(61 days)
Premier C. difficile GDH is a qualitative enzyme immunoassay screening test to detect Clostridium difficile antigen, glutamate dehydrogenase, in fecal specimens from symptomatic persons suspected of having C. difficile infection (CDI). This test does not distinguish between toxigenic strains of C. difficile. Samples from symptomatic patients that produce positive results with this test must be further tested with an assay designed to detect toxigenic C. difficile strains and assist with the diagnosis of CDI.
Premier C. difficile GDH is a qualitative enzyme immunoassay screening test to detect Clostridium difficile antigen, glutamate dehydrogenase, in fecal specimens from symptomatic persons suspected of having C. difficile infection (CDI). The assay consists of Premier C. difficile GDH Microwells coated with polyclonal antibodies specific to C. difficile GDH, Premier C. difficile GDH Enzyme Conjugate, Premier 20X Wash Buffer II, Premier Substrate I, Premier Stop Solution I, Premier C. difficile GDH Sample Diluent/Negative Control, and Premier C. difficile GDH Positive Control.
Here's a summary of the acceptance criteria and study findings for the Premier C. difficile GDH assay, based on the provided text:
Acceptance Criteria and Device Performance
The document implicitly defines acceptance criteria through the reported performance characteristics. The primary measure of clinical performance is the comparison to bacterial C. difficile culture.
Table 1: Acceptance Criteria and Reported Device Performance (Clinical Study)
| Performance Metric | Acceptance Criteria (Implicit) | Reported Device Performance | Comments |
|---|---|---|---|
| Clinical Sensitivity | High % (e.g., above 85-90%) | 92.3% (95% Cl: 86.0 - 95.9%) | Met the expectation for a high sensitivity screening test. |
| Clinical Specificity | High % (e.g., above 90-95%) | 95.8% (95% Cl: 93.9 – 97.1%) | Met the expectation for a high specificity screening test. |
| Overall Correlation | High % (e.g., above 90%) | 95.2% (93.4 - 96.5%) | Good overall agreement with the reference method. |
| Analytical Sensitivity (LoD) | Defined as detectable at a specific concentration with 95% probability | 8 ng/mL (based on 45 replicates per measurand with 95% probability of positive response) | Clear analytical limit of detection established. |
| Interference Testing | No interference at specified concentrations of common substances | No interference observed for listed substances (e.g., Barium sulfate, Metronidazole, Vancomycin HCl) | Demonstrated robustness against common interfering substances. |
| Cross-Reactivity | No cross-reactivity with common microorganisms, or identified and noted | No cross-reactivity observed with a wide range of bacteria and viruses, except for Staphylococcus aureus (Cowan strain I) and Clostridium sporogenes. | Most common pathogens did not cross-react, but two specific Clostridium species and Staphylococcus aureus were noted as cross-reactive. |
| Strain Reactivity | Positive reactions with a representative panel of C. difficile strains | Positive reactions at 5.7 x 10^7 cells/mL with 30+ strains | Demonstrated ability to detect various C. difficile strains. |
| Reproducibility | 100% agreement for moderate positive, high negative, and negative samples | 100% agreement over 5 non-consecutive days, across 3 sites, 2 operators per site. | Excellent reproducibility across different sites and operators. |
Study Information
-
Sample sizes used for the test set and the data provenance:
- Test Set Sample Size: 733 qualified patient samples.
- Data Provenance: The data was collected prospectively (clinical trials conducted from November 2011) from independent clinical test sites located in the Midwestern and Southwestern regions of the United States. Gender and age ranges were reported (22 days to 99 years).
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document states that the performance characteristics were determined by comparison to bacterial C. difficile culture. It does not mention the use of human experts to establish ground truth for the clinical test set; rather, the gold standard for diagnosis was a laboratory method (bacterial culture).
-
Adjudication method for the test set:
- Since the ground truth was established by bacterial C. difficile culture, an expert adjudication method (like 2+1, 3+1) was not described or necessary. The comparison was directly against the culture results.
-
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No MRMC comparative effectiveness study was done. This device is an Enzyme Immunoassay (ELISA) kit, which is a laboratory test where results are read spectrophotometrically or visually from a microplate, not an imaging device requiring human interpretation of complex visual data. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable.
-
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Yes, the clinical performance described (sensitivity, specificity, correlation) represents the standalone performance of the Premier C. difficile GDH assay. It is an "algorithm only" in the sense that it is a biochemical assay designed to yield a direct result (positive/negative) based on antigen detection, without human interpretation influencing the diagnostic outcome beyond standard laboratory procedures (e.g., pipetting, reading the spectrophotometer).
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth used for the clinical performance evaluation was bacterial C. difficile culture.
-
The sample size for the training set:
- The document does not explicitly state a "training set" in the context of machine learning or AI models. For an ELISA kit, development typically involves analytical studies (sensitivity, specificity, interference, cross-reactivity, strain reactivity) and then clinical validation. The "analytical sensitivity" study used 45 replicates for each measurand. The "reproducibility" panels involved blind-coded samples tested multiple times. These studies contribute to the device's development and validation but are not a "training set" in the common AI sense.
-
How the ground truth for the training set was established:
- Again, the concept of a "training set" in the AI sense is not directly applicable. For the analytical studies, the "ground truth" (e.g., known concentration of C. difficile GDH antigen, presence/absence of interfering substances, known microorganisms) was established through controlled laboratory spiking and preparation of contrived samples. For the broader validation, bacterial C. difficile culture served as the reference standard.
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MAY - 3 2011
| 510(k) Application Premier C. difficile GDH |
|---|
| --------------------------------------------- |
| Description: | 510(k) Summary Premier C. difficile GDH |
|---|---|
| Identification: | Attachment 002 |
| Date: | March 01, 2011 |
| 510(k) number: | |
|---|---|
| Date of Preparation: | March 01, 2011 |
| Submitter: | Meridian Bioscience, Inc |
| Submitter's address: | 3471 River Hills Drive |
| Cincinnati, Ohio 45244 | |
| Contact: | Susan Bogar |
| Contact number: | (513) 271-3700 |
| Device name: | Premier C. difficile GDH |
| Common name: | Enzyme Immunoassay for C. difficile Common Antigen |
| Classification: | Antigen, C. difficile |
| MCB, CFR Section 866.2660 | |
| Predicate device: | K030992: TECHLAB C. DIFF CHEK™ - 60 ELISA |
| Reference comparator: | Bacterial culture |
Description of the device:
Premier C. difficile GDH is a qualitative enzyme immunoassay screening test to detect Clostridium difficile antigen, glutamate dehydrogenase, in fecal specimens from symptomatic persons suspected of having C. difficile infection (CDI). The assay consists of Premier C. difficile GDH Microwells coated with polyclonal antibodies specific to C. difficile GDH, Premier C. difficile GDH Enzyme Conjugate, Premier 20X Wash Buffer II, Premier Substrate I, Premier Stop Solution I, Premier C. difficile GDH Sample Diluent/Negative Control, and Premier C. difficile GDH Positive Control. ·
Intended Use:
Premier C. difficile GDH is a qualitative enzyme immunoassay screening test to detect Clostridium difficile antigen, glutamate dehydrogenase, in fecal specimens from symptomatic persons suspected of having C. difficile infection (CDI). This test does not distinguish between toxigenic strains of C. difficile. Samples from symptomatic patients that produce positive results with this test must be further tested with an assay designed to detect toxigenic C. difficile strains and assist with the diagnosis of CDI.
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Image /page/1/Picture/0 description: The image shows the logo for Meridian Bioscience, Inc. The logo consists of a globe graphic on the left, followed by the word "Meridian" in a bold, sans-serif font. Below "Meridian" is the text "Bioscience, Inc." in a smaller, also bolded, sans-serif font. A horizontal line separates the two lines of text.
510(k) Application Premier C. difficile GDH 510(k) Summary Premier C. difficile GDH Description: Identification: Attachment 002 Date: March 01, 2011
Table 1: Comparison to predicate device.
·
| Characteristic | Premier C. difficile GDH | TECHLAB C. DIFF CHEK-60 |
|---|---|---|
| Test Format | ELISA Microplate | ELISA Microplate |
| Intended Use | ||
| Qualitative/Quantitative | Qualitative | Qualitative |
| Target Antigen | Clostridium difficile glutamatedehydrogenase | Clostridium difficile glutamatedehydrogenase |
| Screening, Diagnostic, orIdentification Test | Screening | Screening |
| Specimen Types | ||
| Human Stool Unpreserved | Yes | Yes |
| Reagents/Components | Premier C. difficile GDH MicrowellsPremier C. difficile GDH EnzymeConjugatePremier 20X Wash Buffer IIPremier Substrate IPremier Stop Solution IPremier C. difficile GDH SampleDiluent/Negative ControlPremier C. difficile GDH Positive Control | Microassay plateEnzyme Conjugate20X Wash BufferSubstrateStop SolutionDiluentPositive Control |
| Diagnostic Marker | ||
| Antibody | Yes | Yes |
| Antibody Sources | ||
| Solid phase (microplate) | Rabbit polyclonal | Polyclonal |
| Enzyme Conjugate | Rabbit polyclonal | Mouse monoclonal |
| Sample Preparation | ||
| Unpreserved liquid/semi-solidstool | 50 µL of thoroughly mixed stool into200 µL Sample Diluent.Vortex for 15 seconds. | 50 µL specimen into 200 µL Diluent.Vortex for 10 seconds. |
| Testing Time | Approximately 60 minutes | Approximately 60 minutes |
| Equipment | ||
| General Laboratory Equipment | SpectrophotometerStatFax™- 2200 Incubator/Shaker(optional)Semiautomated Microplate Washer(optional) | Spectrophotometer |
| Reading Method | Spectrophotometric | VisualSpectrophotometric |
| Results Interpretation | ||
| Single Wavelength ( A450 nm) | Negative: < 0.200Positive: ≥ 0.200 | Negative : < 0.120Positive: ≥ 0.120 |
| Dual Wavelength | Negative: < 0.150Positive: ≥ 0.150A450/630 nm | Negative: < 0.080Positive: ≥ 0.080A450/620 nm |
| Visual Read | N/A | Positive: Any yellow colorNegative: Colorless |
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Image /page/2/Picture/0 description: The image shows the logo for Meridian Bioscience, Inc. The logo consists of a globe graphic on the left, followed by the word "Meridian" in a large, bold font. Below "Meridian" is the text "Bioscience, Inc." in a smaller, bold font. A horizontal line separates "Meridian" from "Bioscience, Inc."
510(k) Application Premier C. difficile GDH 510(k) Summary Premier C. difficile GDH Description: Identification: Attachment 002 Date: March 01, 2011
Performance Comparison, Non-clinical Tests
Analytical Sensitivity
Sensitivity studies were designed to determine within 95% confidence intervals the analytical limit of detection (LoD) of C. difficile GDH antigen diluted in a human stool matrix. The analytical sensitivity of this assay was based on 45 replicates for each measurand and with a stated probability (95%) of obtaining positive responses at the following levels of the measurand when spiked in stool: 8 ng/mL.
Interference Testing
Selected drugs and other non-microbial substances that might be present in stool samples from healthy persons or patients suspected of having C. difficile associated disease were added to three negative stool samples and three positive stool samples. The contrived positive specimens were prepared from a pool of donor stools that were confirmed as negative. The samples were inoculated with C. difficile strain 11186 at 8 ng/mL, the limit of detection for this assay. Potentially interfering substances were added at final concentrations of 5% V/V or greater. Dilution Controls for each sample were prepared by adding a phosphate-buffered saline solution in place of the potentially interfering substance. Each sample was tested in triplicate.
The following substances, at the specified saturated solvent/diluent concentrations, do not interfere with Premier C. difficile GDH test results in the final concentrations listed: Barium sulfate (5 mg/mL), Fecal fat (2.65 mg stearic acid and 1.3 mg palmitic acid/mL), Hemoglobin (3.2 mg/mL), Imodium AD (Loperamide HCl) (6.67 x 10ª mg/mL), Kaopectate® (Bismuth subsalicylate) (0.87 mg/ml), Metronidazole (12.5 mg/mL), Mucin (3.33 mg/mL), Mylanta® (Aluminum hydroxide w/ magnesium hydroxide) (4.2 mg/mL), Pepto-Bismoth subsalicylate) (0.87 mg/mL), Polyethylene glycol (79.05 mg/mL), Prilosec® (Omeprazol) (0.5 mg/mL), Simethicone (0.625 mg/mL), Tagamet® (Cimetidine) (0.5 mg/mL). Tums® (Calcium carbonate) (0.5 mg/mL), Vancomycin HCl (2.5 mg/mL), Whole blood (25%). White blood cells (5%).
Cross-reactivity Study
Potentially crossreactive microorganisms that might be present in stool samples from healthy persons or patients suspected of having C. difficile associated disease were added to a natural negative and contrived positive sample. The contrived positive specimens were prepared from a pool of donor stools that was confirmed negative. The contrived positive sample was prepared by spiking a confirmed negative sample with C. difficile strain 11186 at 8 ng/mL the limit of detection for this assay. Potentially cross-reactive microorganisms were added at final concentrations of 1.2 x 10 °CFU/mL (bacteria or fungi) or final concentrations greater than 1 x 10 °TC/Dg/mL (viruses). Dilution controls for each sample were prepared by adding a 0.85% saline solution in place of the potentially cross-reactive organisms.
The following microorganisms, at the indicated concentrations, do not interfere with Premier C. difficile GDH test results: Aeromonas hydrophila, Bacillus cereus, Bacillus subtilis, Bacteroides fragilis, Campylobacter coli, Campylobacter fetus, Campylobacter jejuni, Candido albicans, Citrobacter freundii, Clostridium butyricum, Clostridium bifermentans, Clostridium histolyticum novyi, Clostridium perfringens, Clostridium septicum, Clostridium sordellii, Clostridium tetani, Enterobacter cloocae, Enterobacter cloocae, Enterococus faecalis, Escherichia coli, Escherichia coli 0157:H7, Escherichia fergusonii, Helicobacter pylori, Klebsiella pneumoniae, Lactococus lactis, Listeria monocytogenes, Peptostreptococcus anaerobius, Plesiomonas shiqelloides, Porphyromonas asaccharolytica, Proteus vulgaris, Pseudomonas aeruginosa, Pseudomonas fluorescens, Salmonella Group B, Salmonella Group C, Salmonella Group E, Serratia liquifaciens, Serratia marcescens, Shigella boydii, Shigella sonnei, Staphylococcus aureus, Staphylococcus epidermidis,
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Image /page/3/Picture/0 description: The image shows the logo for Meridian Bioscience, Inc. The logo features a stylized globe on the left, followed by the word "Meridian" in a bold, italicized font. Below "Meridian" is the text "Bioscience, Inc." in a smaller, non-italicized font. A horizontal line separates "Meridian" from "Bioscience, Inc."
| 510(k) Application Premier C. difficile GDH | ||
|---|---|---|
| Description: | 510(k) Summary Premier C. difficile GDH | |
| Identification: | Attachment 002 | |
| Date: | March 01, 2011 |
Vibrio parahaemolyticus, Yersinio enterocolitica, Adenovirus Type 41, Coxsackievirus Strain B4, Echovirus Strain 11, Rotavirus Strain WA.
Stools spiked with Staphylococus aureus (Cowan strain I) and Clostridium sporogenes were found to be crossreactive with Premier C. difficile GDH.
Strain Reactivity
C. difficile stock cultures from different sources were tested and produced positive reactions at a concentration of 5.7 x 10 ' cells/mL with the Premier C. difficile GDH assay. Strains tested were as follows: 8864, 10463, 43598, 2004052, 2004111, 2004118, 2004205, 2004206, 2005070, 200525, 2006240, 2007431, 2007435, 2007858, 2008016, 2008029, 2008188, 2008341, 2008351, 2009018, 2009065, 2009099, 2009132, 2009277, 11186, B1, 818, B17, BK6, CF1, G1, J7, K12, Y1, 234, 586, 611, 620, 2C62, 2C165, C122, UNC 19904, X15076.
Performance Comparison, Clinical Tests
Clinical trials for the Premier C. difficile GDH assay were conducted from November 2011. Performance characteristics of the Premier C. difficile assay were determined by comparison to bacterial C. difficile culture. Independent clinical test sites located in the Midwestern and Southwestern regions of the United States evaluated a total of 733 qualified patient samples were collected from 337 (46.0%) males and 390 (53.2%) females. Gender was not defined for 6 (1%) patients. The age groups of patients range from 22 days to 99 years. No differences in test performance were observed based on patient age, gender, or geographic location. Overall sensitivity was determined to be 92.3% (95% Cl: 86.0 - 95.9%). Overall specificity was determined to be 95.8% (95% Cl: 93.9 – 97.1%). Subsequent tables show overall assay performance as well as performance by clinical site and patient age.
| Premier C. difficile GDH | |||
|---|---|---|---|
| Culture | Positive | Negative | Total |
| Positive | 108 | 9 | 117 |
| Negative | 26 | 590 | 616 |
| Total | 134 | 599 | 733 |
| 95% CI | |||
| Sensitivity | 108/117 | 92.3% | 86.0 - 95.9% |
| Specificity | 590/616 | 95.8% | 93.9 - 97.1% |
| Correlation | 698/733 | 95.2% | 93.4 - 96.5% |
| Table 2: Performance Characteristics for Premier C. difficile GDH |
|---|
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Image /page/4/Picture/0 description: The image shows the logo for Meridian Bioscience, Inc. The logo consists of a globe on the left, followed by the word "Meridian" in a bold, sans-serif font. Below "Meridian" is the text "Bioscience, Inc." in a smaller, sans-serif font. There is a line separating the two lines of text.
| 510(k) Application Premier C. difficile GDH | ||
|---|---|---|
| Description: | 510(k) Summary Premier C. difficile GDH | |
| Identification: | Attachment 002 | |
| Date: | March 01, 2011 |
Table 3: Performance characteristics by site.
| PremierC. difficileGDH | Positive Samples | Negative Samples | |||||
|---|---|---|---|---|---|---|---|
| Clinical Site | PremierGDH/Culture | Sensitivity % | 95% CI | PremierGDH/Culture | Specificity % | 95% CI | |
| Site 1 | 13/16 | 81.3% | 57.0 - 93.4% | 84/87 | 96.6% | 90.3 – 98.8% | |
| Site 2 | 28/30 | 93.3% | 78.7 - 98.2% | 132/140 | 94.3% | 89.1 - 97.1% | |
| Site 3 | 44/46 | 95.7% | 85.5 - 98.8% | 147/153 | 96.1% | 91.7 – 98.2% | |
| Site 4 | 15/15 | 100.0% | 79.6 - 100% | 169/175 | 96.6% | 92.7 - 98.4% | |
| Site 5 | 8/10 | 80.0% | 49.0 - 94.3% | 58/61 | 95.1% | 86.5 - 98.3% |
Table 4: Performance Data (patients less than 2 years of age)
| Culture | Premier C. difficile GDH | ||
|---|---|---|---|
| Positive | Negative | Total | |
| Positive | 21 | 2 | 23 |
| Negative | 3 | 54 | 57 |
| Total | 24 | 56 | 80 |
| 95% CI | |||
| Sensitivity | 21/23 | 91.3% | 73.2-97.6% |
| Specificity | 54/57 | 94.7% | 85.6-98.2% |
| Correlation | 75/80 | 93.8% | 86.2-97.3% |
Table 5: Performance Data (patients 2 years of age and greater)
| Premier C. difficile GDH | |||
|---|---|---|---|
| Culture | Positive | Negative | Total |
| Positive | 87 | 7 | 94 |
| Negative | 23 | 536 | 559 |
| Total | 110 | 543 | 653 |
| 95% CI | |||
| Sensitivity | 87/94 | 92.6% | 85.4 - 96.3% |
| Specificity | 536/559 | 95.9% | 93.9 - 97.2% |
| Correlation | 623/653 | 95.4% | 93.5 - 96.8% |
·
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Image /page/5/Picture/0 description: The image shows the logo for Meridian Bioscience, Inc. The logo features a globe graphic on the left, followed by the word "Meridian" in a bold, italicized font. Below "Meridian" is the text "Bioscience, Inc." in a smaller, also bold and italicized font. A horizontal line separates the two lines of text.
| 510(k) Application Premier C. difficile GDH | |
|---|---|
| Description: | 510(k) Summary Premier C. difficile GDH |
| Identification: | Attachment 002 |
| Date: | March 01, 2011 |
Table 6: Overall results by patient age.
| PremierC. difficileGDH | Positive Samples | Negative Samples | ||||
|---|---|---|---|---|---|---|
| Patient Age | PremierGDH/Culture | Sensitivity % | 95% CI | PremierGDH/Culture | Specificity % | 95% CI |
| <2 years | 21/23 | 91.3% | 73.2 - 97.6% | 54/57 | 94.7% | 85.6 - 98.2% |
| ≥2 years to 12years | 27/28 | 96.4% | 82.3 - 99.4% | 118/122 | 96.7% | 91.9 - 98.7% |
| >12 years to 21years | 10/13 | 76.9% | 49.7 - 91.8% | 72/75 | 96.0% | 88.9 - 98.6% |
| >21 years | 50/53 | 94.3% | 84.6 - 98.1% | 345/361 | 95.6% | 92.9 - 97.3% |
| Not Defined | 0/0 | N/A | N/A | 1/1 | 100.0% | 20.7 - 100.0% |
Reproducibility
Reproducibility panels were performed by three clinical laboratories using blind coded panels. Samples were randomly sorted within each panel to mask identities. Each panel consisted of 3 contrived moderately positive specimens, 3 contrived low positive samples, 3 contrived high- negative specimens, and 1 natural negative specimen. Panels were tested at three independent laboratories by two operators at each laboratory, twice each day over 5 non-consecutive days. The expected results were obtained with all samples by all technologists at all test sites at each time interval. Reproducibility of the assay is 100% for moderate positive, high negative, and negative samples.
As seen in the following tables, the expected results were obtained 100% of the time.
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| 510(k) A | |
|---|---|
| Description | |
| Identification | |
| Date: |
pplication Premier C. difficile GDH 510(k) Summary Premier C. difficile GDH ion: Attachment 002 ation: March 01, 2011
Table 7: Intra and inter assay variability data for all sites (single wavelength).
| PanelMembers | SampleN | GrandMean AL | Between-Day | Between-Run | Between-Site | Total | Result | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| SD | %CV | SD | %CV | SD | %CV | SD | %CV | ||||
| PC | 30 | 1.944 | 0.087 | 4.5% | 0.124 | 6.4% | 0.207 | 10.6% | 0.279 | 14.3% | Positive |
| NC | 30 | 0.053 | 0.006 | 10.6% | 0.010 | 19.6% | 0.011 | 21.1% | 0.020 | 36.6% | Negative |
| MP 1 | 30 | 1.957 | 0.201 | 10.3% | 0.256 | 13.1% | 0.193 | 9.9% | 0.359 | 18.3% | Positive |
| MP 2 | 30 | 1.936 | 0.200 | 10.3% | 0.282 | 14.9% | 0.285 | 14.7% | 0.398 | 20.6% | Positive |
| MP 3 | 30 | 1.758 | 0.100 | 5.7% | 0.205 | 11.7% | 0.505 | 28.7% | 0.522 | 29.7% | Positive |
| LP 1 | 30 | 0.705 | 0.066 | 9.4% | 0.096 | 13.6% | 0.092 | 13.1% | 0.153 | 21.7% | Positive |
| LP 2 | 30 | 0.670 | 0.066 | 9.9% | 0.090 | 13.4% | 0.150 | 22.4% | 0.184 | 27.4% | Positive |
| LP 3 | 30 | 0.694 | 0.055 | 8.0% | 0.095 | 13.7% | 0.120 | 17.3% | 0.189 | 27.2% | Positive |
| HN 1 | 30 | 0.057 | 0.006 | 10.7% | 0.008 | 14.2% | 0.016 | 27.7% | 0.017 | 29.7% | Negative |
| HN 2 | 30 | 0.058 | 0.008 | 13.8% | 0.011 | 18.5% | 0.016 | 27.1% | 0.017 | 29.5% | Negative |
| HN 3 | 30 | 0.059 | 0.008 | 13.1% | 0.012 | 20.3% | 0.015 | 24.6% | 0.024 | 39.8% | Negative |
| WN 1 | 30 | 0.050 | 0.002 | 3.0% | 0.002 | 4.4% | 0.014 | 28.4% | 0.013 | 25.4% | Negative |
Legend: PC=Positive control, NC=Negative control, MP=Moderate positive, HN=High negative, WN=Weak negative
Interpretation of Results at OD450:
Positive Control: ≥ 0.600 Negative Control: < 0.150 Positive: ≥ 0.200 Negative: <0.200
Table 8: Intra and inter assay variability data (single wavelength) - Site 1: CCHMC Lot 2 611096.004.
| Panel | Sample N | GrandMean AL | Between-Day | Between-Tech | Total | Result | |||
|---|---|---|---|---|---|---|---|---|---|
| Members | SD | %CV | SD | %CV | SD | %CV | |||
| PC | 10 | 1.845 | 0.120 | 6.5% | 0.109 | 5.9% | 0.168 | 9.1% | Positive |
| NC | 10 | 0.064 | 0.007 | 11.5% | 0.005 | 8.3% | 0.009 | 13.8% | Negative |
| MP 1 | 10 | 1.871 | 0.279 | 14.9% | 0.052 | 2.8% | 0.305 | 16.3% | Positive |
| MP 2 | 10 | 1.947 | 0.174 | 8.9% | 0.217 | 11.2% | 0.284 | 14.6% | Positive |
| MP 3 | 10 | 1.896 | 0.109 | 5.7% | 0.237 | 12.5% | 0.290 | 15.3% | Positive |
| LP 1 | 10 | 0.673 | 0.060 | 8.9% | 0.126 | 18.7% | 0.133 | 19.8% | Positive |
| LP 2 | 10 | 0.576 | 0.040 | 7.0% | 0.051 | 8.9% | 0.108 | 18.8% | Positive |
| LP 3 | 10 | 0.649 | 0.170 | 26.2% | 0.048 | 7.4% | 0.176 | 27.1% | Positive |
| HN 1 | 10 | 0.074 | 0.004 | 5.3% | 0.008 | 10.7% | 0.010 | 13.0% | Negative |
| HN 2 | 10 | 0.074 | 0.007 | 9.9% | 0.011 | 14.3% | 0.012 | 16.2% | Negative |
| HN 3 | 10 | 0.075 | 0.021 | 27.5% | 0.018 | 24.5% | 0.030 | 40.4% | Negative |
| WN 1 | 10 | 0.066 | 0.006 | 9.3% | 0.001 | 2.1% | 0.007 | 10.6% | Negative |
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Image /page/7/Picture/0 description: The image shows the logo for Meridian Bioscience, Inc. The logo features a globe graphic on the left, followed by the word "Meridian" in a bold, sans-serif font. Below "Meridian" is the text "Bioscience, Inc." in a smaller, also bolded, sans-serif font. A horizontal line separates "Meridian" from "Bioscience, Inc."
| 510(k) Application Premier C. difficile GDH | |
|---|---|
| Description: | 510(k) Summary Premier C. difficile GDH |
| Identification: | Attachment 002 |
| Date: | March 01, 2011 |
Table 9: Intra and inter assay variability data (single wavelength) - Site 2: SHH Lot 1 611096.003.
| Panel | Sample N | GrandMean AL | Between-Day | Between-Tech | Total | Result | |||
|---|---|---|---|---|---|---|---|---|---|
| Members | SD | %CV | SD | %CV | SD | %CV | |||
| PC | 10 | 1.805 | 0.144 | 8.0% | 0.053 | 3.0% | 0.167 | 9.3% | Positive |
| NC | 10 | 0.054 | 0.018 | 34.3% | 0.022 | 41.0% | 0.029 | 54.5% | Negative |
| MP 1 | 10 | 1.821 | 0.262 | 14.4% | 0.187 | 10.2% | 0.344 | 18.9% | Positive |
| MP 2 | 10 | 1.646 | 0.325 | 19.7% | 0.002 | 0.1% | 0.376 | 22.8% | Positive |
| MP 3 | 10 | 1.198 | 0.156 | 13.0% | 0.045 | 3.8% | 0.260 | 21.7% | Positive |
| LP 1 | 10 | 0.633 | 0.107 | 16.9% | 0.054 | 8.5% | 0.127 | 20.0% | Positive |
| LP 2 | 10 | 0.592 | 0.131 | 22.1% | 0.006 | 1.0% | 0.139 | 23.5% | Positive |
| LP 3 | 10 | 0.603 | 0.133 | 22.1% | 0.052 | 8.6% | 0.134 | 22.2% | Positive |
| HN 1 | 10 | 0.043 | 0.009 | 20.2% | 0.005 | 10.4% | 0.013 | 30.1% | Negative |
| HN 2 | 10 | 0.043 | 0.006 | -13.7% | 0.006 | 13.5% | 0.009 | 21.4% | Negative |
| HN 3 | 10 | 0.045 | 0.013 | 28.7% | 0.010 | 22.4% | 0.019 | 42.0% | Negative |
| WN 1 | 10 | 0.039 | 0.001 | 1.7% | 0.001 | 2.5% | 0.002 | 6.1% | Negative |
Legend: PC=Positive control, NC=Negative control, MP=Moderate positive, HN=High negative, WN=Weak negative
Interpretation of Results at OD450: Positive Control: ≥ 0.600
Negative Control: < 0.150 Positive: ≥ 0.200 Negative: <0.200
Table 10: Intra and inter assay variability data (single wavelength) - Site 3: NCH Lot 3 611096.005.
| Panel | Grand | Between-Day | Between-Tech | Total | Result | ||||
|---|---|---|---|---|---|---|---|---|---|
| Members | Sample N | Mean AL | SD | %CV | SD | %CV | SD | %CV | |
| PC | 10 | 2.181 | 0.222 | 10.2% | 0.127 | 5.8% | 0.315 | 14.4% | Positive |
| NC | 10 | 0.042 | 0.002 | 4.7% | 0.002 | 4.4% | 0.003 | 7.2% | Negative |
| MP 1 | 10 | 2.178 | 0.220 | 10.1% | 0.278 | 12.8% | 0.346 | 15.9% | Positive |
| MP 2 | 10 | 2.215 | 0.233 | 10.5% | 0.226 | 10.2% | 0.330 | 14.9% | Positive |
| MP 3 | 10 | 2.179 | 0.212 | 9.7% | 0.224 | 10.3% | 0.401 | 18.4% | Positive |
| LP 1 | 10 | 0.809 | 0.109 | 13.5% | 0.107 | 13.3% | 0.151 | 18.7% | Positive |
| LP 2 | 10 | 0.844 | 0.096 | 11.4% | 0.143 | 16.9% | 0.166 | 19.7% | Positive |
| LP 3 | 10 | 0.830 | 0.083 | 10.1% | 0.139 | 16.8% | 0.185 | 22.2% | Positive |
| HN 1 | 10 | 0.053 | 0.006 | 12.0% | 0.007 | 14.1% | 0.010 | 19.4% | Negative |
| HN 2 | 10 | 0.056 | 0.012 | 21.1% | 0.005 | 8.5% | 0.013 | 22.9% | Negative |
| HN 3 | 10 | 0.058 | 0.006 | 9.9% | 0.002 | 3.9% | 0.007 | 12.4% | Negative |
| WN 1 | 10 | 0.045 | 0.002 | 4.1% | 0.001 | 3.2% | 0.004 | 9.0% | Negative |
{8}------------------------------------------------
Meridian
Sioscience, Inc.
| Application Premier C. difficile GDI1 40 1 . 0 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 | |
|---|---|
| escription: | C. difficile510(k) Summary Premie |
| identification · | AnaAttachment |
| Jate: | COMAا الام ڪال اFebruary |
Table 11: Reproducibility data (single wavelength) - Site 1: CCHMC, Lot 611096.00
| Day 1 | Day 1 | Day 2 | Day 2 | Day 3 | Day 3 | Day 4 | Day 4 | Day 5 | Day 5 | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Sample ID | Sample Qual.Result | Run 1(DH)* | Run 2(MJG)* | Run 1(DH)* | Run 2(MJG)* | Run 1(DH)* | Run 2(MJG)* | Run 1(DH)* | Run 2(MJG)* | Run 1(DH)* | Run 2(MJG)* | Result |
| PC | N/A | 1.756 | 2.038 | 1.868 | 1.725 | 1.495 | 1.820 | 1.820 | 2.081 | 1.898 | 1.946 | Positive |
| NC | 0.069 | 0.083 | 0.059 | 0.053 | 0.060 | 0.072 | 0.059 | 0.067 | 0.056 | 0.066 | Negative | |
| MP 1 | 1.694 | 1.549 | 2.099 | 2.072 | 1.307 | 1.728 | 2.241 | 1.967 | 1.829 | 2.223 | Positive | |
| MP 2 | 1.930 | 1.491 | 1.943 | 2.147 | 2.203 | 1.731 | 2.326 | 2.052 | 1.869 | 1.545 | 2.161 | Positive |
| MP 3 | 1.598 | 2.111 | 2.092 | 1.698 | 1.482 | 2.093 | 1.944 | 2.209 | 1.524 | 2.204 | Positive | |
| LP 1 | 0.484 | 0.568 | 0.887 | 0.781 | 0.684 | 0.459 | 0.731 | 0.542 | 0.723 | 0.572 | 0.785 | Positive |
| LP 2 | 0.452 | 0.669 | 0.726 | 0.500 | 0.484 | 0.548 | 0.601 | 0.623 | 0.434 | 0.719 | Positive | |
| LP 3 | 0.477 | 0.749 | 0.578 | 0.500 | 0.511 | 0.606 | 0.556 | 0.618 | 0.956 | 0.943 | Positive | |
| HN 1 | 0.063 | 0.085 | 0.070 | 0.089 | 0.066 | 0.086 | 0.075 | 0.063 | 0.069 | 0.076 | Negative | |
| HN 2 | 0.003 | 0.074 | 0.083 | 0.065 | 0.100 | 0.061 | 0.065 | 0.069 | 0.078 | 0.064 | 0.082 | Negative |
| HN 3 | 0.059 | 0.061 | 0.057 | 0.069 | 0.067 | 0.064 | 0.062 | 0.086 | 0.063 | 0.157 | Negative | |
| WN 1 | 0.002 | 0.078 | 0.075 | 0.059 | 0.066 | 0.060 | 0.064 | 0.071 | 0.062 | 0.057 | 0.068 | Negative |
| Average high negative value | 0.065 | 0.076 | 0.064 | 0.086 | 0.065 | 0.072 | 0.069 | 0.076 | 0.065 | 0.105 | ||
| Average low positive value | 0.499 | 0.768 | 0.695 | 0.561 | 0.485 | 0.628 | 0.566 | 0.655 | 0.654 | 0.816 | ||
| Percent Correlation | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% | ||
| Correlation of cut off Specimens | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% |
egend: PC=Positive control, NC=Negative control, MP=Moderate
Initials of person performing testing.
- Materials or person performing testing.
- Subject is resting.
interpretation of Results at ODaso:
Positive Control: 2 0.600
Negative Control: < 0.600
Positive Control: < 0.150
Negative: ≥ 0.200
Negative: <0.200
{9}------------------------------------------------
Image /page/9/Picture/9 description: The image shows the logo for Meridian Bioscience, Inc. The logo is vertically oriented, with the word "Meridian" stacked on top of "Bioscience, Inc." There is a graphic of a globe to the left of the text. The text is in a bold, sans-serif font.
| 510(k) Application Premier C. difficile GDH | ||
|---|---|---|
| Description: | 510(k) Summary Premier C. difficile GDH | |
| Identification: | Attachment 002 | |
| Date: | February 08, 2011 |
Table 12: Reproducibility data (single wavelength) - Site 2: SHH, Lot 611096.00
| Sample ID | Sample Qual.Result | Day 1Run 1(DM)* | Day 1Run 2(JM)* | Day 2Run 1(DM)* | Day 2Run 2(JM)* | Day 3Run 1(DM)* | Day 3Run 2(JM)* | Day 4Run 1(DM)* | Day 4Run 2(JM)* | Day 5Run 1(DM)* | Day 5Run 2(JM)* | Result |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| PC | N/A | 1.883 | 2.057 | 2.023 | 1.795 | 1.500 | 1.736 | 1.724 | 1.915 | 1.706 | 1.710 | Positive |
| NC | 0.037 | 0.038 | 0.038 | 0.039 | 0.037 | 0.077 | 0.040 | 0.066 | 0.039 | 0.127 | Negative | |
| MP 1 | 1.925 | 1.535 | 2.008 | 2.106 | 1.457 | 1.986 | 1.852 | 2.379 | 1.205 | 1.761 | Positive | |
| MP 2 | 1.930 | 1.679 | 1.466 | 2.400 | 1.741 | 1.015 | 1.506 | 1.856 | 1.889 | 1.275 | 1.636 | Positive |
| MP 3 | 1.101 | 1.363 | 1.812 | 1.104 | 1.078 | 1.097 | 0.909 | 1.316 | 1.251 | 0.953 | Positive | |
| LP 1 | 0.724 | 0.578 | 0.657 | 0.894 | 0.432 | 0.534 | 0.621 | 0.710 | 0.543 | 0.640 | Positive | |
| LP 2 | 0.484 | 0.571 | 0.360 | 0.819 | 0.778 | 0.465 | 0.578 | 0.581 | 0.689 | 0.503 | 0.576 | Positive |
| LP 3 | 0.461 | 0.512 | 0.795 | 0.864 | 0.530 | 0.553 | 0.519 | 0.685 | 0.526 | 0.585 | Positive | |
| HN 1 | 0.043 | 0.033 | 0.039 | 0.079 | 0.044 | 0.036 | 0.039 | 0.040 | 0.036 | 0.045 | Negative | |
| HN 2 | 0.003 | 0.043 | 0.040 | 0.038 | 0.067 | 0.037 | 0.037 | 0.039 | 0.048 | 0.037 | 0.043 | Negative |
| HN 3 | 0.043 | 0.039 | 0.038 | 0.099 | 0.037 | 0.039 | 0.038 | 0.045 | 0.035 | 0.041 | Negative | |
| WN 1 | 0.002 | 0.037 | 0.042 | 0.043 | 0.037 | 0.036 | 0.041 | 0.037 | 0.040 | 0.039 | 0.039 | Negative |
| Average high negative value | 0.043 | 0.037 | 0.038 | 0.082 | 0.039 | 0.037 | 0.039 | 0.044 | 0.036 | 0.043 | ||
| Average low positive value | 0.585 | 0.483 | 0.757 | 0.845 | 0.476 | 0.555 | 0.574 | 0.695 | 0.524 | 0.600 | ||
| Percent Correlation | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% | ||
| Correlation of cut off Specimens | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% | ||
| Legend: PC=Positive control NC=Negative control MP=Moderate positive LP=Low positive, HN=High negative, WN=Weak negative |
egend: PC=Positive control, NC=Negative control, MP=Moderate positive, LP=Low positive, HN=High negative, WN=Weak negative
gend: PC=Positive control, NC=Nep
lnterpretation of Results at ODaso:
Positive Control: ≥ 0.600
Negative Control: < 0.600
Positive Control: < 0.150
Negative: ≥ 0.200
Negative: <0.200
{10}------------------------------------------------
Meridian oscience, Inc
| 10(k) Application | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------And and the first of the first of the first of the first of the first andAPremier C. difficile GD |
|---|---|
| Description: | LE MINING AN A A510{k} Summary Premier C. difficile GDIAcres Active Active Act Act Act Act Act A |
| dentification: | 000Attachment |
| Date: | February 08, 2011 |
Table 13: Reproducibility data (single wavelength) - Site 3: NCH, Lot 611096.00
| Sample ID | Sample Qual.Result | Day 1Run 1(LS)* | Day 1Run 2(KE)* | Day 2Run 1(LS)* | Day 2Run 2(KE)* | Day 3Run 1(LS)* | Day 3Run 2(KE)* | Day 4Run 1(LS)* | Day 4Run 2(KE)* | Day 5Run 1(LS)* | Day 5Run 2(KE)* | Result |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| PC | N/A | 1.962 | 2.365 | 2.126 | 2.551 | 2.665 | 2.110 | 2.174 | 2.213 | 1.528 | 2.117 | Positive |
| NC | 0.040 | 0.042 | 0.048 | 0.040 | 0.047 | 0.041 | 0.040 | 0.040 | 0.041 | 0.040 | Negative | |
| MP 1 | 1.995 | 2.376 | 2.133 | 2.822 | 2.199 | 2.125 | 2.157 | 2.261 | 1.425 | 2.290 | Positive | |
| MP 2 | 1.930 | 1.755 | 2.568 | 2.269 | 2.592 | 2.466 | 2.260 | 2.202 | 2.36 | 1.585 | 2.094 | Positive |
| MP 3 | 1.667 | 2.845 | 1.892 | 2.372 | 2.589 | 2.038 | 2.373 | 2.347 | 1.582 | 2.083 | Positive | |
| LP 1 | 0.574 | 0.902 | 0.792 | 1.047 | 0.904 | 0.866 | 0.846 | 0.847 | 0.549 | 0.763 | Positive | |
| LP 2 | 0.484 | 0.587 | 1.037 | 0.741 | 0.976 | 0.976 | 0.909 | 0.849 | 0.969 | 0.560 | 0.832 | Positive |
| LP 3 | 0.547 | 0.995 | 0.806 | 1.008 | 1.038 | 0.774 | 0.738 | 0.960 | 0.531 | 0.907 | Positive | |
| HN 1 | 0.041 | 0.058 | 0.070 | 0.059 | 0.045 | 0.056 | 0.045 | 0.057 | 0.038 | 0.062 | Negative | |
| HN 2 | 0.003 | 0.066 | 0.061 | 0.059 | 0.084 | 0.044 | 0.046 | 0.056 | 0.060 | 0.040 | 0.048 | Negative |
| HN 3 | 0.056 | 0.061 | 0.074 | 0.056 | 0.051 | 0.047 | 0.061 | 0.057 | 0.056 | 0.061 | Negative | |
| WN 1 | 0.002 | 0.042 | 0.041 | 0.053 | 0.038 | 0.045 | 0.047 | 0.044 | 0.047 | 0.045 | 0.046 | Negative |
| Average high negative value | 0.054 | 0.060 | 0.068 | 0.066 | 0.047 | 0.050 | 0.054 | 0.058 | 0.045 | 0.057 | ||
| Average low positive value | 0.569 | 0.978 | 0.780 | 1.010 | 0.973 | 0.850 | 0.811 | 0.925 | 0.547 | 0.834 | ||
| Percent Correlation | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% | ||
| Correlation of cut off Specimens | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% |
egend: PC-Positive control, NC=Negative control, MP=Moderate positive, LN=High negative, WN=Weak negative
Initials of person performing testing.
- Number of persons performing testing at site:
lnterpretation of Results at ODaso:
Positive Control: ≥ 0.600
Negative Control: < 0.600
Positive Control: < 0.150
Negative: ≥ 0.200
Negative: <0.200
{11}------------------------------------------------
Image /page/11/Picture/0 description: The image shows the logo for Meridian Bioscience, Inc. The logo features a globe graphic on the left, followed by the word "Meridian" in a bold, italicized font. Below "Meridian" is the phrase "Bioscience, Inc." in a smaller, bold font. A horizontal line separates "Meridian" from "Bioscience, Inc."
| 510(k) Application Premier C. difficile GDH | |
|---|---|
| Description: | 510(k) Summary Premier C. difficile GDH |
| Identification: | Attachment 002 |
| Date: | February 08, 2011 |
Table 14: Intra and inter assay variability data for all sites (dual wavelength).
| Panel | Sample | Grand | Between-Day | Between-Run | Between-Site | Total | Result | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Members | N | Mean AL | SD | %CV | SD | %CV | SD | %CV | SD | %CV | |
| PC | 30 | 1.888 | 0.088 | 4.7% | 0.121 | 6.4% | 0.208 | 11.0% | 0.276 | 14.6% | Positive |
| NC | 30 | 0.012 | 0.007 | 55.3% | 0.010 | 86.7% | 0.008 | 64.0% | 0.017 | 147.6% | Negative |
| MP 1 | 30 | 1.899 | 0.200 | 10.5% | 0.253 | 13.3% | 0.196 | 10.3% | 0.356 | 18.7% | Positive |
| MP 2 | 30 | 1.881 | 0.197 | 10.5% | 0.279 | 15.2% | 0.281 | 14.9% | 0.393 | 20.9% | Positive |
| MP 3 | 30 | 1.666 | 0.179 | 10.7% | 0.239 | 14.3% | 0.451 | 27.1% | 0.540 | 32.4% | Positive |
| LP 1 | 30 | 0.659 | 0.066 | 10.1% | 0.097 | 14.8% | 0.093 | 14.2% | 0.155 | 23.6% | Positive |
| LP 2 | 30 | 0.626 | 0.066 | 10.5% | 0.090 | 14.4% | 0.150 | 23.9% | 0.183 | 29.3% | Positive |
| LP 3 | 30 | 0.647 | 0.053 | 8.2% | 0.092 | 14.3% | 0.116 | 17.9% | 0.186 | 28.8% | Positive |
| HN 1 | 30 | 0.013 | 0.005 | 35.9% | 0.005 | 38.3% | 0.006 | 48.2% | 0.011 | 81.7% | Negative |
| HN 2 | 30 | 0.016 | 0.008 | 54.0% | 0.011 | 69.8% | 0.009 | 56.4% | 0.014 | 87.3% | Negative |
| HN 3 | 30 | 0.019 | 0.009 | 48.2% | 0.013 | 69.9% | 0.012 | 62.8% | 0.025 | 131.6% | Negative |
| WN 1 | 30 | 0.008 | 0.001 | 9.8% | 0.002 | 21.0% | 0.006 | 81.2% | 0.006 | 76.3% | Negative |
Table 15: Intra and inter assay variability data (dual wavelength) - Site 1: CCHMC Lot 2 611096.004.
| PanelMembers | Sample N | GrandMean AL | Between-DaySD | Between-Day%CV | Between-TechSD | Between-Tech%CV | TotalSD | Total%CV | Result |
|---|---|---|---|---|---|---|---|---|---|
| PC | 10 | 1.780 | 0.116 | 6.5% | 0.094 | 5.3% | 0.163 | 9.1% | Positive |
| NC | 10 | 0.013 | 0.003 | 19.5% | 0.001 | 6.3% | 0.003 | 20.9% | Negative |
| MP 1 | 10 | 1.801 | 0.273 | 15.1% | 0.029 | 1.6% | 0.294 | 16.3% | Positive |
| MP 2 | 10 | 1.885 | 0.172 | 9.1% | 0.202 | 10.7% | 0.278 | 14.7% | Positive |
| MP 3 | 10 | 1.841 | 0.108 | 5.9% | 0.240 | 13.0% | 0.298 | 16.2% | Positive |
| LP 1 | 10 | 0.619 | 0.056 | 9.1% | 0.125 | 20.2% | 0.132 | 21.3% | Positive |
| LP 2 | 10 | 0.528 | 0.043 | 8.2% | 0.052 | 9.9% | 0.109 | 20.6% | Positive |
| LP 3 | 10 | 0.599 | 0.170 | 28.4% | 0.043 | 7.2% | 0.177 | 29.5% | Positive |
| HN 1 | 10 | 0.020 | 0.006 | 29.1% | 0.001 | 6.3% | 0.008 | 41.6% | Negative |
| HN 2 | 10 | 0.025 | 0.010 | 41.2% | 0.004 | 14.1% | 0.013 | 50.6% | Negative |
| HN 3 | 10 | 0.033 | 0.027 | 81.0% | 0.017 | 52.9% | 0.036 | 109.3% | Negative |
| WN 1 | 10 | 0.015 | 0.002 | 13.7% | 0.002 | 11.3% | 0.004 | 29.3% | Negative |
Legend: PC=Positive control, NC=Negative control, MP=Moderate positive, HN=High negative, WN=Weak negative
Interpretation of Results at OD 450/630:
Positive Control: ≥ 0.600 Negative Control: < 0.100 Positive: Negative: < 0.150
{12}------------------------------------------------
| Image: MeridianBioscience, Inc. | 510(k) Application Premier C. difficile GDH |
|---|---|
| Description: 510(k) Summary Premier C. difficile GDH | |
| Identification: Attachment 002 | |
| Date: February 08, 2011 |
Table 16: Intra and inter assay variability data (dual wavelength) - Site 2: SHH Lot 1 611096.003.
| Panel | Grand | Between-Day | Between-Tech | Total | Result | ||||
|---|---|---|---|---|---|---|---|---|---|
| Members | Sample N | Mean AL | SD | %CV | SD | %CV | SD | %CV | |
| PC | 10 | 1.757 | 0.141 | 8.0% | 0.059 | 3.3% | 0.165 | 9.4% | Positive |
| NC | 10 | 0.019 | 0.018 | 97.6% | 0.022 | 120.0% | 0.029 | 157.3% | Negative |
| MP 1 | 10 | 1.772 | 0.260 | 14.7% | 0.183 | 10.3% | 0.341 | 19.2% | Positive |
| MP 2 | 10 | 1.599 | 0.322 | 20.1% | 0.003 | 0.2% | 0.370 | 23.1% | Positive |
| MP 3 | 10 | 1.154 | 0.154 | 13.4% | 0.046 | 4.0% | 0.256 | 22.2% | Positive |
| LP 1 | 10 | 0.592 | 0.106 | 17.9% | 0.050 | 8.5% | 0.125 | 21.1% | Positive |
| LP 2 | 10 | 0.553 | 0.129 | 23.4% | 0.004 | 0.7% | 0.137 | 24.9% | Positive |
| LP 3 | 10 | 0.564 | 0.133 | 23.5% | 0.050 | 8.9% | 0.133 | 23.5% | Positive |
| HN 1 | 10 | 0.008 | 0.009 | 106.4% | 0.005 | 59.6% | 0.013 | 152.1% | Negative |
| HN 2 | 10 | 0.008 | 0.006 | 82.6% | 0.004 | 55.8% | 0.009 | 120.3% | Negative |
| HN 3 | 10 | 0.011 | 0.013 | 125.0% | 0.009 | 83.3% | 0.019 | 179.1% | Negative |
| WN 1 | 10 | 0.003 | 0.001 | 24.2% | 0.001 | 25.0% | 0.001 | 42.1% | Negative |
Table 17: Intra and inter assay variability data (dual wavelength) - Site 3: NCH Lot 3 611096.005.
| Panel | Grand | Between-Day | Between-Tech | Total | Result | ||||
|---|---|---|---|---|---|---|---|---|---|
| Members | Sample N | Mean AL | SD | %CV | SD | %CV | SD | %CV | |
| PC | 10 | 2.128 | 0.218 | 10.2% | 0.132 | 6.2% | 0.310 | 14.6% | Positive |
| NC | 10 | 0.004 | 0.001 | 22.8% | 0.000 | 7.9% | 0.001 | 26.8% | Negative |
| MP 1 | 10 | 2.126 | 0.219 | 10.3% | 0.277 | 13.0% | 0.345 | 16.2% | Positive |
| MP 2 | 10 | 2.160 | 0.231 | 10.7% | 0.227 | 10.5% | 0.327 | 15.2% | Positive |
| MP 3 | 10 | 2.003 | 0.475 | 23.7% | 0.049 | 2.4% | 0.578 | 28.9% | Positive |
| LP 1 | 10 | 0.766 | 0.119 | 15.5% | 0.119 | 15.5% | 0.159 | 20.8% | Positive |
| LP 2 | 10 | 0.798 | 0.094 | 11.7% | 0.147 | 18.4% | 0.166 | 20.8% | Positive |
| LP 3 | 10 | 0.779 | 0.095 | 12.1% | 0.133 | 17.1% | 0.182 | 23.4% | Positive |
| HN 1 | 10 | 0.011 | 0.006 | 55.8% | 0.004 | 36.7% | 0.007 | 66.2% | Negative |
| HN 2 | 10 | 0.014 | 0.011 | 73.8% | 0.009 | 64.3% | 0.014 | 94.8% | Negative |
| HN 3 | 10 | 0.014 | 0.007 | 47.6% | 0.002 | 14.3% | 0.008 | 57.4% | Negative |
| WN 1 | 10 | 0.005 | 0.001 | 20.9% | 0.001 | 20.2% | 0.002 | 37.8% | Negative |
Legend: PC=Positive control, NC=Negative control, MP=Moderate positive, HN=High negative, WN=Weak negative
ﺎﻥ ·
Interpretation of Results at OD 450/630-
Positive Control: ≥ 0.600 Negative Control: < 0.100 Positive: Negative: < 0.150
{13}------------------------------------------------
Meridian
ioscience, Inc
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------510(k) Application | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------The first and the may be and the commend of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the comments of thPremier C. difficile GDI |
|---|---|
| Description: | 510(k) Summary Premier C. difficile GD.------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
| dentification: | JULnanAttachment------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
| Dale:t | February 08, 2011 |
Table 18: Reproducibility data (dual wavelength) - Site 1: CCHMC, Lot 611096.00
| Sample ID | Sample Qual.Result | Day 1Run 1(DH)* | Day 1Run 2(MJG)* | Day 2Run 1(DH)* | Day 2Run 2(MJG)* | Day 3Run 1(DH)* | Day 3Run 2(MJG)* | Day 4Run 1(DH)* | Day 4Run 2(MJG)* | Day 5Run 1(DH)* | Day 5Run 2(MJG)* | Result |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| PC | N/A | 1.684 | 1.968 | 1.827 | 1.663 | 1.432 | 1.757 | 1.770 | 1.992 | 1.857 | 1.854 | Positive |
| NC | 0.011 | 0.009 | 0.012 | 0.013 | 0.012 | 0.013 | 0.016 | 0.017 | 0.013 | 0.018 | Negative | |
| MP 1 | 1.642 | 1.469 | 2.052 | 1.985 | 1.258 | 1.660 | 2.170 | 1.896 | 1.781 | 2.097 | Positive | |
| MP 2 | 1.930 | 1.427 | 1.886 | 2.096 | 2.120 | 1.676 | 2.261 | 2.008 | 1.801 | 1.505 | 2.071 | Positive |
| MP 3 | 1.524 | 2.039 | 2.045 | 1.631 | 1.419 | 2.031 | 1.888 | 2.137 | 1.481 | 2.213 | Positive | |
| LP 1 | 0.510 | 0.840 | 0.716 | 0.622 | 0.412 | 0.681 | 0.483 | 0.670 | 0.529 | 0.722 | Positive | |
| LP 2 | 0.484 | 0.398 | 0.626 | 0.678 | 0.445 | 0.439 | 0.493 | 0.547 | 0.602 | 0.390 | 0.657 | Positive |
| LP 3 | 0.423 | 0.704 | 0.530 | 0.434 | 0.469 | 0.555 | 0.509 | 0.565 | 0.910 | 0.886 | Positive | |
| HN 1 | 0.015 | 0.008 | 0.028 | 0.012 | 0.012 | 0.032 | 0.021 | 0.019 | 0.030 | 0.026 | Negative | |
| HN 2 | 0.003 | 0.024 | 0.007 | 0.027 | 0.053 | 0.014 | 0.016 | 0.020 | 0.035 | 0.028 | 0.027 | Negative |
| HN 3 | 0.019 | 0.015 | 0.018 | 0.021 | 0.015 | 0.017 | 0.026 | 0.040 | 0.025 | 0.133 | Negative | |
| WN 1 | 0.002 | 0.020 | 0.010 | 0.012 | 0.019 | 0.006 | 0.017 | 0.016 | 0.017 | 0.015 | 0.018 | Negative |
| Average high negative value | 0.019 | 0.010 | 0.024 | 0.029 | 0.014 | 0.022 | 0.022 | 0.031 | 0.028 | 0.062 | ||
| Average low positive value | 0.444 | 0.723 | 0.641 | 0.500 | 0.440 | 0.576 | 0.513 | 0.612 | 0.610 | 0.755 | ||
| Percent Correlation | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% | ||
| Correlation of cut off Specimens | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% |
egend: PC=Positive control, NC=Negative control, MP=Moderate positive,
Initials of person performing testing.
First person performing testing.
Interpretation of Results at OD 450/620:
iterpretation of Results at OD 450/630 :
Positive Control: ≥ 0.600
Negative Control: > 0.600
Positive Controli < 0.100
Negative: ≥ 0.150
Negative Control: < 0.100
Positive: >0.150
POSITIVE, 20,150
Negative, 20,150
egative; < 0.150
Page 14 of 17
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Meridian
Bioscience, Inc 发
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | ( C. difficile (510(k) Summary Premier------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | AAAttachment | February 08, 2011 |
|---|---|---|---|
| 510(k) Application Premier C. difficile GD | escription: | Identification: | Date: |
Table 19: Reproducibility data (dual wavelength) - Site 2: SHH, Lot 611096.003
| Day 1 | Day 2 | Day 3 | Day 4 | Day 5 | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Sample ID | Sample Qual.Result | Run 1(DM)* | Run 2(JM)* | Run 1(DM)* | Run 2(JM)* | Run 1(DM)* | Run 2(JM)* | Run 1(DM)* | Run 2(JM)* | Run 1(DM)* | Run 2(JM)* | Result |
| PC | N/A | 1.834 | 1.998 | 1.965 | 1.773 | 1.448 | 1.709 | 1.666 | 1.864 | 1.664 | 1.648 | Positive |
| NC | 0.002 | 0.004 | 0.003 | 0.004 | 0.003 | 0.043 | 0.003 | 0.029 | 0.003 | 0.091 | Negative | |
| MP 1 | 1.882 | 1.487 | 1.955 | 2.060 | 1.412 | 1.940 | 1.804 | 2.314 | 1.157 | 1.705 | Positive | |
| MP 2 | 1.930 | 1.630 | 1.419 | 2.333 | 1.697 | 0.978 | 1.457 | 1.815 | 1.846 | 1.229 | 1.585 | Positive |
| MP 3 | 1.060 | 1.314 | 1.758 | 1.063 | 1.038 | 1.049 | 0.870 | 1.273 | 1.205 | 0.909 | Positive | |
| LP 1 | 0.685 | 0.539 | 0.617 | 0.850 | 0.395 | 0.494 | 0.582 | 0.664 | 0.504 | 0.591 | Positive | |
| LP 2 | 0.484 | 0.533 | 0.323 | 0.779 | 0.736 | 0.429 | 0.538 | 0.544 | 0.644 | 0.465 | 0.535 | Positive |
| LP 3 | 0.424 | 0.474 | 0.755 | 0.825 | 0.493 | 0.513 | 0.483 | 0.638 | 0.485 | 0.546 | Positive | |
| HN 1 | 0.008 | 0.004 | 0.004 | 0.044 | 0.005 | 0.003 | 0.004 | 0.004 | 0.003 | 0.004 | Negative | |
| HN 2 | 0.003 | 0.009 | 0.005 | 0.004 | 0.033 | 0.003 | 0.003 | 0.005 | 0.006 | 0.002 | 0.006 | Negative |
| HN 3 | 0.009 | 0.005 | 0.004 | 0.065 | 0.003 | 0.005 | 0.004 | 0.005 | 0.002 | 0.005 | Negative | |
| WN 1 | 0.002 | 0.003 | 0.002 | 0.004 | 0.004 | 0.003 | 0.003 | 0.003 | 0.003 | 0.007 | 0.002 | Negative |
| Average high negative value | 0.009 | 0.005 | 0.004 | 0.047 | 0.004 | 0.004 | 0.004 | 0.005 | 0.002 | 0.005 | ||
| Average low positive value | 0.547 | 0.445 | 0.717 | 0.804 | 0.439 | 0.515 | 0.536 | 0.649 | 0.485 | 0.557 | ||
| Percent Correlation | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% | ||
| Correlation of cut off Specimens | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% |
gend: PC=Positive control, NC=Nega
nitials of person performing testing.
umbers of person performing testing.
Interpretation of Results at OD 450/630:
Positive Control: >0.500
lnterpretation of Results at OD ๙๑๑๑๑๑๑๑๑
Positive Control: ≥ 0.600
Negative Control: ≥ 0.600
Negative Control: < 0.100
Negative:
{15}------------------------------------------------
Meridian
Bioscience, Inc. িনিট
| 510(k) Application Premier C. difficile GDI | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------A C A C L B . L . L |
|---|---|
| Description: | 510(k) Summary Premier C. difficile GDI |
| dentification | ttachment |
| Date:t | 9044February 08, 201 |
Table 20: Reproducibility data (dual wavelength) - Site 3: NCH, Lot 611096.005
| Sample ID | Sample Qual.Result | Day 1Run 1(LS)* | Day 1Run 2(KE)* | Day 2Run 1(LS)* | Day 2Run 2(KE)* | Day 3Run 1(LS)* | Day 3Run 2(KE)* | Day 4Run 1(LS)* | Day 4Run 2(KE)* | Day 5Run 1(LS)* | Day 5Run 2(KE)* | Result |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| PC | N/A | 1.911 | 2.311 | 2.075 | 2.496 | 2.587 | 2.063 | 2.123 | 2.163 | 1.476 | 2.071 | Positive |
| NC | 0.003 | 0.004 | 0.004 | 0.003 | 0.006 | 0.004 | 0.003 | 0.003 | 0.003 | 0.003 | Negative | |
| MP 1 | 1.951 | 2.322 | 2.080 | 2.762 | 2.146 | 2.076 | 2.099 | 2.21 | 1.371 | 2.238 | Positive | |
| MP 2 | 1.930 | 1.711 | 2.514 | 2.205 | 2.538 | 2.411 | 2.212 | 2.136 | 2.304 | 1.535 | 2.038 | Positive |
| MP 3 | 1.621 | 2.784 | 1.842 | 2.321 | 2.531 | 1.990 | 2.317 | 2.292 | 1.532 | 0.802 | Positive | |
| LP 1 | 0.533 | 0.855 | 0.747 | 1.005 | 0.858 | 0.823 | 0.794 | 0.855 | 0.476 | 0.710 | Positive | |
| LP 2 | 0.484 | 0.539 | 0.995 | 0.702 | 0.934 | 0.932 | 0.869 | 0.780 | 0.922 | 0.521 | 0.790 | Positive |
| LP 3 | 0.497 | 0.950 | 0.770 | 0.963 | 0.983 | 0.734 | 0.689 | 0.917 | 0.487 | 0.802 | Positive | |
| HN 1 | 0.008 | 0.018 | 0.022 | 0.018 | 0.004 | 0.005 | 0.004 | 0.015 | 0.002 | 0.012 | Negative | |
| HN 2 | 0.003 | 0.010 | 0.021 | 0.014 | 0.049 | 0.005 | 0.006 | 0.007 | 0.019 | 0.003 | 0.009 | Negative |
| HN 3 | 0.006 | 0.022 | 0.030 | 0.019 | 0.008 | 0.006 | 0.010 | 0.016 | 0.008 | 0.013 | Negative | |
| WN 1 | 0.002 | 0.005 | 0.003 | 0.009 | 0.003 | 0.005 | 0.007 | 0.004 | 0.004 | 0.005 | 0.004 | Negative |
| Average high negative value | 0.008 | 0.020 | 0.022 | 0.029 | 0.006 | 0.006 | 0.007 | 0.017 | 0.004 | 0.011 | ||
| Average low positive value | 0.523 | 0.933 | 0.740 | 0.967 | 0.924 | 0.809 | 0.754 | 0.898 | 0.495 | 0.767 | ||
| Percent Correlation | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% | ||
| Correlation of cut off Specimens | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% |
Neak nega Legend: PC=Positive control, NC=Negative control, MP=Moderate positive, LP=Low positive, HN=High negative,
- Initials of person performing testing.
limits of person performing testing
lnterpretation of Results at OD «so/eso:
Positive Control: ≥ 0.600
Negative Control: ≥ 0.600
Negative :
Page 16 of 17
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Image /page/16/Picture/0 description: The image shows the logo for Meridian Bioscience, Inc. The logo consists of a globe graphic on the left, followed by the word "Meridian" in a bold, sans-serif font. Below "Meridian" is the text "Bioscience, Inc." in a smaller, bold, sans-serif font. A horizontal line separates "Meridian" from "Bioscience, Inc."
| 510(k) Application Premier C. difficile GDH | |
|---|---|
| Description: | 510(k) Summary Premier C. difficile GDH |
| Identification: | Attachment 002 |
| Date: | February 08, 2011 |
Conclusions
The Premier C. difficile GDH assay can be used to screen human stool samples for C. difficile glutamate dehydrogenase and can be considered substantially equivalent to the reference method and predicate device.
{17}------------------------------------------------
Image /page/17/Picture/1 description: The image shows the logo for the Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES.USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird with its wings spread, facing to the right. The image is in black and white.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Meridian Bioscience, Inc. c/o Ms. Susan Bogar Product Quality Assurance Manager 3471 River Hills Drive Cincinnati, OH 45244
MAY - 3 2011
Re: K110620
Trade/Device Name: Premier™ C. difficile GDH Assay Regulation Number: 21 CFR 866.2660 Regulation Name: Microorganism differentiation and identification device. Regulatory Class: Class I Product Code: MCB Dated: March 2, 2011 Received: March 3, 2011
Dear Ms. Bogar:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter
{18}------------------------------------------------
Page 2 - Ms. Susan Bogar
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) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Sallastors
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
{19}------------------------------------------------
Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Premier C. difficile GDH
Indications for Use:
Premier C. difficile GDH is a qualitative enzyme immunoassay screening test to detect Clostridium difficile antigen, glutamate dehydrogenase, in fecal specimens from symptomatic persons suspected of having C. difficile infection (CDI). This test does not distinguish between toxigenic and non-toxigenic strains of C. difficile. Samples from symptomatic patients that produce positive results with this test must be further tested with an assay designed to detect toxigenic C. difficile strains and assist with the diagnosis of CDI.
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 In Vitro Diagnostic Devices (OIVD)
Kuddie Poole
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K118620
Page 1 of
§ 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.