(61 days)
K030992: TECHLAB C. DIFF CHEK™ - 60 ELISA
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No
The device description and performance studies describe a standard enzyme immunoassay, with no mention of AI or ML techniques.
No.
The device is an in vitro diagnostic test designed to detect C. difficile antigen for diagnostic purposes, not to provide therapy or treatment.
Yes
The device is described as an "enzyme immunoassay screening test to detect Clostridium difficile antigen...in fecal specimens from symptomatic persons suspected of having C. difficile infection (CDI)," indicating its use in identifying a condition in patients.
No
The device description explicitly lists physical components such as microwells, enzyme conjugate, wash buffer, substrate, and stop solution, indicating it is a hardware-based immunoassay kit, not software only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's a "qualitative enzyme immunoassay screening test to detect Clostridium difficile antigen... in fecal specimens from symptomatic persons suspected of having C. difficile infection (CDI)." This describes a test performed in vitro (outside the body) on a biological sample (fecal specimen) to provide information for the diagnosis of a disease (CDI).
- Device Description: The description details the components of the assay, which are reagents and materials used to perform a test on a sample. This is characteristic of an IVD.
- Anatomical Site: The test is performed on "Fecal specimens," which are biological samples collected from the body.
- Performance Studies: The document describes clinical trials and performance characteristics (sensitivity, specificity) determined by testing patient samples. This is standard for evaluating the performance of an IVD.
- Predicate Device: The mention of a "Predicate Device" (K030992: TECHLAB C. DIFF CHEK™ - 60 ELISA) which is also an ELISA for C. difficile, further indicates that this device falls within the category of IVDs.
The information provided aligns perfectly with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / 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 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.
Product codes (comma separated list FDA assigned to the subject device)
MCB
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
22 days to 99 years
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Comparison, Non-clinical Tests included Analytical Sensitivity, Interference Testing, Cross-reactivity Study, and Strain Reactivity tests.
Analytical 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 were tested for interference at specified saturated solvent/diluent concentrations. Substances that did not interfere include 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: Various microorganisms were tested at final concentrations of 1.2 x 10° CFU/mL (bacteria or fungi) or greater than 1 x 10° TC/Dg/mL (viruses). Microorganisms that did not interfere include 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, Vibrio parahaemolyticus, Yersinio enterocolitica, Adenovirus Type 41, Coxsackievirus Strain B4, Echovirus Strain 11, Rotavirus Strain WA. Staphlococus aureus (Cowan strain I) and Clostridium sporogenes were found to be cross-reactive.
Strain Reactivity: C. difficile stock cultures from different sources produced positive reactions at a concentration of 5.7 x 10' cells/mL.
Performance Comparison, Clinical Tests:
Sample Size: 733 qualified patient samples.
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%).
Reproducibility: Reproducibility panels were performed by three clinical laboratories using blind coded panels. 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. 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Overall Sensitivity: 92.3% (108/117)
Overall Specificity: 95.8% (590/616)
Overall Correlation: 95.2% (698/733)
Sensitivity for patients less than 2 years of age: 91.3% (21/23)
Specificity for patients less than 2 years of age: 94.7% (54/57)
Correlation for patients less than 2 years of age: 93.8% (75/80)
Sensitivity for patients 2 years of age and greater: 92.6% (87/94)
Specificity for patients 2 years of age and greater: 95.9% (536/559)
Correlation for patients 2 years of age and greater: 95.4% (623/653)
Reproducibility of the assay is 100% for moderate positive, high negative, and negative samples.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K030992: TECHLAB C. DIFF CHEK™ - 60 ELISA
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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.
0
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.
1
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 glutamate | |
| dehydrogenase | Clostridium difficile glutamate | |
| dehydrogenase | ||
| Screening, Diagnostic, or | ||
| Identification Test | Screening | Screening |
| Specimen Types | ||
| Human Stool Unpreserved | Yes | Yes |
| Reagents/Components | Premier C. difficile GDH Microwells | |
| 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 | ||
| Premier C. difficile GDH Positive Control | Microassay plate | |
| Enzyme Conjugate | ||
| 20X Wash Buffer | ||
| Substrate | ||
| Stop Solution | ||
| Diluent | ||
| Positive 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-solid | ||
| stool | 50 µL of thoroughly mixed stool into | |
| 200 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 | Spectrophotometer | |
| StatFax™- 2200 Incubator/Shaker | ||
| (optional) | ||
| Semiautomated Microplate Washer | ||
| (optional) | Spectrophotometer | |
| Reading Method | Spectrophotometric | Visual |
| Spectrophotometric | ||
| Results Interpretation | ||
| Single Wavelength ( A450 nm) | Negative: 12 years to 21 | |
| years | 10/13 | 76.9% |
| >21 years | 50/53 | 94.3% |
| Not Defined | 0/0 | N/A |
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.
6
| 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).
| Panel
Members | Sample
N | Grand
Mean 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: ﺎﻥ ·
Interpretation of Results at OD 450/630-
Positive Control: ≥ 0.600 Negative Control: 0.600
Positive Controli 0.150
POSITIVE, 20,150
Negative, 20,150
egative; 0.500
lnterpretation of Results at OD ๙๑๑๑๑๑๑๑๑
Positive Control: ≥ 0.600
Negative Control: ≥ 0.600
Negative Control: