa™ C. difficile Universal Direct assay (an algorithm-based PCR method) without human interpretation as part of the primary diagnostic output. The device itself is an automated real-time PCR system. While human operators are involved in sample preparation and running the instrument, the result (detected/not detected) is generated automatically by the "detection techniques" of "Real time PCR with bi-functional fluorescent probe-primers using the 3M Integrated Cycler."
7. The Type of Ground Truth Used
- Analytical Studies: Ground truth was established through known concentrations of bacterial strains and contrived samples for LoD, analytical reactivity, cross-reactivity, and interference studies.
- Clinical Studies: Ground truth for the clinical agreement study was established using Toxigenic Culture (Direct Culture + Toxin Assay and Enriched Culture + Toxin Assay). This is a laboratory-based gold standard for detecting toxigenic C. difficile.
8. The Sample Size for the Training Set
- The document describes premarket notification (510(k)) studies for a diagnostic device. It does not mention a "training set" in the context of machine learning. The studies described are validation studies (analytical and clinical) performed on the final device. Therefore, a specific sample size for a training set is not applicable in this context.
9. How the Ground Truth for the Training Set Was Established
- As a "training set" for machine learning is not applicable in this context, the method for establishing its ground truth is also not applicable.
{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
| Applicant | Focus Diagnostics, Inc.11331 Valley View StreetCypress, California 90630USA |
|---|---|
| Establishment Registration No. | 2023365 |
| Contact Person | Sharon YoungTel 562.240.6680Fax 562.240.6529 |
| 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. difficileUniversal Direct | illumigene™ C. difficile | BD GeneOhm™ Cdiff |
| Intended Use | The Focus DiagnosticsSimplexa™ C. difficileUniversal Direct is a real-time polymerase chainreaction (PCR) assay and isintended for use on the 3MIntegrated Cycler instrumentfor the detection of toxigenicClostridium difficile toxin Bgene (tcdB) in liquid orunformed stool samplesfrom individuals suspectedof C. difficile infection. Thistest aids in the diagnosis ofClostridium difficileassociated disease (CDAD). | The Illumigene™ C. difficileDNA amplification assay,performed on the illumipro-10, is a qualitative in vitrodiagnostic test for the directdetection of toxigenic C.difficile in human stoolspecimens from pediatricand adult patients suspectedof having Clostridiumdifficile-associated disease(CDAD).The Illumigene™ C. difficileassay utilizes loop-mediatedisothermal DNAamplification (LAMP)technology to detect thepathogenicity locus (PaLoc)of toxigenic Clostridiumdifficile. The Clostridiumdifficile PaLoc is a genesegment present in allknown toxigenic C. difficilestrains. The C. difficilePaLoc codes for both theToxin A gene (tcdA) and theToxin B gene (tcdB), hasconserved border regions,and is found at the same siteon the C. difficile genome forall toxigenic strains. TheIllumigene™ C. difficileassay detects the PaLoc bytargeting a partial DNAfragment on the Toxin Agene. The tcdA target regionwas selected as an intactregion remaining in allknown A+B+ and A-B+toxinotypes.Illumigene™ C. difficile isintended for use in hospital,reference or state laboratorysettings. The device is notintended for point-of-careuse. | The BD GeneOhm™ C diffAssay is a rapid in vitrodiagnostic test for the direct,qualitative detection of C.difficile toxin B gene (tcdB)in human liquid or soft stoolspecimens from patientssuspected of havingClostridium difficile-associated disease (CDAD).The test, based on real-timePCR, is intended for use asan aid in diagnosis of CDAD.The test is performeddirectly on the specimen,utilizing polymerase chainreaction (PCR) for theamplification of specifictargets and fluorogenictarget-specific hybridizationprobes for the detection ofthe amplified DNA. |
| Assay Targets | C. difficile toxin B gene(tcdB) | PaLoc region (encodingtcdA and tcdB) | C. difficile toxin B gene(tcdB) |
| Item | Device | Predicate 1 | Predicate 2 |
| Name | Simplexa™ C. difficileUniversal 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 minutepreheating step. | Off-board 10 minutepreheating step, followed byvortexing. | 5 minutes of vortexing,sample centrifugation,followed by a 5 minuteheating 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 BacterialCulture | Cytotoxicity Assay |
| Limit of Detection | ATCC 43255560.7 CFU/mL or 1.12CFU/PCRNAP 1A 76.3 CFU/mL or0.15 CFU/PCR | VPI 10463, 4CFU/test2007431, 32 CFU/testCFI, 64 CFU/test2006240, 32 CFU/testB18, 64 CFU/test2007858, 32 CFU/test8864, 64 CFU/test | ATCC 4325510 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 reproducibilityusing dilutions of highnegative at 1:100 dilution80% (72/90) and 1:10dilution 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 ATCC43593 | 1.00 x 106 cfu/mL | No Cross Reactivity Observed |
| 30 | Clostridium difficile non-toxigenicATCC43601 | 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. Entericaserovar 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 | InterferentConcentration | Detected/Total | |
|---|---|---|---|---|
| C. difficile Strain -ATCC43255 | C. difficile Strain - NAP1A | |||
| 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 | AluminumHydroxide,MagnesiumHydroxide | 0.1 mg/ml | 3/3 | 3/3 |
| Antacid Generic | CalciumCarbonate | 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 | MagnesiumHydroxide | 0.2 mg/ml | 3/3 | 3/3 |
| Moist towelettes generic | BenzalkoniumChloride | 10%(v/v) | 3/3 | 3/3 |
| Mucin | Mucin | 3 mg/ml | 3/3 | 3/3 |
| Nystatin | Nystatin | 10000 USPunits/ml | 3/3 | 3/3 |
| Palmitic acid | Palmitic acid | 2 mg/ml | 3/3 | 3/3 |
| Pepto-Bismol | BismuthSubsalicylate | 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
| ్లోInterferents12 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 | InterferentConcentration: > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > | Detected/Total | |
|---|---|---|---|---|
| C. difficile Strain -ATCC43255 | "C. difficile Strain - NAP14 | |||
| 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 (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7.100 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
§ 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.