(277 days)
ImmunoCard Helicobacter pylori
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No
The device description and performance summary describe a standard immunoassay kit with reagents and controls, and there is no mention of AI or ML in any section.
No
The device is an in vitro diagnostic (IVD) test used to detect antibodies to H. pylori to aid in diagnosis, not to treat or directly restore health.
Yes.
The device detects IgG to H. pylori to aid in the diagnosis of H. pylori infection.
No
The device description clearly lists physical components like test cards, reagents, controls, tubes, and pipets, indicating it is a hardware-based in vitro diagnostic device, not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the device is an "in vitro qualitative procedure for the detection of IgG to Helicobacter pylori in human serum, plasma and whole blood." The term "in vitro" is a key indicator of an IVD, meaning it is used to test samples outside of the living body.
- Purpose: The intended use also states that the test results are "intended to aid in the diagnosis of H. pylori infection." This aligns with the purpose of IVDs, which are used to provide information for the diagnosis, monitoring, or treatment of diseases or conditions.
- Sample Type: The device is designed to test human serum, plasma, and whole blood, which are biological samples commonly used in IVD testing.
- Device Description: The description details the components of an assay system used for laboratory testing, further supporting its classification as an IVD.
N/A
Intended Use / Indications for Use
The ImmunoCard H. pylori enzyme immunoassay (EIA) is an in vitro qualitative procedure for the detection of IgG to Helicobacter pylori in human serum, plasma and whole blood. Test results are intended to aid in the diagnosis of H. pylori ImmunoCard H. pylori may be performed by infection. clinical laboratories or in physician's offices.
Product codes
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Device Description
The ImmunoCard H. pylori assay system is a membrane based EIA for detecting IgG to H. pylori in human serum and plasma. Each kit contains the following components: H. pylori Test Cards (30), Enzyme Conjugate (5ml), Wash Buffer (15ml), Substrate Reagent (15ml), Positive Control (2ml), Negative Control (2ml), Whole Blood Sample Diluent (6.5ml), Heparinized Capillary Tubes (30), Transfer Pipets (30).
Serum and Plasma Assay: Two drops of serum or plasma are added to each of the two sample ports. The serum migrates into the sample wicks and up towards the reaction ports and beyond. After one minute, two drops of conjugate (mouse antibody to human IgG, conjugated with monoclonal alkaline phosphatase) are added to each of the two reaction ports.
Whole Blood Assay: Four drops of Whole Blood Sample Diluent, then two drops of whole blood are added to a specimen cup. Two drops of the diluted whole blood are added to each of the two sample ports. The blood migrates into the sample wicks and up towards the reaction ports and beyond. After three minutes, two drops of conjugate (mouse monoclonal antibody to human IgG, conjugated with alkaline phosphatase) are added to each of the two reaction ports.
Both Assays: After conjugate absorption, two drops of wash buffer are added to the reaction ports, followed by two drops of substrate (BCIP). Reaction ports are observed for the development of any blue color after five minutes. The development of blue color in the right hand port indicates a positive test result for IgG to H. pylori. A lack of blue color in the right hand port indicates a negative result. The left reaction port, containing immobilized human IgG, serves as a procedural control. Failure of the left hand port to develop a blue color indicates an invalid test.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
clinical laboratories or in physician's offices.
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Comparison with Predicate Devices: The comparison supports the Statement of Equivalence between the ImmunoCard H. pylori and ImmunoCard Helicobacter pylori Whole Blood Assay.
n = 108
Relative Agreement = 99.1 + 1.8% (107/108)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Relative Agreement = 99.1 + 1.8% (107/108)
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.
ImmunoCard Helicobacter pylori
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
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§ 866.3110
Campylobacter fetus serological reagents.(a)
Identification. Campylobacter fetus serological reagents are devices that consist of antisera conjugated with a fluorescent dye used to identifyCampylobacter fetus from clinical specimens or cultured isolates derived from clinical specimens. The identification aids in the diagnosis of diseases caused by this bacterium and provides epidemiological information on these diseases.Campylobacter fetus is a frequent cause of abortion in sheep and cattle and is sometimes responsible for endocarditis (inflammation of certain membranes of the heart) and enteritis (inflammation of the intestines) in humans.(b)
Classification. Class I (general controls).
0
Meridian Diagnostics, Inc. Cincinnati, OH 45244
APPENDIX A - 510(k) SUMMARY
Identification Information A.
- Submitter's Information: 1 .
- Submitter's Name and Address: ំ .
Meridian Diagnostics, Inc. 3471 River Hills Drive 45244 Cincinnati, OH
- 1-800-543-1980 Phone Number: ు .
- Contact Person: Allen D. Nickol, Ph.D. ਾ . Director Scientific and Regulatory Affairs
- Date Summary Prepared: March 19, 1996 ੋਂ .
- Name of Device: ImmunoCard H. pylori 2. Classification Name: Campylobacter pylori (LYR)
- Predicate Equivalent Device: ImmunoCard Helicobacter 3. pylori
- Description of Device: The ImmunoCard H. pylori assay 4 . system is a membrane based EIA for detecting IgG to H. pylori in human serum and plasma. Each kit contains the following components:
- H. pylori Test Cards (30) a.
- Enzyme Conjugate (5ml) b.
- Wash Buffer (15ml) c.
- Substrate Reagent (15ml) ದೆ .
- Positive Control (2ml) e.
- Neqative Control (2ml) ェ.
- Whole Blood Sample Diluent (6.5ml) টা ব্যাটি টে
- Heparinized Capillary Tubes (30) h .
- Transfer Pipets (30) ..
Fri
Serum and Plasma Assay
Two drops of serum or plasma are added to each of the two sample ports. The serum migrates into the sample wicks and up towards the reaction ports and beyond. After one minute, two drops of conjugate (mouse antibody to human IgG, conjugated with monoclonal alkaline phosphatase) are added to each of the two reaction ports.
1
Meridian Diagnostics, Inc. Cincinnati, OH 45244
510 (k) Notification ImmunoCard H. pylori
Whole Blood Assay
Four drops of Whole Blood Sample Diluent, then two drops of whole blood are added to a specimen cup. Two drops of the diluted whole blood are added to each of the two sample ports. The blood migrates into the sample wicks and up towards the reaction ports and After three minutes, two drops of conjugate bevond. (mouse monoclonal antibody to human IgG, conjugated with alkaline phosphatase) are added to each of the two reaction ports.
Both Assays
After conjugate absorption, two drops of wash buffer are added to the reaction ports, followed by two drops of substrate (BCIP). Reaction ports are observed for the development of any blue color after five minutes. The development of blue color in the right hand port indicates a positive test result for IgG to H. pylori. A lack of blue color in the right hand port indicates a negative result. The left reaction port, containing immobilized human IqG, serves as a procedural control. Failure of the left hand port to develop a blue color indicates an invalid test.
- pylori enzyme Intended Use: The ImmunoCard H. 5. immunoassay (EIA) is an in vitro qualitative procedure for the detection of IgG to Helicobacter pylori in human serum, plasma and whole blood. Test results are intended to aid in the diagnosis of H. pylori ImmunoCard H. pylori may be performed by infection. clinical laboratories or in physician's offices.
- The following 6。 Comparison with Predicate Devices: comparison of performance supports the Statement of Equivalence between the ImmunoCard H. pylori and ImmunoCard Helicobacter pylori Whole Blood Assay.
| ImmunoCard H. pylori | ||
|---|---|---|
| ImmunoCard H. pylori | ||
| Whole Blood | Positive | Negative |
| Positive | 30 | 0 |
| Negative | 1 | 77 |
n = 108
Relative Agreement = = 99.1 + 1.8% (107/108)
"95% confidence intervals.
165
2
Meridian Diagnostics, Inc. Cincinnati, OH 45244
,
510 (k) Notification ImmunoCard H. pylori
Additional Information/Nonclinical Test Results: A.
-
- Reproducibility :
- Intra-assay and Inter-assay reproducibility of a. the positive control, negative control, positive specimens and negative specimens was 100%.
2. Sample Storage:
IgG to H. pylori is stable in whole blood for at least three days when stored at 4°C.
166