(151 days)
ImmunoCard C. difficile GDH is a rapid qualitative enzyme immunoassay screening test to detect Clostridium difficile antigen, glutamate dehydrogenase, in fecal specimens from persons suspected of having C. difficile infection (CDI). This test does not distinguish between toxigenic and non-toxigenic strains of C. difficile. Samples from 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.
ImmunoCord C. difficile GDH is a rapid qualitative enzyme immunoassay screening test to detect Clostridium difficile antigen, glutamate dehydrogenase (GDH), in fecal specimens from persons suspected of having C. difficile infection. The assay consists of ImmunoCard C. difficile GDH Test Cards containing immobilized polyclonal anti-C. difficile GDH antibodies, ImmunoCard C. difficile GDH Positive Control, ImmunoCard C. difficile GDH Sample Diluent/Negative Control, ImmunoCard C. difficile GDH Enzyme Conjugate, ImmunoCard Wash Buffer I, and ImmunoCard Substrate I.
Here's an analysis of the ImmunoCard C. difficile GDH device based on the provided document, addressing the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for sensitivity and specificity are not explicitly stated as distinct "acceptance criteria" beyond the presented performance metrics. However, based on the desire to demonstrate substantial equivalence, the reported performance of the ImmunoCard C. difficile GDH is compared to bacterial culture as the reference.
| Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Sensitivity | Sufficiently high to detect C. difficile GDH antigen (compared to culture) | 97.6% (95% CI: 93.3 – 99.2%) |
| Specificity | Sufficiently high to differentiate true positives from negatives (compared to culture) | 87.0% (95% CI: 84.6 – 90.1%) |
| Correlation | Overall agreement with reference method (culture) | 88.4% (95% CI: 86.2 – 90.3%) |
| Reproducibility (Overall Correlation) | High agreement across sites and operators | 99.7% (98.1 – 99.9%) |
(Note: The document implies these performance levels are the acceptance criteria for regulatory submission as they are the key clinical performance results presented for review.)
2. Sample size used for the test set and the data provenance
- Sample Size (Clinical Test Set): 975 qualified patient samples.
- Data Provenance:
- Country of Origin: United States (Midwestern, Southwestern, and Western regions).
- Retrospective or Prospective: Prospectively collected.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not explicitly state the number or qualifications of "experts" used to establish the ground truth. The ground truth was established by bacterial C. difficile culture, which is a laboratory-based method. The performance of the culture itself would typically be overseen by trained laboratory personnel, but no specific "experts" for truth adjudication are mentioned outside of the methodology.
4. Adjudication method for the test set
There is no mention of an adjudication method like 2+1 or 3+1 for the clinical test set. The ImmunoCard C. difficile GDH assay results were directly compared to the results of bacterial C. difficile culture.
5. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This is not an AI-based device, but rather a rapid qualitative enzyme immunoassay (EIA) intended for screening.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This question is not applicable in the context of this device. The ImmunoCard C. difficile GDH is itself a "standalone" diagnostic test (an EIA) that produces a visual read (positive/negative) which is then interpreted by a human. There is no separate "algorithm only" performance reported, as the human interpretation of the visual reaction is an inherent part of the device's function.
7. The type of ground truth used
The type of ground truth used for the clinical performance comparison was bacterial C. difficile culture.
8. The sample size for the training set
The document does not explicitly mention a "training set" in the context of machine learning or AI. This is a traditional immunoassay. However, if we interpret "training set" as the samples used for initial development and optimization of the assay prior to clinical validation, that information is not detailed here. The analytical studies (sensitivity, interference, cross-reactivity, strain reactivity) involved various spiked and natural samples, but these are not referred to as a "training set" in the sense of a machine learning model.
9. How the ground truth for the training set was established
As there is no distinct "training set" described in the machine learning sense, the establishment of its ground truth is not applicable. For the analytical studies (e.g., sensitivity, cross-reactivity), the ground truth was established by:
- Known concentrations of C. difficile GDH antigen (for analytical sensitivity/limit of detection).
- Known presence or absence of specific microorganisms/substances (for interference and cross-reactivity studies).
- Confirmed C. difficile stock cultures (for strain reactivity).
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DEC 1 6 2011
| K112048: Request for Additional Information |
|---|
| Attachment 009: Revised 510(k) Summary |
| Product Information: | ImmunoCard C. difficile GDH |
|---|---|
| Date: | November 29, 2011 |
| Document Revision: | 002 |
| 510(k) number: | |
|---|---|
| ---------------- | -- |
Date of Preparation: July 15, 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: | ImmunoCard C. difficile GDH |
| Common name: | Enzyme Immunoassay for C. difficile Common Antigen |
| Classification: | Antigen, C. difficile |
| MCB, CFR Section 866.2660 | |
| Predicate device: | K053572: TECHLAB C. DIFF QUIK CHEK® |
| Reference comparator: | Bacterial culture |
Description of the device:
ImmunoCord C. difficile GDH is a rapid qualitative enzyme immunoassay screening test to detect Clostridium difficile antigen, glutamate dehydrogenase (GDH), in fecal specimens from persons suspected of having C. difficile infection. The assay consists of ImmunoCard C. difficile GDH Test Cards containing immobilized polyclonal anti-C. difficile GDH antibodies, ImmunoCard C. difficile GDH Positive Control, ImmunoCard C. difficile GDH Sample Diluent/Negative Control, ImmunoCard C. difficile GDH Enzyme Conjugate, ImmunoCard Wash Buffer I, and ImmunoCard Substrate I.
Intended Use:
ImmunoCord C. difficile GDH is a rapid qualitative enzyme immunoassay screening test to detect Clostridium difficile antigen, glutamate dehydrogenase, in fecal specimens suspected of having C. difficile infection (CDI). This test does not distinguish between toxigenic strains of C. difficile. Samples from 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: MeridianBioscience, Inc. logo | K112048: Request for Additional InformationAttachment 009: Revised 510(k) Summary | |||
|---|---|---|---|---|
| Product Information: | ImmunoCard C. difficile GDH | |||
| Date: | November 29, 2011 | Document Revision: | 002 |
Table 1: Comparison to predicate device.
·
| Characteristic | ImmunoCard C. difficile GDH | TECHLAB C. DIFF QUIK CHEK® |
|---|---|---|
| Test Format | Rapid EIA | Rapid EIA |
| 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 | ImmunoCard C. difficile GDH Test CardsImmunoCard C. difficile GDH EnzymeConjugateImmunoCard Wash Buffer IImmunoCard Substrate IImmunoCard C. difficile GDH SampleDiluent/Negative ControlImmunoCard C. difficile GDH PositiveControlPlastic transfer pipettes | Membrane DevicesEnzyme ConjugateWash BufferSubstrateDiluentPositive ControlDisposable plastic transfer pipettes |
| Diagnostic Marker | ||
| Antibody | Yes | Yes |
| Antibody Sources | ||
| Test Card | Rabbit polyclonal | Polyclonal |
| Enzyme Conjugate | Mouse monoclonal | Mouse monoclonal |
| Sample Preparation | ||
| Unpreserved liquid/semi-solidstool | 1. 25 µL of thoroughly mixed stool into 200 µL Sample Diluent. Vortex for 10 seconds.2. Add 3 drops of Enzyme Conjugate to the sample.3. Incubate diluted sample at 20-26 C for 15 minutes. | 1. 1 drop of Enzyme Conjugate into 500 µL Diluent2. 25 µL specimen into Diluent-Conjugate mixture. Mix with transfer pipette. |
| Solid stool | 1. Add ~2mm diameter portion of thoroughly mixed stool into 200 µL Sample Diluent and vortex for 10 seconds.2. Add 3 drops of Enzyme Conjugate to the sample. | 1. Add 500 µL Diluent to a clean tube.2. Add 1 drop Conjugate to the Diluent tube.3. Transfer ~2mm diameter portion of specimen into the Diluent-Conjugate mixture and emulsify the specimen using the applicator stick. |
| Testing Time | Approximately 25 minutes | Approximately 25 minutes |
| Equipment | ||
| General Laboratory Equipment | VortexInterval timerApplicator sticksSmall test tubesDisposable latex gloves | Pipettor and tipsVortexInterval timerApplicator sticksSmall test tubesDisposable latex gloves |
| Reading Method | Visual | Visual |
.
{2}------------------------------------------------
| Image: Meridian Bioscience, Inc. logo | K112048: Request for Additional InformationAttachment 009: Revised 510(k) Summary | ||
|---|---|---|---|
| Product Information: | ImmunoCard C. difficile GDH | ||
| Date: | November 29, 2011 | DocumentRevision: 002 |
Table 1: Comparison to predicate device contd.
| Results Interpretation | ||
|---|---|---|
| Visual Read | Negative: Blue color in the CONTROLreaction port only.Positive: Blue color in the TEST andCONTROL reaction ports.Invalid: No detectable blue color in theCONTROL reaction port or a blue ring onthe plastic frame surrounding the TEST portduring the test procedure. | Negative: Single blue line visible on theCONTROL side of the reaction window only.Positive: Blue line visible on the TEST sidealong with a blue line visible on theCONTROL side.Invalid: Single line visible on the TEST side ofthe reaction window or no lines visible in thereaction window. |
Performance Comparison, Non-Clinical Tests
Analytical Sensitivity
Sensitivity studies were designed to determine with 95% confidence 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: 10 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 infection were added to a natural negative and a contrived positive stool sample. The contrived positive sample was prepared by spiking a confirmed negative sample with C. difficile GDH at 10 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 phosphatebuffered 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 ImmunoCard 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 10 3 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-Bismol® (Bismuth subsalicylate) (0.87 mg/mL), Polyethylene glycol (79.05 mg/mL), Prilosec® (0.5 mg/mL), Simethicone (0.625 mg/mL), Tagamet® (Cimetidine) (0.5 mg/mL), Tums® (Calcium carbonate) (5.0 mg/ml), Vancomycin HCl (2.5 mg/mL), Whole blood (40%), 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 pooled negative and contrived positive sample. The contrived positive specimen was 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 GDH at 10 ng/mL, the limit of detection for this assay. Potentially cross-reactive microorganisms were added at a final concentration of 1.2 x 10 ° CFU/mL (bacteria or fungi) or a final concentration greater than 1 x 10 °TCIDso /mL (viruses). Dilution
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| MeridianBioscience, Inc. | K112048: Request for Additional InformationAttachment 009: Revised 510(k) Summary | ||
|---|---|---|---|
| Product Information: ImmunoCard C. difficile GDH | |||
| Date: | November 29, 2011 | DocumentRevision: | 002 |
controls for each sample were prepared by adding a saline solution in place of the potentially cross-reactive organisms.
The following microorganisms, at the indicated concentrations, do not interfere with ImmunoCard C. difficile GDH test results: Aeromonas hydrophila, Bacillus subtilis, Bacteroides fragilis, Campylobocter coli, Campylobacter fetus, Campylobacter jejuni, Candida albicans, Citrobacter freundii, Clostridium bifermentans, Clostridium butyricum, Clostridium, Clostridium histolyticum, Clostridium novyi, Clostridium perfringens, Clostridium septicum sordellii, Clostridium sporogenes, Clostridium tetani, Enterobacter aerogenes, Enterobacter cloacoe, Enterococcus faecalis, Escherichia coli, Escherichia coli 0157:H7, Escherichia hermannii, Escherichia fergusonii, Klebsiella pneumoniae, Loctococcus lactis, Listeria monocytogenes, Peptostreptococcus anaerobius, Plesiomonas shigelloides, Porphyromonas osacharolytica, Proteus vulgaris, Pseudomonos peudomonos fluorescens, Salmonella Group B, Salmonella Group C, Salmonella Group D, Salmonella Group E, Serratia marcescens, Shigella boydii, Shigella flexneri, Shigella sonnei, Staphylococus aureus, Staphylococcus epidermidis, Vibrio parahaemolyticus, Yersinia enterocolitico, Adenovirus Type 40, Adenovirus Type 41, Coxsackievirus Strain 30, Rotavirus Strain WA.
Stool spiked with Staphylococus aureus (Cowan Strain I) were found to be cross-reactive with ImmunoCord C. difficile GDH.
Strain Reactivity
The following C. difficile stock cultures from different sources were tested and produced positive reactions at a concentration of 1.2 x 107 CFU/mL with the ImmunoCard C. difficile GDH assay:
Toxigenic C. difficile strains: 8864, 10463, 43598, 2004111, 2004118, 2004205, 2004206, 2005070, 2005257, 2005325, 2006240, 2007431, 2007858, 2008016, 2008029, 2008162, 2008188, 2008341, 2008351, 2009018, 2009066, 2009099, 2009132, 2009155, 2009277, B1, B117, B18, BK6, CF1, G1, J7, K12, YI
Non-toxigenic C. difficile strains: 11186, 234, 586, 611, 620, 2C165, C122, UNC19904, X15076
Performance Comparison, Clinical Tests
Clinical trials for the ImmunoCard C. difficile GDH assay were conducted April - June 2011. Performance characteristics of the ImmunoCard C. difficile GDH assay were determined by comparison to bacterial C. difficile culture. Independent clinical test sites located in the Midwestern, Southwestern, and Western regions of the United States evaluated a total of 975 qualified patient samples were prospectively collected. Samples were collected from 446 (45.7%) males and categorized as solid (17.1%), semi-solid (50.8%), bloody (0.5%) and watery (31.5%). The age groups of patients range from 14 days to 111 years. No differences in test performance were observed based on patient age, gender, or geographic location. Overall sensitivity was determined to be 97.6% (95% Cl: 93.3 – 99.2%). Overall specificity was determined to be 87.0% (95% Cl: 84.6 – 90.1%). Subsequent tables show overall assay performance as well as performance by clinical site and patient age.
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| MeridianBioscience, Inc. | K112048: Request for Additional InformationAttachment 009: Revised 510(k) Summary | ||
|---|---|---|---|
| Product Information: ImmunoCard C. difficile GDH | |||
| Date: | November 29, 2011 | Document Revision: | 002 |
Table 2: Performance Characteristics for ImmunoCard C. difficile GDH
| ImmunoCard C. difficile GDH | ||||
|---|---|---|---|---|
| Culture | Positive | Negative | Total | |
| Positive | 124 | 3 | 127 | |
| Negative | 110 | 738 | 848 | |
| Total | 234 | 741 | 975 | |
| 95% CI | ||||
| Sensitivity | 124/127 | 97.6% | 93.3 - 99.2% | |
| Specificity | 738/848 | 87.0% | 84.6 - 90.1% | |
| Correlation | 862/975 | 88.4% | 86.2 - 90.3% |
Table 3: Performance Characteristics by Site
| Clinical TrialSite | ImmunoCardC. difficileGDH/Culture | % Sensitivity | 95% CI | ImmunoCardC. difficileGDH/Culture | % Specificity | 95% CI |
|---|---|---|---|---|---|---|
| Site 1 | 32/32 | 100.0% | 89.3 - 100.0% | 165/205 | 80.5% | 74.5 - 85.3% |
| Site 2 | 39/41 | 95.1% | 83.9 - 98.7% | 257/290 | 88.6% | 84.4 - 91.8% |
| Site 3 | 35/36 | 97.2% | 85.8 - 99.5% | 140/168 | 83.3% | 77.0 - 88.2% |
| Site 4 | 8/8 | 100.0% | 67.6 - 100.0% | 76/80 | 95.0% | 87.8 - 98.0% |
| Site 5 | 10/10 | 100.0% | 72.2 - 100.0% | 100/105 | 95.2% | 89.3 - 97.9% |
Table 4: Performance Characteristics by Patient Age
| Patient Age | ImmunoCardC. difficileGDH/Culture | Sensitivity % | 95% Cl | ImmunoCardC. difficileGDH/Culture | Specificity % | 95% Cl |
|---|---|---|---|---|---|---|
| < 5 years | 41/41 | 100.0% | 91.4 - 100.0% | 129/168 | 76.8% | 69.8 -- 82.5% |
| 6 - 21 years | 30/31 | 96.8% | 83.8 - 99.4% | 179/208 | 86.1% | 80.7 - 90.1% |
| 22-59 years | 21/22 | 95.5% | 78.2 - 99.2% | 213/233 | 91.4% | 87.1 - 94.4% |
| ≥ 60 years | 32/33 | 97.0% | 84.7- 99.5% | 217/239 | 90.8% | 86.5 - 93.8% |
{5}------------------------------------------------
| K112048: Request for Additional InformationAttachment 009: Revised 510(k) Summary | ||
|---|---|---|
| Product Information: | ImmunoCard C. difficile GDH | |
| Date: | November 29, 2011 | Document Revision: 002 |
Reproducibility
Reproducibility panels were performed by three clinical laboratories using blinded 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 overall correlation for the ImmunoCard C. difficile GDH reproducibility study was 99.7% (98.1 – 99.9%). The correlation between expected and achieved results for the moderate positive and negative specimens was 100.0% (98.2 – 100.0%). The correlation for the high negative specimen was 98.9% (94.0 – 99.8%). Tables 5-7 contain the reproducibility data for the 3 sites.
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002 Document Revision ImmunoCard C. difficile GD ovember 29, 201 112048: Request for Additional In. . . .nation
attachment 009: Revised 510(k) Summary_________________________________________________________________________________________ Date:
َable 5: Site 1 Reproducibility Data, Lot 716050B0
Meridian
ioscience, Inc
| Sample ID | Sample Qual.Result | Day 1Run 1(EK)* | Day 1Run 2(EEG)* | Day 2Run 1(EK)* | Day 2Run 2(EEG)* | Day 3Run 1(EK)* | Day 3Run 2(EEG)* | Day 4Run 1(EK)* | Day 4Run 2(EEG)* | Day 5Run 1(EK)* | Day 5Run 2(EEG)* | Sample ID | Sample Qual.Result | Day 1Run 1(JM)* | Day 1Run 2(DS)* | Day 2Run 1(JM)* | Day 2Run 2(DS)* | Day 3Run 1(JM)* | Day 3Run 2(DS)* | Day 4Run 1(JM)* | Day 4Run 2(DS)* | Day 5Run 1(JM)* | Day 5Run 2(DS)* | Sample ID | Sample Qual.Result | Day 1Run 1(KE)* | Day 1Run 2(LS)* | Day 2Run 1(KE)* | Day 2Run 2(LS)* | Day 3Run 1(KE)* | Day 3Run 2(LS)* | Day 4Run 1(KE)* | Day 4Run 2(LS)* | Day 5Run 1(KE)* | Day 5Run 2(LS)* | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Positive Control | Positive | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Positive Control | Positive | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Positive Control | Positive | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | |
| Negative Control | Negative | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Negative Control | Negative | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Negative Control | Negative | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg | |
| Moderate Positive 1 | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Moderate Positive 1 | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Moderate Positive 1 | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | ||||
| Moderate Positive 2 | Positive | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Moderate Positive 2 | Positive | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Moderate Positive 2 | Positive | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | |
| Moderate Positive 3 | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Moderate Positive 3 | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Moderate Positive 3 | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | ||||
| Low Positive 1 | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Low Positive 1 | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Low Positive 1 | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | ||||
| Low Positive 2 | Positive | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Low Positive 2 | Positive | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Low Positive 2 | Positive | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | |
| Low Positive 3 | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Low Positive 3 | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Low Positive 3 | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | ||||
| High Negative 1 | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg | High Negative 1 | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg | High Negative 1 | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg | ||||
| High Negative 2 | Negative | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg | High Negative 2 | Negative | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg | High Negative 2 | Negative | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg | |
| High Negative 3 | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg | High Negative 3 | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg | High Negative 3 | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg | ||||
| Negative 1 | Negative | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Negative 1 | Negative | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Negative 1 | Negative | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg | |
| Percent Correlation | 100.0% | 100.0% | 90.0% | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% | Percent Correlation | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% | 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% | 83.3% | 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% | 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: Pos - Positive; Neg - Negative
gend: Pos = Positive; Neg = Negat
hitials of person performing testin
Interpretation of Results:
Result: Blue color in the TEST file
Release Control and Subordinates.
Reaction Control: Results
nterpretation of Results:
Positive Test Result: Blue color in the TEST and Control only:
Regaine Test Result: Blue color in the CONTROL reaction port or a blue ine on the the test procedure
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002 Document Revision mmunoCard C. difficile GD ovember 29, 201 2048: Request for Additional Informat
achment 009: Revised 510(k) Summary roduct Information Date:
able 6: Site 2 Reproducibility Data, Lot 716050B0
Meridian
ioscience, Inc
Legend: POS = Positive; Neg = Negative
end: Pos = Positive; Neg = Negati
itials of person performing testin
Interpretation of Results:
Positive Test Result: Blue color in the TEST and CONTROL reaction ports.
Negative Test Result: Blue color in the CONTROL reaction port only.
hterpretation of Results:
Positive Test Result: Blue Color in the TCS Tar CONTROL reaction ports.
Negative Test Result: No decction port only.
Invalit Test Results: be decet the test procedure Page 8 of 9
{8}------------------------------------------------
Meridian
ioscience, Inc
ImmunoCard C. difficile GD K112048: Request for Additional In-...nation
Attachment 009: Revised 510(k) Summary___________________________________________________________________________________________ 002
ocument Revisio
ovember 29, 201
Date:
able 7: Site 3 Reproducibility Data, Lot 716050B0
ﺮ ﺣﺠﺮ
end: Pos = Positive; Neg = Negat
hitials of person performing testin
Number of searches per person per time period resulting in a simulated phishing landing.
Interpretation of Results:
→ Result: Positive
→ Color: Blue
→ Test is INVALID and control portion is ABSENT. Repeat test immediately.
informational
React component
nterpretation of Results:
Positive Test Result: Blue color in the Testion ports.
Negative Test Result: Blue color only.
noldi Test Result: No decetable blue colorio only.
wal the test procedure Page 9 of 9
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/9/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The bird is positioned to the right of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
10903 New Hampshire Avenue Silver Spring, MD 20993
Meridian Bioscience, Inc. c/o Susan Bogar Product Quality Assurance Manager 3471 River Hills Drive Cincinnati, OH 45244
DEC 1 6 2011
Re: K112048
Trade/Device Name: ImmunoCard™ C. difficile GDH Assay Regulation Number: 21 CFR § 866.2660 Regulation Name: Microorganism Differentiation and Identification Device Regulatory Class: Class I Product Codes: MCB Dated: December 7, 2011 Received: December 8, 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
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requirements as set forth in the quality systems (OS) 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) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Salyattgus
Sally A. Hojvat, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostic Devices Evaluation and Safety Center for Devices and Radiological Health
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Indications for Use Form
510(k) Number (if known): __ Ki 1 20 48
ImmunoCard C. difficile GDH Device Name:
Indications for Use:
ImmunoCard C. difficile GDH is a rapid qualitative enzyme immunoassay screening test to detect Clostridium difficile antigen, glutamate dehydrogenase, in fecal specimens from persons suspected of having C. difficile infection (CDI). This test does not distinguish between toxigenic and non-toxigenic strains of C. difficile. Samples from 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 × (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)
Eucalita Poole
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety.
510(k) K112048
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.