(210 days)
SHIGA TOXIN QUIK CHEK; K121364
No
The summary describes a qualitative fluorescent immunoassay read by an analyzer, with no mention of AI/ML terms or methodologies.
No
The device is an in vitro diagnostic test designed to detect and differentiate Shiga toxins, aiding in the diagnosis of infections. It does not provide treatment or directly apply therapy to a patient.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "intended for use with cultures derived from human stool specimens to aid in the diagnosis of disease caused by Shiga toxin producing Escherichia coli (STEC) infections." Additionally, the "Device Description" identifies it as a "qualitative in vitro diagnostic test."
No
The device description explicitly states it is an "in vitro diagnostic test" that "utilizes fluorescence technology with the cleared Curian® Analyzer (K192817)". This indicates it is a physical assay kit used in conjunction with a hardware analyzer, not 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 "a rapid, qualitative, fluorescent immunoassay for the simultaneous detection and differentiation of Shiga toxin 1 (Stx1) and Shiga toxin 2 (Stx2)... It is intended for use with cultures derived from human stool specimens to aid in the diagnosis of disease caused by Shiga toxin producing Escherichia coli (STEC) infections." This clearly indicates its use in examining specimens from the human body to provide information for diagnosis.
- Device Description: The description further clarifies that it is "a qualitative in vitro diagnostic test for the detection of Shiga toxin 1 (Stx1) and Shiga toxin 2 (Stx2) in cultures derived from human stool specimens." The term "in vitro diagnostic test" is a direct confirmation.
- Anatomical Site: It specifies the use of "human stool specimens," which are samples taken from the human body.
- Intended User / Care Setting: It is for "prescription use only," indicating it is used in a healthcare setting under the direction of a medical professional for diagnostic purposes.
All these points align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Curian Shiga Toxin assay, for use with the Curian Analyzer, is a rapid, qualitative, fluorescent immunoassay for the simultaneous detection and differentiation of Shiga toxin 1 (Stx1) and Shiga toxin 2 (Stx2) in a single test device. It is intended for use with cultures derived from human stool specimens to aid in the diagnosis of disease caused by Shiga toxin producing Escherichia coli (STEC) infections. Test results are to be used in conjunction with the patient's clinical symptoms and history.
Product codes (comma separated list FDA assigned to the subject device)
GMZ
Device Description
The Curian® Shiga Toxin assay is a qualitative in vitro diagnostic test for the detection of Shiga toxin 1 (Stx1) and Shiga toxin 2 (Stx2) in cultures derived from human stool specimens. The Curian® Shiga Toxin assay utilizes fluorescence technology with the cleared Curian® Analyzer (K192817) to detect Stx1 and Stx2 in cultures derived from human stool.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
human stool specimens
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Prospective Clinical Study:
- Sample Size: 1,627 stool specimens, with 1,538 evaluable prospective specimens.
- Data Source: Five clinical study sites representing geographically distinct regions throughout the United States. Specimens were collected from September 2021 to June 2022 from patients suspected of having STEC infection for whom a diagnostic E. coli test had been ordered.
- Annotation Protocol: All specimens were tested at the study sites with the Curian Shiga Toxin assay using stool specimens inoculated into appropriate broth. Concurrently, all specimens were tested in a central laboratory with the reference method, the Vero cell Cytotoxin Assay (with neutralization) performed on the broth culture obtained from the stool specimen.
Archived Clinical Study:
- Sample Size: 140 archived stool samples, with 135 evaluable archived specimens (5 excluded due to inconclusive Vero cell Cytotoxin results).
- Data Source: Archived stool samples.
- Annotation Protocol: Retrospectively tested for Stx1 and Stx2 using the Curian Shiga Toxin assay at all five study sites (same reference method as prospective study, Vero cell Cytotoxin Assay).
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
1. Analytical Performance
-
Precision/Reproducibility:
- Study Type: Reproducibility study across three independent laboratories.
- Sample Size: 900 blinded samples (10 panels of 30 samples, tested at 3 labs).
- Key Results:
- For Stx1, overall agreement with expected assay result was 99.6% (95% Cl: 98.9% - 99.8%). Agreement for combined Stx1 and Stx2 high negative samples was 95.6% (95% Cl: 89.1% - 98.3%).
- For Stx2, overall agreement with expected assay result was 99.7% (95% C1: 99.0% - 99.9%). Agreement for Stx2 high negative samples was 97.8% (95% -99.4%), and for combined Stx1 and Stx2 high negative samples was 98.9% (95% Cl: 94.0% - 99.8%).
-
Analytical Sensitivity (LoD):
- Study Type: Limit of detection study.
- Key Results: LoD for Stx1 is 0.185 ng/mL and for Stx2 is 0.125 ng/mL.
-
Prozone / Hook Effect:
- Study Type: Evaluation of high dose prozone/hook effect.
- Sample Size: 15 total dilutions (7 for Stx1, 7 for Stx2, 1 combined).
- Key Results: A prozone/hook effect was not observed.
-
Cross-Reactivity/Microbial Interference:
- Study Type: Cross-reactivity and microbial interference study.
- Key Results: No cross-reactivity or microbial interference was observed except for S. dysenteriae (strain ATCC 9361), which was found to be Stx1 positive at concentrations greater than 1.25 x 10^6 CFU/mL.
-
Interfering Substances:
- Study Type: Interference testing.
- Key Results: Interference was not observed for any of the substances evaluated.
-
Assay Reactivity/Inclusivity:
- Key Results: All tested STEC strains representing various serotypes and toxin combinations showed reactivity.
2. Clinical Performance
-
Prospective Clinical Study:
- Study Type: Clinical sensitivity and specificity against Vero cell Cytotoxin Assay.
- Sample Size: 1,538 evaluable prospective specimens.
- Key Results:
- Stx1: Sensitivity 100.0% [56.6% - 100.0%], Specificity 99.4% [98.9% - 99.7%].
- Stx2: Sensitivity 100.0% [51.0% - 100.0%], Specificity 99.5% [99.1% - 99.8%].
- No observable differences in performance with respect to study site, broth type, kit lot, or patient gender or age.
-
Archived Clinical Study:
- Study Type: Clinical sensitivity and specificity against Vero cell Cytotoxin Assay.
- Sample Size: 135 evaluable archived specimens.
- Key Results:
- Stx1: Sensitivity 100.0% [92.3% - 100.0%], Specificity 97.8% [92.2% - 99.4%].
- Stx2: Sensitivity 97.0% [84.7% - 99.5%], Specificity 98.0% [93.1% - 99.5%].
- No observable differences in performance with respect to study site, broth type, kit lot, or patient gender or age.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Prospective Clinical Study:
- Stx1:
- Sensitivity: 100.0% [56.6% - 100.0%]
- Specificity: 99.4% [98.9% - 99.7%]
- Stx2:
- Sensitivity: 100.0% [51.0% - 100.0%]
- Specificity: 99.5% [99.1% - 99.8%]
Archived Clinical Study:
- Stx1:
- Sensitivity: 100.0% [92.3% - 100.0%]
- Specificity: 97.8% [92.2% - 99.4%]
- Stx2:
- Sensitivity: 97.0% [84.7% - 99.5%]
- Specificity: 98.0% [93.1% - 99.5%]
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.
SHIGA TOXIN QUIK CHEK; K121364
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
§ 866.3255
Escherichia coli serological reagents.(a)
Identification. Escherichia coli serological reagents are devices that consist of antigens and antisera used in serological tests to identifyEscherichia coli from cultured isolates derived from clinical specimens. Additionally, some of these reagents consist ofEscherichia coli antisera conjugated with a fluorescent dye used to identifyEscherichia coli directly from clinical specimens or cultured isolates derived from clinical specimens. The identification aids in the diagnosis of diseases caused by this bacterium belonging to the genusEscherichia, and provides epidemiological information on diseases caused by this microorganism. AlthoughEscherichia coli constitutes the greater part of the microorganisms found in the intestinal tract in humans and is usually nonpathogenic, those strains which are pathogenic may cause urinary tract infections or epidemic diarrheal disease, especially in children.(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 the limitations in § 866.9.
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April 17, 2023
Meridian Bioscience Inc. Heather Planck Regulatory Affairs Specialist 3471 River Hills Drive Cincinnati, Ohio 45244
Re: K222829
Trade/Device Name: Curian® Shiga Toxin Regulation Number: 21 CFR 866.3255 Regulation Name: Escherichia Coli Serological Reagents Regulatory Class: Class I Product Code: GMZ Dated: September 19, 2022 Received: September 19, 2022
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 -S
Ribhi Shawar, Ph.D. Chief General Bacteriology and Antimicrobial Susceptibility Branch Division of Microbiology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K222829
Device Name Curian Shiga Toxin
Indications for Use (Describe)
The Curian Shiga Toxin assay, for use with the Curian Analyzer, is a rapid, qualitative, fluorescent immunoassay for the simultaneous detection and differentiation of Shiga toxin 2 (Stx2) in a single test device. It is intended for use with cultures derived from human stool specimens to aid in the diagnosis of disease caused by Shiga toxin producing Escherichia coli (STEC) infections. Test results are to be used in conjunction with the patient's clinical symptoms and history.
| 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) Summary
510(k) number: K222829
Date of Preparation: April 17, 2023
A. 510(k) Number:
B. Purpose for Submission:
To determine substantial equivalence for the Curian® Shiga Toxin assay used to detect Shiga toxin 1 (Stx1) and Shiga toxin 2 (Stx2) in cultures derived from stool samples.
C. Measurand:
Shiga toxin 1 (Stx1) and Shiqa toxin 2 (Stx2)
D. Type of Test:
Lateral flow fluorescent immunoassay
E. Applicant:
Meridian Bioscience, Inc.
F. Proprietary and Established Names:
Curian® Shiga Toxin
G. Regulatory Information:
| Product Code | Classification | Regulation Section | Panel |
|---|---|---|---|
| GMZ | I | 21 CFR 866.3255 – Escherichia coli | |
| serological reagents | MI – Microbiology (83) |
H. Intended Use:
-
- Intended Use:
The Curian Shiga Toxin assay, for use with the Curian Analyzer, is a rapid, qualitative, fluorescent immunoassay for the simultaneous detection and differentiation of Shiga toxin 1 (Stx1) and Shiga toxin 2 (Stx2) in a single test device. It is intended for use with cultures derived from human stool specimens to aid in the diagnosis of disease caused by Shiga toxin producing Escherichia coli (STEC) infections. Test results are to be used in conjunction with the patient's clinical symptoms and history.
- Intended Use:
-
- Indications for use:
Same as Intended Use.
- Indications for use:
-
Special Conditions for use Statement(s): റ്റ്
For prescription use only. -
- Special Instrument Requirements:
Curian Analyzer
- Special Instrument Requirements:
4
l. Device Description:
The Curian® Shiga Toxin assay is a qualitative in vitro diagnostic test for the detection of Shiga toxin 1 (Stx1) and Shiga toxin 2 (Stx2) in cultures derived from human stool specimens. The Curian® Shiga Toxin assay utilizes fluorescence technology with the cleared Curian® Analyzer (K192817) to detect Stx1 and Stx2 in cultures derived from human stool.
Reagents and Test Components:
The Curian® Shiga Toxin assay kit contains the following components:
- Curian® Shiga Toxin Test Card: A test strip enclosed in a plastic frame which is in a foil pouch with . a desiccant. The desiccant is pink; if the packaging is compromised, the desiccant will be blue. Supplied ready to use.
- . Curian® Shiga Toxin Aioprep™ Sample Preparation Device/ Negative Control: A buffered aqueous protein solution containing blue dye and 0.094% sodium azide. The Aioprep™ device is fitted with a dropper tip. Supplied ready to use.
- . Curian® Shiga Toxin Positive Control: Inactivated Shiga toxins 1 and 2 in an aqueous phosphate buffered solution containing 0.094% sodium azide. Supplied ready to use.
- . Pipette I: Transfer pipettes graduated to 50 µL and 175 µL.
- Pipette II: Transfer pipettes graduated up to 1.0 mL. .
J. Substantial Equivalence Information:
-
- Predicate device name(s): SHIGA TOXIN QUIK CHEK
-
- Predicate 510(k) number: K121364
-
- Comparison with predicate:
| | NEW DEVICE
Curian® Shiga Toxin | PREDICATE DEVICE
SHIGA TOXIN QUIK CHEK
K121364 |
|--------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Similarities | |
| Intended Use/
Indications for Use | The Curian Shiga Toxin assay, for use with
the Curian Analyzer, is a rapid, qualitative,
fluorescent immunoassay for the
simultaneous detection and differentiation of
Shiga toxin 1 (Stx1) and Shiga toxin 2 (Stx2)
in a single test device. It is intended for use
with cultures derived from human stool
specimens to aid in the diagnosis of disease
caused by Shiga toxin producing
Escherichia coli (STEC) infections. Test
results are to be used in conjunction with the
patient's clinical symptoms and history. | The SHIGA TOXIN QUIK CHEK test is a
rapid membrane enzyme immunoassay for
the simultaneous qualitative detection and
differentiation of Shiga toxin 1 (Stx1) and
Shiga toxin 2 (Stx2) in a single test device.
It is intended for use with human fecal
samples from patients with gastrointestinal
symptoms to aid in the diagnosis of
disease caused by Shiga toxin producing
Escherichia coli (STEC). It may be used
with fecal specimens, or broth or plate
cultures derived from fecal specimens. The
test results should be considered in
conjunction with the patient history. |
| Classification | Class I | Same |
| Product Code | GMZ | Same |
| Regulation | 21 CFR 866.3255 | Same |
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| | NEW DEVICE
Curian® Shiga Toxin | PREDICATE DEVICE
SHIGA TOXIN QUIK CHEK
K121364 |
|------------------------------|-----------------------------------------------------------------------------------------------------|------------------------------------------------------|
| Measured Analyte | Shiga toxin 1 (Stx1) and Shiga toxin 2 (Stx2) | Same |
| Antibody Format | Monoclonal/Polyclonal | Same |
| Target Population | Persons suspected of having disease
caused by Shiga toxin producing E. coli
(STEC) infections | Same |
| Type of Test | Qualitative | Same |
| Specimen Type | Human Stool Specimen | Same |
| Sample Matrix | Broth and Plate Cultures Derived from
Human Stool Specimens | Same |
| Controls | Positive and negative control included in the
kit. Internal Control line. | Same |
| Read Result Time |