(115 days)
Not Found
No
The device description details a standard enzyme immunoassay (EIA) process involving antibody binding, washing steps, and a chromogenic substrate, with results read visually or spectrophotometrically. There is no mention of AI, ML, or any computational analysis beyond basic spectrophotometry.
No.
The device is an in vitro diagnostic (IVD) test for detecting C. difficile Toxin A and B to aid in diagnosis, not to treat a condition.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states, "The test is intended for use as an aid in diagnosis of Clostridium difficile-associated disease (CDAD)."
No
The device description clearly outlines a physical kit with microwell strips, antibodies, reagents, and a chromagenic substrate, indicating a hardware-based in vitro diagnostic test, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section explicitly states: "For In vitro Diagnostic Use."
- Nature of the Test: The device performs a test on a human biological specimen (fecal specimens) outside of the body ("in vitro") to detect the presence of specific substances (C. difficile Toxin A and B) as an aid in diagnosis. This is the core definition of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Remel's ProSpecT® Clostridium difficile Toxin A/B Microplate Assay is a qualitative enzyme immunoassay (EIA) for the detection of C. difficile Toxin A and B in human fecal specimens from patients suspected of having Clostridium difficile disease. The test is intended for use as an aid in diagnosis of Clostridium difficile-associated disease (CDAD).
Product codes
LLH
Device Description
The ProSpecT® Clostridium difficile Toxin A/B test detects the presence of Toxin A and Toxin B in clinical stool specimens through the use of specific antibodies. Microwell strips are coated with mouse monoclonal anti-Toxin A and rabbit anti-Toxin B antibodies. A stool specimen is diluted in Sample Diluent or used directly if pre-diluted in modified Cary-Blair medium. The sample is added to a microwell allowing the toxins, if present, to bind to the immobilized antibodies. After washing to remove unbound components, a conjugate reagent containing goat anti-Toxin A-HRP and rabbit anti-Toxin B-HRP is added to each well. Unbound conjugate is removed by washing and a chromagenic substrate solution is added to detect the presence of bound toxin. A stop reagent is added and the test results are read visually or spectrophotometrically. The presence of a yellow color indicates the presence of toxin.
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
Not Found
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The performance of the ProSpecT® Clostridium difficile Toxin A/B Microplate Assay was evaluated in a clinical trial at three sites in the USA. The kit and predicate devices were compared to the cellular cytotoxicity assay (CTA).
Overall Performance (Dual Wavelength 450/620-650 nm Results):
Sensitivity: (149/165) x 100 = 90.3%; 95% CI = 84.7% - 94.4%
Specificity: (576/599) x 100 = 96.2%; 95% Cl = 94.3% - 97.5%
ProSpecT® EIA Results (Dual) versus CTA Results:
Positive CTA: 149 ProSpecT® EIA (+), 16 ProSpecT® EIA (-)
Negative CTA: 23 ProSpecT® EIA (+), 576 ProSpecT® EIA (-)
Total Positive CTA: 165
Total Negative CTA: 599
Visual Interpretation of Test:
Sensitivity: (85/100) x 100 = 85.0%; 95% Cl = 76.5% - 91.4%
Specificity: (464/486) x 100 = 95.5%; 95% Cl = 93.2% - 97.1%
ProSpecT® EIA Visual Results versus CTA Results:
Positive CTA: 85 ProSpecT® EIA Visual (+), 15 ProSpecT® EIA Visual (-)
Negative CTA: 22 ProSpecT® EIA Visual (+), 464 ProSpecT® EIA Visual (-)
Total Positive CTA: 100
Total Negative CTA: 486
Percent Agreement (ProSpecT® EIA Visual Results vs. ProSpecT® EIA Results OD 450/620-650): (580/586) x 100 = 99.0%
ProSpecT® EIA Results OD 450/620-650:
Positive: 104 ProSpecT® EIA Visual (+), 3 ProSpecT® EIA Visual (-)
Negative: 3 ProSpecT® EIA Visual (+), 476 ProSpecT® EIA Visual (-)
Total Positive: 107
Total Negative: 479
Comparison to Predicate Devices (Performance versus CTA):
ProSpecT®*: Sensitivity 33/40 (82.5%), Specificity 263/268 (98.1%)
Predicate 1: Sensitivity 33/40 (82.5%), Specificity 260/268 (97.0%)
ProSpecT®: Sensitivity 115/124 (92.7%), Specificity 302/320 (94.3%)
Predicate 2: Sensitivity 98/124 (79.0%), Specificity 309/320 (96.5%)
Reproducibility:
Reproducibility testing was conducted at three sites on three separate days with four blinded samples. Each site tested eight replicate wells of each specimen on each day of testing (n=288). The specimens included one negative specimen and three positive specimens with varying levels of reactivity. The average intra-assay coefficient of variation (CV) for a mid-range sample was 7.7%. The average inter-assay CV for a midrange sample was 18.9%.
Analytical Sensitivity:
The ProSpecT® Clostridium difficile Toxin A/B Microplate Assay detects Toxin A at levels of >0.20 ng/ml and Toxin B at levels of ≥0.61 ng/ml.
Cross-Reactivity:
Forty (40) microorganisms were evaluated. Bacteria and yeast isolates were tested at ≥10^6 colony-forming units per ml (cfu/ml). Viral isolates were tested at concentrations of 10^4 TCID50/ml. No cross-reactivity was observed. There was no cross-reactivity observed with Clostridium sordellii ATCC® 9714. However, published literature indicates that certain strains of C. sordellii can produce toxins which may be cross-reactive with antibodies to C. difficile Toxins A and B.
Interfering Substances:
Tested substances include Vancomycin (12.5 mg/ml), Metronidazole (12.5 mg/ml), blood, mucous, fecal fat, and over-the-counter anti-diarrheal products (Pepto-Bismol®, Imodium® A-D, and Kaopectate®). No interference with positive or negative specimens was observed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity: (149/165) x 100 = 90.3%; 95% CI = 84.7% - 94.4%
Specificity: (576/599) x 100 = 96.2%; 95% Cl = 94.3% - 97.5%
(Visual Interpretation) Sensitivity: (85/100) x 100 = 85.0%; 95% Cl = 76.5% - 91.4%
(Visual Interpretation) Specificity: (464/486) x 100 = 95.5%; 95% Cl = 93.2% - 97.1%
Percent Agreement: (580/586) x 100 = 99.0%
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is: K033479.
- A. Contact: David Teicher Remel Inc. Ramsey Operations 14000 Unity Street NW Ramsev. MN Phone: (763) 712-2367 Fax: (763) 323-7858 e-mail: dteicher@remel.com
Date of Preparation: January 19, 2004 B.
C. Name of Device and Classification
ProSpecT® Clostridium difficile Toxin A/B Microplate Assay Name: Classification: 866.2660 Reagents, Clostridium difficile toxin, Class I, LLH
D. Predicate Devices
| Meridian Premier Toxins A&B: | 510(k) K993914 |
|---|---|
| Wampole C. difficile TOX A/B II: | 510(k) K003306/K971182 |
E. Device Description
The ProSpecT® Clostridium difficile Toxin A/B test detects the presence of Toxin A and Toxin B in clinical stool specimens through the use of specific antibodies. Microwell strips are coated with mouse monoclonal anti-Toxin A and rabbit anti-Toxin B antibodies. A stool specimen is diluted in Sample Diluent or used directly if pre-diluted in modified Cary-Blair medium. The sample is added to a microwell allowing the toxins, if present, to bind to the immobilized antibodies. After washing to remove unbound components, a conjugate reagent containing goat anti-Toxin A-HRP and rabbit anti-Toxin B-HRP is added to each well. Unbound conjugate is removed by washing and a chromagenic substrate solution is added to detect the presence of bound toxin. A stop reagent is added and the test results are read visually or spectrophotometrically. The presence of a yellow color indicates the presence of toxin.
1
Intended Use Statement F.
Remel's ProSpecT® Clostridium difficile Toxin A/B Microplate Assay is a qualitative enzyme immunoassay (EIA) for the detection of C. difficile Toxin A and B in human fecal specimens from patients suspected of having Clostridium difficile disease. The test is intended for use as an aid in diagnosis of Clostridium difficile-associated disease (CDAD).
G. Device Comparison
| Product
| Feature | ProSpect® | Wampole | Merdian |
|---|---|---|---|
| Intended Use | Detection of C. | ||
| difficile Toxins A and | |||
| B in fecal specimens | Detection of C. difficile | ||
| Toxins A and B in fecal | |||
| specimens | Detection of C. difficile | ||
| Toxins A and B in fecal | |||
| specimens | |||
| Technology | Enzyme | ||
| Immunoassay | Enzyme Immunoassay | Enzyme Immunoassay | |
| Capture | |||
| Antibodies or | |||
| Molecules: | |||
| Device | Mouse monoclonal | ||
| anti-Toxin A and | |||
| rabbit anti-Toxin B | Polyclonal goat | ||
| antibody against Toxins | |||
| A and B | Mouse monoclonal anti- | ||
| Toxin A and polyclonal | |||
| goat anti-Toxin B | |||
| Antibodies: | |||
| Conjugate | Goat anti-Toxin A | ||
| and rabbit anti-Toxin | |||
| B | Toxin A monoclonal | ||
| mouse antibody and | |||
| Toxin B polyclonal goat | |||
| antibody | Polyclonal goat anti- | ||
| Toxin A and anti-Toxin | |||
| B | |||
| Material: | |||
| Device | Microwell | Microwell | Microwell |
| Material: | |||
| Conjugate | Horseradish | ||
| peroxidase | |||
| conjugated to anti- | |||
| toxins | Horseradish peroxidase | ||
| conjugated to anti- | |||
| toxins | Horseradish peroxidase | ||
| conjugated to anti- | |||
| toxins | |||
| Specimen | |||
| Type | Fresh human stool | ||
| specimens or | |||
| specimens in | |||
| modified Cary-Blair | Fresh human stool | ||
| specimens | Fresh human stool | ||
| specimens | |||
| Sample | |||
| volume | 200 μl | 50 μl | 50 μl |
2
Summary of Performance Data H.
The performance of the ProSpecT® Clostridium difficile Toxin A/B Microplate Assay was evaluated in a clinical trial at three sites in the USA. The kit and predicate devices were compared to the cellular cytotoxicity assay (CTA).
Overall Performance:
Dual Wavelength (450/620-650 nm) Results:
Sensitivity: (149/165) x 100 = 90.3%; 95% CI = 84.7% - 94.4% Specificity: (576/599) x 100 = 96.2%; 95% Cl = 94.3% - 97.5%
| CTA Results | |||
|---|---|---|---|
| + | - | ||
| ProSpecT® EIA | |||
| Results (Dual) | + | 149 | 23 |
| - | 16 | 576 | |
| Total | 165 | 599 |
Visual Interpretation of Test:
Sensitivity: (85/100) x 100 = 85.0%; 95% Cl = 76.5% - 91.4% Specificity: (464/486) x 100 = 95.5%; 95% Cl = 93.2% - 97.1%
| CTA Results | ||
|---|---|---|
| + | - | |
| ProSpecT® EIA | ||
| Visual Results | 85 | 22 |
| - | 15 | 464 |
| Total | 100 | 486 |
Percent Agreement: (580/586) x 100 = 99.0%
| | ProSpecT® EIA Results
OD 450/620-650 | |
|---------------------------------|-----------------------------------------|-----|
| | + | - |
| ProSpecT® EIA
Visual Results | 104 | 3 |
| - | 3 | 476 |
| Total | 107 | 479 |
3
| EIA | Performance versus CTA | |||
|---|---|---|---|---|
| Sensitivity | Specificity | |||
| # | % | # | % | |
| ProSpecT®* | 33/40 | 82.5 | 263/268 | 98.1 |
| Predicate 1 | 33/40 | 82.5 | 260/268 | 97.0 |
| ProSpecT® | 115/124 | 92.7 | 302/320 | 94.3 |
| Predicate 2 | 98/124 | 79.0 | 309/320 | 96.5 |
Comparison to Predicate Devices:
Reproducibility l.
Reproducibility testing was conducted at three sites on three separate days with four blinded samples. Each site tested eight replicate wells of each specimen on each day of testing (n=288). The specimens included one negative specimen and three positive specimens with varying levels of reactivity. The average intra-assay coefficient of variation (CV) for a mid-range sample was 7.7%. The average inter-assay CV for a midrange sample was 18.9%.
Analytical Sensitivity J.
The ProSpecT® Clostridium difficile Toxin A/B Microplate Assay detects Toxin A at levels of >0.20 ng/ml and Toxin B at levels of ≥0.61 ng/ml.
Cross-Reactivity K.
Forty (40) microorganisms were evaluated with the ProSpecT® Clostridium difficile Toxin A/B Microplate Assay. Bacteria and yeast isolates were tested at ≥10° colony-forming units per ml (cfu/ml). Viral isolates were tested at concentrations of 104 TCIDso/ml (tissue culture infectious dose per milliliter). No cross-reactivity was observed. There was no cross-reactivity observed with Clostridium sordellii ATCC® 9714. However, published literature indicates that certain strains of C. sordellii can produce toxins which may be cross-reactive with antibodies to C. difficile Toxins A and B. The following organisms were tested in the ProSpecT® Clostridium difficile Toxin A/B Microplate Assay.
| Organism | ATCC® designation |
|---|---|
| Aeromonas hydrophila | 35654 |
| Bacillus cereus | 11778 |
| Bacillus subtilis | 6633 |
| Bacteriodes fragilis | 25285 |
| Campylobacter coli | 33559 |
| Campylobacter jejuni | 33291 |
| Candida albicans | 10231 |
4
510(k) Submission Remel Inc. ProSpecT® Clostridium difficile Toxin A/B Microplate Assay
| Organism | ATCC® designation |
|---|---|
| Clostridium beijerinckii (butyricum) | 8260 |
| Clostridium difficile (non-toxigenic) | 700057 |
| Clostridium haemolyticum | 9650 |
| Clostridium histolyticum | 19401 |
| Clostridium novyi (toxin A) | 19402 |
| Clostridium perfringens (Type A) | 13124 |
| Clostridium septicum | 12464 |
| Clostridium sordellii | 9714 |
| Clostridium sporogenes | 19404 |
| Clostridium tetani | 19406 |
| Enterobacter aerogenes | 35028 |
| Enterobacter cloacae | 13047 |
| Enterococcus faecalis | 19433 |
| Escherichia coli | 11229 |
| Klebsiella pneumoniae | 13882 |
| Peptostreptococcus anaerobius | 27337 |
| Porphyromonas asaccharolytica | 25260 |
| Proteus vulgaris | 49132 |
| Pseudomonas aeruginosa | 27853 |
| Salmonella choleraesuis (typhimurium) | 23852 |
| Serratia liquefaciens | 27592 |
| Shigella dysenteriae | 11835 |
| Shigella flexneri | 12022 |
| Shigella sonnei | 25931 |
| Staphylococcus aureus | 25923 |
| Staphylococcus aureus (Cowan) | 12598 |
| Staphylococcus epidermidis | 12228 |
| Vibrio cholerae | 9459 |
| Vibrio parahaemolyticus | 17802 |
| Yersinia enterocolitica | 23715 |
| Adenovirus type 40 | VR-930 |
| Adenovirus type 41 | VR-931 |
| Rotavirus (Complement fixation antigen) |
Rotavirus (Complement fixation antigen)
Interfering Substances ட்ட
The following substances were tested with the ProSpecT® Clostridium difficile Toxin A/B Microplate Assay: Vancomycin (12.5 mg/ml), Metronidazole (12.5 mg/ml), blood, mucous, fecal fat, and the following over-the-counter anti-diarrheal products: Pepto-Bismol®, Imodium® A-D, and Kaopectate® (active ingredients: bismuth subsalicylate, loperamide HCl. and attapugite respectively). No interference with positive or negative specimens was observed.
5
Image /page/5/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features an abstract design resembling an eagle or bird-like figure, with three stylized lines forming the body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the central emblem.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
FEB 2 6 2004
Mr. David Teicher Manager Quality Systems and Regulatory Affairs Remel Inc. Ramsey Operation 14000 Unity Street NW Ramsey, MN 55303
K033479 Re:
Trade/Device Name: ProSpecT® C. difficile Toxin A/B Microplate Assay Regulation Number: 21 CFR 866.2660 Regulation Name: Microorganism differentiation and identification device Regulatory Class: Class I Product Code: LLH Dated: January 19, 2004 Received: January 20, 2004
Dear Mr. Teicher:
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 either class II (Special Controls) or class III (PMA), 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
6
Page 2
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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Saqartys
Sally A. Hojvat, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
7
Indications for Use
510(k) Number (if known): K033479
Device Name: ProSpecT® C. difficile Toxin A/B Microplate Assay
Indications For Use:
Remel's ProSpecT® Clostridium difficile Toxin A/B Microplate Assay is a qualitative enzyme immunoassay (EIA) for the detection of C. difficile Toxin A and B in human fecal specimens from patients suspected of having Clostridium difficile disease. The test is intended for use as an aid in diagnosis of Clostridium difficileassociated disease (CDAD).
For In vitro Diagnostic Use.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Luddi te Palo.
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K033479
Page 1 of 1