(118 days)
BD ColorPAC™ Toxin A
Not Found
No
The device description and performance studies indicate a standard immunochromatographic assay, with no mention of AI or ML technologies.
No
The device is an in vitro diagnostic test intended as an aid in diagnosis, not for therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the test is "intended for use as an aid in diagnosis of CDAD."
No
The device description clearly outlines a physical immunochromatographic assay kit with reagents and a test device, indicating it is a hardware-based medical 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 a "rapid in vitro immunochromatographic test for the direct, qualitative detection of Clostridium difficile Toxin A and/or B in human fecal specimens". The term "in vitro" is a key indicator of an IVD.
- Device Description: The description details a test performed on a biological sample (human fecal specimens) outside of the body, using reagents and a test device to detect specific analytes (Clostridium difficile Toxin A and B). This aligns with the definition of an in vitro diagnostic test.
- Performance Studies: The document describes clinical accuracy studies comparing the device's performance to a reference method (cytotoxin assay) using human fecal specimens. This type of testing and evaluation is characteristic of IVD devices.
N/A
Intended Use / Indications for Use
REMEL's Xpect™ Clostridium difficile Toxin A/B is a rapid in vitro immunochromatographic test for the direct, qualitative detection of Clostridium difficile Toxin A and/or B in human fecal specimens from patients suspected of having Clostridium difficile-associated disease (CDAD). The test is intended for use as an aid in diagnosis of CDAD. The test can also be used for confirmation of toxigenic Clostridium difficile from Brain Heart Infusion (BHI) broth culture.
Product codes (comma separated list FDA assigned to the subject device)
LLH
Device Description
The Xpect™ Clostridium difficile Toxin A/B test is a qualitative immunochromatographic assay that detects C. difficile Toxin A and Toxin B in stool specimens or cultures of toxigenic C. difficile. In performing the test, a specimen is first diluted with Specimen Diluent to help solubilize the toxins. A portion of the diluted sample is then mixed with a volume of Conjugate 1 containing antibodies to Toxin A and Toxin B coupled to colored microparticles, plus a volume of Conjugate 2 containing biotinylated antibodies to Toxin A and Toxin B. A volume of this mixture is transferred to a test device having immobilized streptavidin as a test line and goat antiimmunoqlobulin antibody a as a control line. Immunocomplexes of toxin and conjugated antibodies form a visible band as they flow across the test line. Excess colored particle conjugates form a visible band at the control line to document that the test is functioning properly.
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)
Clinical Accuracy: The performance of the Xpect™ Clostridium difficile Toxin A/B was evaluated at four geographically diverse regions of the United States. A total of eight hundred fifteen specimens were tested with the Xpect™ Clostridium difficile Toxin A/B test and compared to results obtained from the cytotoxin assay (CTA). Sensitivity: 86.3% (95% CI = 79.8-91.3%), Specificity: 96.2% (95% Cl = 94.5-97.5%), Positive Predictive Value: 84.1% (95% C1 = 77.4-89.4%), Negative Predictive Value: 96.8% (95% Cl = 95.2=98.0%), % Correlation: 94.4% (95% Cl = 92.5-95.8%).
BHI Broth Culture Performance: An in-house study was conducted using twenty-one known reference strains and thirty-six suspect Clostridium difficile isolates from stool specimens. BHI broth cultures were tested with the Xpect™ Clostridium difficile Toxin A/B test following 72hours incubation. Under these conditions, the BHI broth culture of Clostridium sordellii ATCC® 9714 produced a positive reaction. There was 94.7% (54/57) agreement with expected values.
Analytical Sensitivity: The analytical sensitivity was evaluated using purified C. difficile Toxin A and Toxin B. Xpect™ C. difficile Toxin A/B assay detects Toxin A at levels of ≥ 6.25 ng/ml (0.12 ng/test device) and Toxin B at levels of ≥ 40.0 ng/ml (0.76 ng/test device).
Cross-Reactivity: Fifty-four microorganisms were evaluated with the Xpect™ C. difficile Toxin A/B test. No cross-reactivity was observed.
Reproducibility: Reproducibility testing was conducted at three sites, including one in-house site, on four separate days with six blinded samples. The samples consisted of known positive and negative stool specimens. The samples produced the expected result with the Xpect™ C. difficile Toxin A/B test 98.6% (71/72) of the time.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity: 86.3% (95% CI = 79.8-91.3%)
Specificity: 96.2% (95% Cl = 94.5-97.5%)
Positive Predictive Value: 84.1% (95% C1 = 77.4-89.4%)
Negative Predictive Value: 96.8% (95% Cl = 95.2=98.0%)
% Correlation: 94.4% (95% Cl = 92.5-95.8%)
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.
BD ColorPAC™ Toxin A
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
§ 866.2660 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
NOV 1 5 2004
510(k) SUMMARY
| Contact Information: | Mary Ann Silvius |
|---|---|
| Director, Business & Product Development | |
| Remel Inc. | |
| 12076 Santa Fe Drive | |
| Lenexa, KS 66215 | |
| Phone: (913) 895-4054 | |
| Fax: (913) 895-4054 | |
| email: msilvius@remel.com |
July 16, 2004 Date Prepared:
Xpect™ Clostridium difficile Toxin A/B Device Trade Name:
BD ColorPAC™ Toxin A Predicate Device:
21 CFR 866.2660; Microorganism differentiation and Device Classification: identification device: reagents, Clostridium difficile toxin.
REMEL's Xpect™ Clostridium difficile Toxin A/B is a rapid Intended Use: in vitro immunochromatographic test for the direct, qualitative detection of Clostridium difficile Toxin A and/or B in human fecal specimens from patients suspected of having Clostridium difficile-associated disease (CDAD). The test is intended for use as an aid in diagnosis of CDAD. The test can also be used for confirmation of toxigenic Clostridium difficile from Brain Heart Infusion (BHI) broth culture.
The Xpect™ Clostridium difficile Toxin A/B test is a Device Description: qualitative immunochromatographic assay that detects C. difficile Toxin A and Toxin B in stool specimens or cultures of toxigenic C. difficile. In performing the test, a specimen is first diluted with Specimen Diluent to help solubilize the toxins. A portion of the diluted sample is then mixed with a volume of Conjugate 1 containing antibodies to Toxin A and Toxin B coupled to colored microparticles, plus a volume of Conjugate 2 containing biotinylated antibodies to Toxin A and Toxin B. A volume of this mixture is transferred to a test device having immobilized streptavidin as a test line and goat antiimmunoqlobulin antibody a as ત્વ control line. Immunocomplexes of toxin and conjugated antibodies form a visible band as they flow across the test line. Excess colored particle conjugates form a visible band at the control line to document that the test is functioning properly.
1
Device Comparison:
| Characteristic | ColorPAC™ Toxin A | Xpect™ C. difficile Toxin A/B |
|---|---|---|
| Intended Use | ColorPAC™ Toxin A is a rapid | |
| chromatographic assay for the qualitative | ||
| detection of Clostridium difficile Toxin A | ||
| (enterotoxin) in stool specimens from | ||
| patients suspected of having C. difficile- | ||
| associated disease. The test can also be | ||
| used for confirmation of suspect colonies | ||
| of toxigenic C. difficile from agar plates or | ||
| BHI Broth. This assay is intended for use | ||
| as an aid in the diagnosis of C. difficile- | ||
| associated disease. | REMEL's Xpect™ Clostridium difficile A/B | |
| test kit is a rapid in vitro | ||
| immunochromatographic test for the | ||
| direct, qualitative detection of Clostridium | ||
| difficile Toxin A and/or B in human fecal | ||
| specimens from patients suspected of | ||
| having Clostridium difficile-associated | ||
| disease (CDAD). The test is intended for | ||
| use as an aid in diagnosis of CDAD. The | ||
| test can also be used for confirmation of | ||
| toxigenic Clostridium difficile from Brain | ||
| Heart Infusion (BHI) broth culture. | ||
| Detection | Qualitative; Toxin A only detected. | Qualitative; Toxin A and Toxin B detected. |
| Technology | Chromatographic membrane assay | Immunochromatographic membrane |
| assay | ||
| Specimen Type | Fecal specimens, colonies, BHI Broth | Fecal specimens, BHI Broth |
Summary of Performance Data:
Clinical Accuracy:
The performance of the Xpect™ Clostridium difficile Toxin A/B was evaluated at four geographically diverse regions of the United States. A total of eight hundred fifteen specimens were tested with the Xpect™ Clostridium difficile Toxin A/B test and compared to results obtained from the cytotoxin assay (CTA).
| CTA Results | ||
|---|---|---|
| Overall | + | - |
| XpectTM | ||
| Results | 132 | 25 |
| 21 | 637 | |
| TOTAL | 153 | 662 |
Sensitivity: 86.3% (95% CI = 79.8-91.3%) Specificity: 96.2% (95% Cl = 94.5-97.5%) Positive Predictive Value: 84.1% (95% C1 = 77.4-89.4%) Negative Predictive Value: 96.8% (95% Cl = 95.2=98.0%) % Correlation: 94.4% (95% Cl = 92.5-95.8%)
Note : CI = Confidence Interval
Discordant results were further investigated by toxigenic culture and microwell enzyme immunoassay that detects both Toxin A and B. Four of 25 specimens that were cytotoxin negative and Xpect™ Clostridium difficile Toxin A/B positive on initial testing were positive by toxigenic culture and enzyme immunoassay. Ten of 21 (47.6%) specimens that were CTA positive and Xpect™ Clostridium difficile Toxin A/B negative on initial testing were negative by toxigenic culture and microwell enzyme immunoassay.
2
Performance Compared to Commercially Available Devices:
The Xpect™ C. difficile Toxin A/B test was also compared to two commercially available rroducts. Each of the four clinical trial sites tested a chromatographic membrane assay that detects Toxin A only (Predicate Device), the Xpect™ C. difficile Toxin A/B test, and indi Golocie Toxil TTA) for each sample. In addition, one clinical trial site tested a microwell enzyme immunoassay for the detection of both Toxin A and B for each sample. The results presented below are calculated using CTA as the reference.
| n = 815 | n = 267 | |||
|---|---|---|---|---|
| Xpect™ | ||||
| C. difficile Toxin A/B | Predicate | |||
| Device | Xpect™ | |||
| C. difficile Toxin A/B | EIA | |||
| Sensitivity | 86.3% | 62.7% | 91.0% | 80.6% |
| Specificity | 96.2% | 98.8% | 98.0% | 97.5% |
| Agreement | 94.4% | 92.0% | 96.3% | 93.3% |
BHI Broth Culture Performance:
An in-house study was conducted using twenty-one known reference strains and thirty-six suspect Clostridium difficile isolates from stool specimens. BHI broth cultures were tested with the Xpect™ Clostridium difficile Toxin A/B test following 72hours incubation. Under these conditions, the BHI broth culture of Clostridium sordellii ATCC® 9714 produced a positive reaction. There was 94.7% (54/57) agreement with expected values.
Analytical Sensitivity:
The analytical sensitivity was evaluated using purified C. difficile Toxin A and Toxin B. Xpect™ C. difficile Toxin A/B assay detects Toxin A at levels of ≥ 6.25 ng/ml (0.12 ng/test device) and Toxin B at levels of ≥ 40.0 ng/ml (0.76 ng/test device).
Cross-Reactivity:
Fifty-four microorganisms were evaluated with the Xpect™ C. difficile Toxin A/B test. No cross-reactivity was observed. Bacteria and yeast isolates were tested at 10° colony-forming units per ml concentration. Viral isolates were tested at concentrations of 104 to 105 TCID50 (tissue culture infectious dose) per ml concentration. The following organisms were tested in the Xpect™ C. difficile Toxin A/B test.
| Aeromonas hydrophila | Proteus mirabilis |
|---|---|
| Bacillus cereus | Proteus vulgaris |
| Bacillus subtilis | Pseudomonas aeruginosa |
| Bacteroides fragilis | Salmonella Typhimurium |
| Campylobacter coli | Serratia liquefaciens |
| Campylobacter fetus subsp. fetus | Shigella boydii |
| Campylobacter jejuni subsp. jejuni | Shigella dysenteriae |
| Campylobacter lari | Shigella flexneri |
| Candida albicans | Shigella sonnei |
| Clostridium botulinum (toxin 20 µg/ml) | Staphylococcus aureus |
| Clostridium beijerinickii | (Cowan) |
| Clostridium difficile (non-toxigenic) | Staphylococcus epidermidis |
3
Clostridium haemolyticum Clostridium histolyticum Clostridium innocuum Clostridium novvi Clostridium perfringens Clostridium septicum Clostridium sordellii Clostridium sporogenes Clostridium subterminale Clostridium tetani Enterobacter aerogenes Enterobacter cloacae Enterococcus faecalis Enterococcus faecium Escherichia coli Klebsiella pneumoniae Peptostreptococcus anaerobius Porphyromonas asaccharolytica
Vibrio cholerae Vibrio parahaemolvticus Yersinia enterocolitica Giardia intestinalis Entamoeba histolytica Adenovirus type 2 Adenovirus tvpe 40 Adenovirus type 41 Coxsackievirus B4 Cytomegalovirus Echovirus (type 22) Enterovirus (type 69) Rotavirus
Interfering Substances:
The following substances were tested with the Xpect™ C. difficile Toxin A/B test and no interference was observed in the assay for any substance tested at the indicated levels: blood, mucous, fecal fat, Pepto-Bismol® (10%V/v), Imodium® AD (10%v/v), Kaopectate® (10%v/v), Castoria® (10%v/v), vancomycin (12.5 mg/ml), metronidazole (12.5 mg/ml), and barium sulfate (12.5 mg/ml).
Reproducibility:
Reproducibility testing was conducted at three sites, including one in-house site, on four separate days with six blinded samples. The samples consisted of known positive and negative stool specimens. The samples produced the expected result with the Xpect™ C. difficile Toxin A/B test 98.6% (71/72) of the time.
4
Image /page/4/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 a stylized image of an eagle with three curved lines representing its wings.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Nov 1 5 2004
Ms. Mary Ann Silvius Director. Business and Product Development Remel Inc. 12076 Santa Fe Drive Lenexa, KS 66215
Re: K041951 Trade/Device Name: Xpect TM Clostridium difficile Toxin A/B Regulation Number: 21 CFR 866.2660 Regulation Name: Microorganism Differentiation and Identification Device Regulatory Class: Class I Product Code: LLH Dated: October 19, 2004 Received: October 22, 2004
Dear Ms. Silvius:
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).
5
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,
Salartys
Sally A. Hoivat. 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
6
INDICATIONS FOR USE
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name: Xpect™ Clostridium difficile Toxin A/B
Indications For Use: REMEL's Xpect™ Clostridium difficile Toxin A/B is a rapid in vitro immunochromatographic test for the direct, qualitative detection of Clostridium difficile Toxin A and/or B in human fecal specimens from patients suspected of having Clostridium difficileassociated disease (CDAD). The test is intended for use as an aid in diagnosis of CDAD. The test can also be used for confirmation of toxigenic Clostridium difficile from Brain Heart Infusion (BHI) broth culture.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Freddie A. Coode
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Salety
Page 1 of 1
510(k) K041951