(23 days)
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No
The device description details a standard enzyme immunoassay (EIA) process, which relies on chemical reactions and color changes for detection, not AI/ML algorithms. There are no mentions of AI, ML, deep learning, or image processing in the summary.
No
This device is an in vitro diagnostic (IVD) immunoassay intended for laboratory use to aid in the diagnosis of C. difficile associated disease by detecting toxins in stool samples, not to treat or cure a disease.
Yes
The 'Intended Use / Indications for Use' section explicitly states that "Premier Toxins A&B is intended for use as an aid in diagnosis of C. difficile associated disease." This directly indicates its role as a diagnostic tool.
No
The device description clearly outlines a physical enzyme immunoassay kit with reagents, microwells, and a colorimetric reaction, indicating it is a hardware-based diagnostic test, 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 for the detection of Clostridium difficile toxin A and toxin B in stool from patients. Stool is a biological specimen taken from the human body.
- Purpose: The intended use also states that it is "intended for use as an aid in diagnosis of C. difficile associated disease." This indicates that the device is used to provide information about a patient's health status based on the analysis of a biological sample.
- Device Description: The description details an "enzyme immunoassay for the direct detection of Clostridium difficile toxin A and toxin B in stool samples." This further confirms that the device is designed to analyze a biological specimen.
These points align with the definition of an In Vitro Diagnostic device, which is a medical device intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or congenital abnormality, or to monitor therapeutic measures.
N/A
Intended Use / Indications for Use
Premier Toxins A&B is a qualitative enzyme immunoassay for the detection of Clostridium difficile toxin A and toxin B in stool from patients with antibiotic associated diarrhea. Premier Toxins A&B is intended for use as an aid in diagnosis of C. difficile associated disease.
Product codes
LLH
Device Description
Premier Toxins A&B is an enzyme immunoassay for the direct detection of Clostridium difficile toxin A and toxin B in stool samples. Breakaway microwells are coated with toxin specific monoclonal and polyclonal antibodies. Diluted patient specimens and HRP-conjugated anti-toxin A and B polyclonal antibodies are added to microwells. If either toxin is present in the diluted patient samples, HRP-conjugated toxin polyclonal antibodies (specific for both toxins) complexes are formed which remain in the microwells after washing. After a final washing step, a substrate / chromagen (urea peroxide and tetramethylbenzidine) is added to the wells. Any bound conjugate converts the substrate / chromagen to a blue color. Addition of acid (Stop Solution) converts the blue to a vellow color.
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
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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
The performance of Premier Toxins A&B was evaluated in a clinical study performed at two sites in the United States. The kit was compared to the cellular cytotoxicity assay .
Summary of Performance Studies
The performance of Premier Toxins A&B was evaluated in a clinical study performed at two sites in the United States. The kit was compared to the cellular cytotoxicity assay.
Site 1:
Pos vs Neg Cytotoxin Result: Pos: 55, Neg: 7
Neg vs Pos Cytotoxin Result: Pos: 3, Neg: 257
Site 2:
Pos vs Neg Cytotoxin Result: Pos: 35, Neg: 6
Neg vs Pos Cytotoxin Result: Pos: 2, Neg: 208
All Sites:
Pos vs Neg Cytotoxin Result: Pos: 90, Neg: 13
Neg vs Pos Cytotoxin Result: Pos: 5, Neg: 465
Reproducibility:
Souce of Variance:
Positive Control: Mean Absorbance 2.010, Within Run CV 4.1%, Between Run CV 7.0%
Negative Control: Mean Absorbance 0.013, Within Run CV 24.5%, Between Run CV 16.2%
High Positive: Mean Absorbance 2.250, Within Run CV 7.3%, Between Run CV 6.2%
Medium Positive: Mean Absorbance 1.146, Within Run CV 6.9%, Between Run CV 13.9%
Low Positive: Mean Absorbance 0.280, Within Run CV 15.9%, Between Run CV 14.6%
Negative: Mean Absorbance 0.009, Within Run CV 28.9%, Between Run CV 31.7%
Cross-Reactivity: The Premier Toxins A&B test did not cross-react with other known pathogenic bacteria and viruses. Positive reactions were noted with two strains of C. sordellii known to produce the HT and LT homologues to toxins A and B, respectively.
Key Metrics
Sensitivity: Site 1: 94.8% (95% CI: 85.6-98.9%), Site 2: 94.6% (95% CI: 81.8-99.3%), All Sites: 94.7% (95% CI: 88.1-98.3%)
Specificity: Site 1: 97.3% (95% CI: 94.6-98.9%), Site 2: 97.2% (95% CI: 94.0-99.0%), All Sites: 97.3% (95% CI: 95.4-98.5%)
Positive Predictive Value: Site 1: 88.7% (95% CI: 78.1-95.3%), Site 2: 85.4% (95% CI: 70.8-94.4%), All Sites: 87.4% (95% CI: 81.0-93.8%)
Negative Predictive Value: Site 1: 98.8% (95% CI: 96.7-99.8%), Site 2: 99.0% (95% CI: 96.6-99.9%), All Sites: 98.9% (95% CI: 97.5-99.7%)
Correlation: Site 1: 96.9% (95% CI: 94.4-98.5%), Site 2: 96.8% (95% CI: 93.8-98.6%), All Sites: 96.9% (95% CI: 95.1-98.1%)
Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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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.
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Special 510(k): Device Modification Premier Toxins A&B
Item II: 510(k) Summary
A. Contacts
Manufacturer: Meridian Diagnostics, Inc. 3471 River Hills Drive Cincinnati, OH 45244 Phone: 513-271-3700 FAX: 513-271-0744
| FDA Registration Number: | 1524213 |
|---|---|
| Site Contact Person: | Allen Nickol, PhD |
| Senior Director Clinical & Regulatory Affairs & QA | |
| Submission Contact Persons: | David H. Willis, PhD |
| Clinical & Regulatory Affairs | |
| Allen Nickol, PhD | |
| Senior Director Clinical & Regulatory Affairs & QA |
Date of Preparation B.
November 12, 1999
C. Name of Device and Classification
Name: Premier Toxins A&B Classification: "Reagents, Clostridium difficile toxin," Class I, LLH.
D. Legally Marketed Device
The predicate (previously cleared) device is the Premier Cytoclone A&B EIA, 510(k) number K911958. Concurrence date was 7/30/91.
E. Device Description
Premier Toxins A&B is an enzyme immunoassay for the direct detection of Clostridium difficile toxin A and toxin B in stool samples. Breakaway microwells are coated with toxin specific monoclonal and polyclonal antibodies. Diluted patient specimens and HRP-conjugated anti-toxin A and B polyclonal antibodies are added to microwells. If either toxin is present in the diluted patient samples, HRP-conjugated toxin polyclonal antibodies (specific for both toxins) complexes are formed which remain in the microwells after washing. After a final washing step, a substrate / chromagen (urea peroxide and tetramethylbenzidine) is added to the wells. Any bound conjugate converts the substrate / chromagen to a blue color. Addition of acid (Stop Solution) converts the blue to a vellow color.
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Intended Use Statement F.
Premier Toxins A&B is a qualitative enzyme immunoassay for the detection of Clostridium difficile toxin A and toxin B in stool from patients with antibiotic associated diarrhea. Premier Toxins A&B is intended for use as an aid in diagnosis of C. difficile associated disease.
Description of the Technology of the Modified Device Compared to G. Cleared Device
Both devices are microtiter well enzyme immunoassays that involve capture of C. difficile toxins A and B by antibody attached to microtiter wells. Detection is accomplished in both assays using HRP-conjugated antibody. In both assays color change is affected using urea peroxide and tetramethylbenzidine. The differences in protocol and materials do not reflect any fundamental change in technology.
The performance of Premier Toxins A&B was evaluated in a clinical study performed at two sites in the United States. The kit was compared to the cellular cytotoxicity assay .
| Premier
Toxins A&B Results | Cytotoxin Result:
Site 1 | | Cytotoxin Result:
Site 2 | | Cytotoxin Result:
All Sites | |
|-------------------------------|-----------------------------|------------|-----------------------------|------------|--------------------------------|------------|
| | Pos | Neg | Pos | Neg | Pos | Neg |
| Pos | 55 | 7 | 35 | 6 | 90 | 13 |
| Neg | 3 | 257 | 2 | 208 | 5 | 465 |
| Performance Statistic | Value | 95% CI | Value | 95% CI | Value | 95% CI |
| Sensitivity | 94.8% | 85.6-98.9% | 94.6% | 81.8-99.3% | 94.7% | 88.1-98.3% |
| Specificity | 97.3% | 94.6-98.9% | 97.2% | 94.0-99.0% | 97.3% | 95.4-98.5% |
| Positive Predictive Value | 88.7% | 78.1-95.3% | 85.4% | 70.8-94.4% | 87.4% | 81.0-93.8% |
| Negative Predictive Value | 98.8% | 96.7-99.8% | 99.0% | 96.6-99.9% | 98.9% | 97.5-99.7% |
| Correlation | 96.9% | 94.4-98.5% | 96.8% | 93.8-98.6% | 96.9% | 95.1-98.1% |
H. Reproducibility
| Souce of Variance | Positive
Control | Negative
Control | High
Positive | Medium
Positive | Low Positive | Negative |
|-------------------|---------------------|---------------------|------------------|--------------------|--------------|----------|
| Mean Absorbance | 2.010 | 0.013 | 2.250 | 1.146 | 0.280 | 0.009 |
| Within Run CV | 4.1% | 24.5% | 7.3% | 6.9% | 15.9% | 28.9% |
| Between Run CV | 7.0% | 16.2% | 6.2% | 13.9% | 14.6% | 31.7% |
I. Cross-Reactivity
The Premier Toxins A&B test did not cross-react with other known pathogenic bacteria and viruses. Positive reactions were noted with two strains of C. sordellii known to produce the HT and LT homologues to toxins A and B, respectively.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or a stylized human figure with outstretched arms.
DEC I 0 1999
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
David H. Willis, Ph.D. Manager, Clinical and Regulatory Affairs Meridian Diagnostics, Inc. 3471 River Hills Drive Cincinnati, Ohio 45244
K993914 Re: Trade Name: Premier Toxins A&B Regulatory Class: I Product Code: LLH Dated: November 16, 1999 Received: November 17, 1999
Dear Dr. Willis:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770)488-7655.
This letter will allow you to begin marketing your device as described in your 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 Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll free number (800) 638-2041 or at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"
Sincerely yours.
Steven Butman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Item III: Indications of Use Statement
1993914 510(k) Number (if known):
Device Name: Premier Toxins A&B
Indications For Use:
Premier Toxins A&B is a qualitative enzyme immunoassay for the detection of Clostridium difficile toxin A and toxin B in stool from patients with antibiotic associated diarrhea. Premier Toxins A&B is intended for use as an aid in diagnosis of C. difficile associated disease.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Woody Dubois
510(k) Number
Prescription Use
(Per 21 CFR 801.109)
ાર
Over-The-Counter Use (Optional Format 1-2-96)