(266 days)
No
The document describes a qualitative fluorescent immunoassay read by an analyzer, with no mention of AI or ML in the device description, intended use, or performance studies.
No.
This device is an in vitro diagnostic test intended to aid in the diagnosis of Campylobacter infection by detecting specific antigens, not to provide therapy or treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states, "Curian Campy is intended to aid in the diagnosis of Campylobacter infection." Additionally, the "Device Description" identifies it as a "qualitative in vitro diagnostic test."
No
The device description explicitly states that the Curian® Campy assay utilizes fluorescence technology with the cleared Curian® Analyzer (K192817) to detect antigens. This indicates the device relies on a hardware component (the analyzer) for its function, making it a combination product (assay + analyzer) rather than a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The description explicitly states it is "for the detection of a Campylobacter-specific antigen in human fecal specimens" and "intended to aid in the diagnosis of Campylobacter infection." This clearly indicates it is used to test samples taken from the human body to provide information for diagnostic purposes.
- Device Description: The description explicitly states it is a "qualitative in vitro diagnostic test for the detection of Campylobacter-specific antigens in human stool samples." The term "in vitro diagnostic" is used directly.
- Anatomical Site: It uses "human fecal specimens (stool)," which are samples taken from the human body.
- Performance Studies: The studies described involve testing human samples (prospective and archived studies) and contrived samples to evaluate the device's performance in detecting the target analyte.
- Predicate Device: A predicate device (K191456; CAMPYLOBACTER QUIK CHEK) is listed, which is common for IVD submissions to the FDA.
- Reference Device: A reference device (K192817; Curian® Analyzer) is listed, indicating it is part of a system used for in vitro testing.
All these points align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Curian Campy, for use with the Curian Analyzer, is a rapid, qualitative fluorescent immunoassay for the detection of a Campylobacter-specific antigen in human fecal specimens. Curian Campy is intended to detect C. jejuni, C. coli, C. upsaliensis, and C. lari in human stool from patients with signs and symptoms of gastroenteritis. The test is intended for use with unpreserved fecal specimens or preserved fecal specimens in transport media. Test results are to be used in conjunction with information available from the patient clinical evaluation and other diagnostic procedures. Curian Campy is intended to aid in the diagnosis of Campylobacter infection.
Product codes (comma separated list FDA assigned to the subject device)
LQP
Device Description
The Curian® Campy assay is a qualitative in vitro diagnostic test for the detection of Campylobacter-specific antigens in human stool samples collected from individuals with signs and symptoms of gastroently. Curian Campy is intended to detect C. jejuni, C. coli, C. upsaliensis, and C. lari in unpreserved or preserved stool in Cary-Blair or C&S transport media. The Curian® Campy assay utilizes fluorescence technology with the cleared Curian® Analyzer (K192817) to detect Campylobacter-specific antigens in human stool.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
human fecal specimens / human stool
Indicated Patient Age Range
Not Found
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Performance Data:
- Precision/Reproducibility: Testing contrived samples (high negative, low positive, moderate positive, and true negative) across three sites (one internal, two external) over 5 nonconsecutive days with 2 operators per day and three different kit lots. Total of 320 samples (n=160 unpreserved stool and n=160 preserved stools in C&S media). Results were consistent, with 100% PA for true negative (preserved and unpreserved) and moderate positive (unpreserved). High negative unpreserved stool showed 98.7% PA, preserved stool showed 95.3% PA. Low positive unpreserved stool showed 82.7% PA (lower than expected due to under-sampling), and low positive preserved stool showed 100% PA.
- Analytical Sensitivity (LoD): Determined the LoD for C. jejuni, C. coli, C. upsaliensis, and C. lari in unpreserved, C&S preserved, and Cary-Blair preserved human stool matrix using three lots of the assay.
- C. jejuni: Unpreserved Stool LoD: 4.00x10^5 CFU/mL (1818 CFU/test); C&S Preserved LoD: 7.25x10^5 CFU/mL (2266 CFU/test); Cary-Blair Preserved LoD: 7.25x10^5 CFU/mL (2266 CFU/test).
- C. coli: Unpreserved Stool LoD: 3.00x10^6 CFU/mL (13636 CFU/test); C&S Preserved LoD: 1.57x10^7 CFU/mL (49063 CFU/test); Cary-Blair Preserved LoD: 1.57x10^7 CFU/mL (49063 CFU/test).
- C. upsaliensis: Unpreserved Stool LoD: 1.62x10^6 CFU/mL (7386 CFU/test); C&S Preserved LoD: 1.18x10^6 CFU/mL (3681 CFU/test); Cary-Blair Preserved LoD: 2.36x10^6 CFU/mL (7375 CFU/test).
- C. lari: Unpreserved Stool LoD: 5.00x10^6 CFU/mL (22727 CFU/test); C&S Preserved LoD: 1.16x10^7 CFU/mL (36250 CFU/test); Cary-Blair Preserved LoD: 1.16x10^7 CFU/mL (36250 CFU/test).
- Prozone / Hook Effect: Tested dilutions of C. jejuni whole cell stock in negative sample matrix (ranging from 2.70x10^6 to 1.73x10^8 CFU/mL for preserved and 2.70x10^8 CFU/mL for unpreserved). 7 dilutions for both preserved and unpreserved (n=14 total), 5 replicates each. No prozone/hook effect observed.
- Cross-Reactivity/Microbial Interference: Evaluated bacteria, fungi, and viral strains spiked into unpreserved stool in C&S media, both in the absence and presence of C. jejuni (at 2x LoD). No cross-reactivity or microbial interference observed except for C. helveticus (strain ATCC 51209), which was positive at concentrations > 3.75x10^6 CFU/mL in unpreserved stool and > 7.50x10^6 CFU/mL in preserved stool matrix.
- Interfering Substances: Tested various chemical and biological substances (e.g., Barium Sulfate, Human blood, Mylanta, etc.) introduced into contrived C. jejuni low positive unpreserved and preserved stool samples. No interference observed.
- Assay Reactivity/Inclusivity: Evaluated several strains of C. jejuni, C. coli, C. upsaliensis, and C. lari with unpreserved and C&S preserved stool. All tested strains generated positive results.
- Brush Bridging Study: Evaluated 53 non-pipettable stool specimens (5 positive, 48 negative) using the Curian Campy Stool Collection Brush from prospective and archived clinical studies. An analytical bridging study with contrived positive (n=25 at 3x LoD, n=25 at 5x LoD) and negative (n=25) non-pipettable stool samples. All positive samples gave expected positive results, and all negative samples were negative, indicating effective collection with the brush.
Clinical Performance Data:
- Prospective Study: Sample size: 1,474 specimens from patients with gastroenteritis. Tested at five clinical sites (July 2020 - December 2020). Compared against culture and speciation as reference method.
- Sensitivity: 85.7% (95% CI: [65.4% - 95.0%])
- Specificity: 98.1% (95% CI: [97.2% - 98.7%])
- Discordant results investigated with FDA-cleared NAAT.
- Archived Study: Sample size: 290 archived samples with culture and speciation results. Retrospectively tested at five study sites.
- Sensitivity: 96.6% (95% CI: [82.8% - 99.4%])
- Specificity: 98.1% (95% CI: [95.6% - 99.2%])
- Contrived Study: Sample size: 210 contrived samples (n=150 positive, n=60 negative) at 2xLoD and 8xLoD for C. coli, C. upsaliensis, and C. lari, using 3 reagent lots. Represented both unpreserved (n=105) and C&S preserved (n=105) stool.
- Positive Percent Agreement (PPA): 100.0% (95% CI: [97.5% - 100.0%])
- Negative Percent Agreement (NPA): 100.0% (95% CI: [94.0% - 100.0%])
- All 210 specimens tested as expected, yielding 100% correlation with anticipated results.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Prospective Study:
- Sensitivity: 85.7% (95% CI: [65.4% - 95.0%])
- Specificity: 98.1% (95% CI: [97.2% - 98.7%])
Archived Study:
- Sensitivity: 96.6% (95% CI: [82.8% - 99.4%])
- Specificity: 98.1% (95% CI: [95.6% - 99.2%])
Contrived Study:
- PPA: 100.0% (95% CI: [97.5% - 100.0%])
- NPA: 100.0% (95% CI: [94.0% - 100.0%])
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.
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.
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
§ 866.3110
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).
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 23, 2021
Meridian Bioscience, Inc. Heather Planck Regulatory Affairs Specialist 3471 River Hills Drive Cincinnati, Ohio 45244
Re: K210976
Trade/Device Name: Curian Campy Regulation Number: 21 CFR 866.3110 Regulation Name: Campylobacter fetus Serological Reagents Regulatory Class: Class I, reserved Product Code: LQP Dated: March 31, 2021 Received: April 1, 2021
Dear Heather Planck:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part
1
801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Ribhi Shawar, Ph.D. (ABMM) Chief General Bacteriology and Antimicrobial Susceptibility Branch Division of Microbiology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name
Indications for Use (Describe)
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) number: K210976
Date of Preparation: December 22, 2021
| Owner: | Meridian Bioscience, Inc.
3471 River Hills Drive
Cincinnati, Ohio 45244 USA
Phone: (513) 271-3700
Fax: (513) 272-5213 |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Primary Contact:
Heather Planck
Regulatory Affairs Specialist |
| Trade Name: | Curian® Campy |
| Common Name: | Campylobacter Spp. |
| Classification Name: | Campylobacter fetus serological reagents
(21 CFR 866.3110, Product Code LQP) |
Device Description
The Curian® Campy assay is a qualitative in vitro diagnostic test for the detection of Campylobacter-specific antigens in human stool samples collected from individuals with signs and symptoms of gastroently. Curian Campy is intended to detect C. jejuni, C. coli, C. upsaliensis, and C. lari in unpreserved or preserved stool in Cary-Blair or C&S transport media. The Curian® Campy assay utilizes fluorescence technology with the cleared Curian® Analyzer (K192817) to detect Campylobacter-specific antigens in human stool.
Intended Use / Indications for Use
Curian Campy, for use with the Curian Analyzer, is a rapid, qualitative fluorescent immunoassay for the detection of a Campylobacter-specific antigen in human fecal specimens. Curian Campy is intended to detect C. jejuni, C. coli, C. upsaliensis, and C. lari in human stool from patients with signs and symptoms of gastroenteritis. The test is intended for use with unpreserved fecal specimens or preserved fecal specimens in transport media. Test results are to be used in conjunction with information available from the patient clinical evaluation and other diagnostic procedures. Curian Campy is intended to aid in the diagnosis of Campylobacter infection.
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Predicate Device Comparison
| Similarities Between the New Device and the Predicate Device | ||
|---|---|---|
| NEW DEVICE | ||
| CurianTM Campy | PREDICATE DEVICE | |
| CAMPYLOBACTER QUIK CHEK | ||
| K191456 | ||
| Intended Use/ | ||
| Indications for Use | Curian Campy, for use with the Curian | |
| Analyzer, is a rapid, qualitative fluorescent | ||
| immunoassay for the detection of a | ||
| Campylobacter-specific antigen in human | ||
| fecal specimens. Curian Campy is intended | ||
| to detect C. jejuni, C. coli, C. upsaliensis, | ||
| and C. lari in human stool from patients with | ||
| signs and symptoms of gastroenteritis. The | ||
| test is intended for use with unpreserved | ||
| fecal specimens or preserved fecal | ||
| specimens in transport media. Test results | ||
| are to be used in conjunction with | ||
| information available from the patient clinical | ||
| evaluation and other diagnostic procedures. | ||
| Curian Campy is intended to aid in the | ||
| diagnosis of Campylobacter infection. | The CAMPYLOBACTER QUIK CHEK test | |
| is a rapid membrane enzyme-linked | ||
| immunosorbent assay for the qualitative | ||
| detection of a Campylobacter -specific | ||
| antigen in human fecal specimens. The | ||
| CAMPYLOBACTER QUIK CHEK test is | ||
| designed to detect C. jejuni, C. coli, C. lari , | ||
| and C. upsaliensis from patients with signs | ||
| and symptoms of gastroenteritis. The test | ||
| is intended for use with preserved fecal | ||
| specimens in transport media and | ||
| unpreserved fecal specimens. Test results | ||
| should be considered in conjunction with | ||
| clinical findings and patient history. | ||
| Classification | Class I | Same |
| Product Code | LQP | Same |
| Regulation | 21 CFR 866.3110 | Same |
| Measured Analyte | Campylobacter -specific antigen | Same |
| Antibody Format | Monoclonal/Polyclonal | Same |
| Target Population | Individuals with signs and symptoms of | |
| gastroenteritis | Same | |
| Type of Test | Qualitative | Same |
| Sample Matrix | Human fecal specimen | Same |
| Specimen Type | Unpreserved fecal specimens and fecal | |
| specimens in Cary-Blair and C&S Transport | ||
| Media | Same | |
| Controls | Positive and negative control included in the | |
| kit. Internal Control line | Same | |
| Species Detected | C. jejuni, C. coli, C. lari, and C. upsaliensis | Same |
| Read Result Time | C. upsaliensis | 2016/1950 |
| ATCC 43953 | 2x | |
| 2016/2697 | 56x | |
| 2018/0319H | 40x | |
| ATCC 700558 | 24x | |
| C. lari | 2013/0823H | 8x |
| 2015/0814 | 8x | |
| 2016/0235 | 8x | |
| ATCC 35222 | 8x | |
| ATCC 35223 | 24x |
Brush Bridging Study
The Curian Campy assay is for use with unpreserved human stool specimens and human stool specimens preserved in Cary-Blair and C&S transport media. Most specimens are easily sampled using the transfer pipette provided in the kit; however, some unpreserved stool specimens are non-pipettable and require use of a specific brush (i.e., Curian Campy Stool Collection Brush, sold separately by Meridian) to adequately collect the sample for analysis in the Curian Campy assay. Fifty-three non-pipettable stool specimens (5 Campylobacter positives and 48 negatives) were processed with the brush during the prospective and archived clinical studies, combined.
To further support use of the brush with the Curian Campy assay, an analytical bridging study was performed that evaluated a panel consisting of contrived positive and negative samples collected/processed with the brush. Contrived positive samples were generated by spiking C. jejuni (strain ATCC #BAA-1234) into negative, non-pipettable stool samples were prepared at 3x LoD and 25 samples were prepared at 5x LoD. Twenty-five negative samples were also tested. Three non-expert operators tested each sample at one internal site. All positive samples gave the expected positive results, and all negative samples were negative. These results indicate that non-pipettable stool specimens can be collected with the brush prior to testing with the Curian Campy assay.
CLINICAL PERFORMANCE DATA
Clinical Performance
Prospective Study
The Curian Campy assay was evaluated from July 2020 to December 2020 at five clinical study sites representing geographically distinct regions throughout the United States. There were 1,474 specimens from patients with signs and symptoms of gastroenteritis for whom a diagnostic Campylobacter test had been ordered by a practicing physician, prospectively collected and enrolled into the study. All specimens were tested at the study sites with the Curian Campy assay and either had current standard of care Campylobacter culture and speciation performed and results available (reference method) or culture and speciation was performed as part of the study. The vast majority of specimens were pipettable and were processed with the Curian Campy pipette included in the kit. A small subset of specimens were nonpipettable and were processed with the Curian Campy Collection Brush (sold separately by Meridian). Clinical performance (sensitivity and specificity) for prospective specimens against the reference method (culture and speciation) are presented in the following table. There were no observable differences in
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performance of the Curian Campy assay with respect to study site, storage condition, kit lot, or patient gender or age. Prospective specimens with discordant results between the Curian Campy assay and the reference method were further evaluated of care (SoC) results obtained with an FDAcleared commercial nucleic acid amplification test (NAAT); results of discordant testing are footnoted below.
| | | Reference Method: Culture and
Speciation | | | | | |
|-----------------------|----------|---------------------------------------------|----------|-------|-------------|----------|-----------------|
| | | Positive | Negative | Total | Parameter | Estimate | 95% CI |
| | Positive | 18 | 28** | 46 | Sensitivity | 85.7% | [65.4% - 95.0%] |
| Curian Campy
Assay | Negative | 3* | 1425 | 1428 | Specificity | 98.1% | [97.2% - 98.7%] |
| | Total | 21 | 1453 | 1474 | | | |
| Curian Campy Overall Performance for Prospective Specimens versus Culture and Speciation | ||
|---|---|---|
- The Standard of Care (SoC) testing of two of the three false negative specimens by a high sensitivity, FDA-cleared nucleic acid amplification (NAAT) assay showed that one of the specimens produced a negative Campylobacter result, whereas one of the specimens produced a positive Campylobacter result; the third specimen was not subjected to NAAT testing as part of the SoC.
** Of the 28 false positive specimens, 10 were subjected to SoC testing by a high sensitivity, FDA-cleared NAAT assay. Two of these 10 specimens produced a positive Campylobacter result, whereas eight produced a negative Campylobacter result. Eighteen specimens were not subjected to NAAT testing as part of the SoC.
Archived Study
To further estimate sensitivity of the Curian Campy assay, 290 archived samples with culture and speciation results were retrospectively tested for Campylobacter antigen using the Curian Campy assay at all five study sites. The clinical performance (sensitivity and specificity) for archived samples against the reference method (culture and speciation) are presented in the table below.
| | | Reference Method: Culture and
Speciation | | | | | |
|-----------------------|----------|---------------------------------------------|----------|-------|-------------|----------|-----------------|
| | | Positive | Negative | Total | Parameter | Estimate | 95% CI |
| Curian Campy
Assay | Positive | 28 | 5 | 33 | Sensitivity | 96.6% | [82.8% - 99.4%] |
| | Negative | 1 | 256 | 257 | Specificity | 98.1% | [95.6% - 99.2%] |
| | Total | 29 | 261 | 290 | | | |
Curian Campy Overall Performance for Archived Samples versus Culture and Speciation
Contrived Study
Additional testing at each site was conducted with contrived samples at 2xLoD and 8xLoD for C. coli, C. upsaliensis, and C. lari and 3 reagent lots. All 210 specimens tested as expected with n=150 positive Campylobacter spp. specimen and n=60 negative specimen yielding 100% correlation with the anticipated results. Both sample matrices were represented with n=105 unpreserved stool specimens and n=105 stool specimens preserved in C&S transport media. The overall performance of the Curian Campy assay compared to the anticipated results is presented in the table below.
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Curian Campy Overall Performance for Contrived Specimens versus Contrived Anticipated Results
| Contrived: Anticipated Result | |||||||
|---|---|---|---|---|---|---|---|
| Positive | Negative | Total | Parameter | Estimate | 95% CI | ||
| Curian Campy | |||||||
| Assay | Positive | 150 | 0 | 150 | PPA | 100.0% | [97.5% - 100.0%] |
| Negative | 0 | 60 | 60 | NPA | 100.0% | [94.0% - 100.0%] | |
| Total | 150 | 60 | 210 |
CONCLUSION
The Curian® Campy assay, as supported by the information submitted in this premarket submission, is substantially equivalent to the predicate device (CAMPYLOBACTER QUIK CHEK; K191456).