(151 days)
K053572: TECHLAB C. DIFF QUIK CHEK®
Not Found
No
The device description and performance studies describe a standard enzyme immunoassay, with no mention of AI or ML components.
No.
The device is a diagnostic test for detecting Clostridium difficile antigen, not a treatment device.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is a "screening test to detect Clostridium difficile antigen... in fecal specimens from persons suspected of having C. difficile infection (CDI)" and that positive results "must be further tested with an assay designed to detect toxigenic C. difficile strains and assist with the diagnosis of CDI." This indicates its role in identifying or aiding in the identification of a disease.
No
The device description explicitly lists physical components such as test cards, controls, diluent, conjugate, wash buffer, and substrate, indicating it is a hardware-based immunoassay kit, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's a "rapid qualitative enzyme immunoassay screening test to detect Clostridium difficile antigen... in fecal specimens from 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, including test cards, controls, diluent, conjugate, wash buffer, and substrate. These are all typical components of an in vitro diagnostic test kit.
- Anatomical Site: The test is performed on "Fecal specimens," which are biological samples collected from the body for in vitro analysis.
- Performance Studies: The document describes clinical trials where the device's performance was evaluated by testing patient samples in vitro and comparing the results to a reference method (bacterial culture).
- Key Metrics: The reporting of sensitivity, specificity, and correlation are standard metrics used to evaluate the performance of in vitro diagnostic tests.
- Predicate Device: The mention of a predicate device (TECHLAB C. DIFF QUIK CHEK®) with a K number (K053572) indicates that this device is being compared to another legally marketed in vitro diagnostic device.
- Reference Device: The use of "Bacterial culture" as a reference device further confirms that this is an in vitro diagnostic test being evaluated against a standard laboratory method.
All of these points strongly indicate that the ImmunoCard C. difficile GDH is an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
MCB
Device Description
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.
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
The age groups of patients range from 14 days to 111 years.
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Comparison, Non-Clinical Tests:
Analytical Sensitivity: The analytical limit of detection (LOD) of C. difficile GDH antigen diluted in a human stool matrix was determined to be 10 ng/mL with 95% confidence based on 45 replicates.
Interference Testing: No interference was found with specified concentrations of Barium sulfate, Fecal fat, Hemoglobin, Imodium AD (Loperamide HCl), Kaopectate (Bismuth subsalicylate), Metronidazole, Mucin, Mylanta (Aluminum hydroxide w/ magnesium hydroxide), Pepto-Bismol (Bismuth subsalicylate), Polyethylene glycol, Prilosec, Simethicone, Tagamet (Cimetidine), Tums (Calcium carbonate), Vancomycin HCl, Whole blood, White blood cells.
Cross-reactivity Study: No interference was observed from a list of various bacteria, fungi, and viruses at specified concentrations. However, stool spiked with Staphylococus aureus (Cowan Strain I) were found to be cross-reactive.
Strain Reactivity: The ImmunoCard C. difficile GDH assay produced positive reactions at 1.2 x 10^7 CFU/mL for various toxigenic and non-toxigenic C. difficile strains.
Performance Comparison, Clinical Tests:
Study Type: Clinical trial comparing ImmunoCard C. difficile GDH to bacterial C. difficile culture.
Sample Size: 975 qualified patient samples.
Key Results: Overall sensitivity was 97.6% (95% Cl: 93.3 – 99.2%) and overall specificity was 87.0% (95% Cl: 84.6 – 90.1%). No differences in test performance were observed based on patient age, gender, or geographic location.
Reproducibility: Blinded coded panels were tested by three clinical laboratories. The overall correlation for the reproducibility study was 99.7% (98.1 – 99.9%). The correlation for moderate positive and negative specimens was 100.0% (98.2 – 100.0%), and for high negative specimens was 98.9% (94.0 – 99.8%).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity: 97.6% (95% Cl: 93.3 – 99.2%)
Specificity: 87.0% (95% Cl: 84.6 – 90.1%)
Correlation: 88.4% (86.2 - 90.3%)
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.
K053572: TECHLAB C. DIFF QUIK CHEK®
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.
Not Found
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).
Not Found
§ 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
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.
1
| Image: Meridian
Bioscience, Inc. logo | K112048: Request for Additional Information
Attachment 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 glutamate | |
| dehydrogenase | Clostridium difficile glutamate | |
| dehydrogenase | ||
| Screening, Diagnostic, or | ||
| Identification Test | Screening | Screening |
| Specimen Types | ||
| Human Stool Unpreserved | Yes | Yes |
| Reagents/Components | ImmunoCard C. difficile GDH Test Cards | |
| ImmunoCard C. difficile GDH Enzyme | ||
| Conjugate | ||
| ImmunoCard Wash Buffer I | ||
| ImmunoCard Substrate I | ||
| ImmunoCard C. difficile GDH Sample | ||
| Diluent/Negative Control | ||
| ImmunoCard C. difficile GDH Positive | ||
| Control | ||
| Plastic transfer pipettes | Membrane Devices | |
| Enzyme Conjugate | ||
| Wash Buffer | ||
| Substrate | ||
| Diluent | ||
| Positive Control | ||
| Disposable 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-solid | ||
| stool | 1. 25 µL of thoroughly mixed stool into 200 µL Sample Diluent. Vortex for 10 seconds. |
- Add 3 drops of Enzyme Conjugate to the sample.
- Incubate diluted sample at 20-26 C for 15 minutes. | 1. 1 drop of Enzyme Conjugate into 500 µL Diluent
- 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. - Add 3 drops of Enzyme Conjugate to the sample. | 1. Add 500 µL Diluent to a clean tube.
- Add 1 drop Conjugate to the Diluent tube.
- 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 | Vortex
Interval timer
Applicator sticks
Small test tubes
Disposable latex gloves | Pipettor and tips
Vortex
Interval timer
Applicator sticks
Small test tubes
Disposable latex gloves |
| Reading Method | Visual | Visual |
.
2
| Image: Meridian Bioscience, Inc. logo | K112048: Request for Additional Information
Attachment 009: Revised 510(k) Summary | | |
|---------------------------------------|---------------------------------------------------------------------------------------|-----------------------------|---------------------------|
| | Product Information: | ImmunoCard C. difficile GDH | |
| | Date: | November 29, 2011 | Document
Revision: 002 |
Table 1: Comparison to predicate device contd.
| Results Interpretation | ||
|---|---|---|
| Visual Read | Negative: Blue color in the CONTROL | |
| reaction port only. | ||
| Positive: Blue color in the TEST and | ||
| CONTROL reaction ports. | ||
| Invalid: No detectable blue color in the | ||
| CONTROL reaction port or a blue ring on | ||
| the plastic frame surrounding the TEST port | ||
| during the test procedure. | Negative: Single blue line visible on the | |
| CONTROL side of the reaction window only. | ||
| Positive: Blue line visible on the TEST side | ||
| along with a blue line visible on the | ||
| CONTROL side. | ||
| Invalid: Single line visible on the TEST side of | ||
| the reaction window or no lines visible in the | ||
| reaction 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
3
| Meridian
Bioscience, Inc. | K112048: Request for Additional Information
Attachment 009: Revised 510(k) Summary | | |
|------------------------------|---------------------------------------------------------------------------------------|-----------------------|-----|
| | Product Information: ImmunoCard C. difficile GDH | | |
| Date: | November 29, 2011 | Document
Revision: | 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.
4
| Meridian
Bioscience, Inc. | K112048: Request for Additional Information
Attachment 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 Trial
Site | ImmunoCard
C. difficile
GDH/Culture | % Sensitivity | 95% CI | ImmunoCard
C. difficile
GDH/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 | ImmunoCard
C. difficile
GDH/Culture | Sensitivity % | 95% Cl | ImmunoCard
C. difficile
GDH/Culture | Specificity % | 95% Cl |
|--------------|-------------------------------------------|---------------|---------------|-------------------------------------------|---------------|---------------|
| 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
9
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
10
Page 2 – Susan Bogar
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
11
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