(209 days)
C. difficult Culture Media, C. DIFF CHEK™ - 60 K030992, BD CULTURETTE™ CDT™ K870864, Triage® Micro C. difficile Panel, GDH portion K974881, ImmunoCard® C. difficile EIA K924979, Tissue culture assay (TOX-B TEST) K935296, Premier™ Toxins A&B K993914, ProSpecT® Clostridium difficile Toxin A/B K033479, ImmunoCard® Toxins A&B K041003, X/pect™ Clostridium difficile Toxin A/B K041951, TOX A/B QUIK CHEK® test K050891
No
The device description details a traditional enzyme immunoassay with visual interpretation of results based on the appearance of colored lines. There is no mention of algorithms, data processing, or automated interpretation that would suggest the use of AI/ML.
No
The device is an in vitro diagnostic (IVD) test used to aid in the diagnosis of C. difficile disease by detecting specific antigens and toxins in fecal specimens. It does not provide therapy or treatment.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states, "The test is to be used as an aid in the diagnosis of C. difficile disease." and "FOR IN VITRO DIAGNOSTIC USE."
No
The device description clearly outlines a physical test kit with reagents, a reaction window, and a membrane, indicating it is a hardware-based in vitro diagnostic device, not software only.
Yes, this device is an IVD (In Vitro Diagnostic).
The document explicitly states: "FOR IN VITRO DIAGNOSTIC USE." in the Intended Use / Indications for Use section. This is the primary indicator that the device is intended for use outside of the body to examine specimens for diagnostic purposes.
N/A
Intended Use / Indications for Use
The C. DIFF QUIK CHEK COMPLETE™ test is a rapid membrane enzyme immunoassay for the simultaneous detection of C. difficile glutamate dehydrogenase antigen and toxins A and B in a single reaction well. The test detects C. difficile antigen, glutamate dehydrogenase, as a screen for the presence of C. difficile and confirms the presence the toxigenic C. difficile by detecting toxins A and B in fecal specimens from persons suspected of having C. difficile disease. The test is to be used as an aid in the diagnosis of C. difficile disease. As with other C. difficile tests, results should be considered in conjunction with the patient history.
FOR IN VITRO DIAGNOSTIC USE.
Product codes
LLH
Device Description
The C. DIFF QUIK CHEK COMPLETE™ test uses antibodies specific for qlutamate dehydrogenase (GDH) and Toxins A and B of C. difficile. The device contains a Reaction Window with two solid lines and a dotted line of immobilized antibodies. The Antigen line ("Ag") contains antibodies against C. difficile GDH. The Toxin line ("Tox") contains antibodies against C. difficile toxins A and B. The dotted line, representing a control line ("C"), contains anti-HRP antibodies. The Conjugate consists of antibodies to GDH, toxin A, and toxin B coupled to horseradish peroxidase. To perform the test, the fecal specimen is diluted with Diluent, and Conjugate is added to the diluted sample. The diluted sample-conjugate mixture is added to the Sample Well and the device is allowed to incubate at room temperature for 15 minutes. During the incubation, any GDH, toxin A or toxin B in the sample binds to the corresponding antibody-peroxidase conjugate. The antigen-antibody complexes migrate through a filter pad to a membrane where they are captured by the immobilized anti-GDH, anti-toxin A or Anti-toxin B antibody in the line. The Reaction Window is subsequently washed with Wash Buffer, followed by the addition of Substrate. After a 10-minute incubation, the "Ag" and "Tox" reaction is examined visually for the appearance of a blue line. A blue line indicates a positive test. A positive "C" reaction, indicated by a blue dotted line, confirms that sample and all reagents were added in proper sequence and volume, that reagents were active at the time of performing the assay, and that proper sample migration occurred.
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 For GDH antigen:
The results show that the C. DIFF QUIK CHEK COMPLETE™ test exhibited a correlation of 92.6% with bacterial culture (n=1126).
The C. DIFF QUIK CHEK COMPLETE™ test detected 98.7% of the tissue culture-positive samples (n=1126).
Clinical Accuracy For Toxins A and B:
The results show that the C. DIFF QUIK CHEK COMPLETE™ test exhibited a sensitivity and specificity of 87,8% and 99,4%, respectively, compared to the tissue culture assay (n=1126). The predictive positive and negative values were 95.8% and 98.1%, respectively, and the correlation was 97.8%.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
For GDH antigen compared to Bacterial Culture (n=1126):
Sensitivity: 90.5% (95% Confidence Limits: 85.7 - 93.9)
Specificity: 93.1% (95% Confidence Limits: 91.2 - 94.7)
Predictive Positive Value: 76.4% (95% Confidence Limits: 70.7 - 81.3)
Predictive Negative Value: 97.6% (95% Confidence Limits: 96.2 - 98.4)
Correlation: 92.6% (95% Confidence Limits: 91.8 - 93.4)
For GDH antigen compared to Tissue Culture Assay (n=1126):
Percent Positive Agreement: 98.7% (95% Confidence Limits: 95.0 - 99.8)
Percent Negative Agreement: 88.8% (95% Confidence Limits: 86.6 - 90.6)
Overall Percent Agreement: 90.1% (95% Confidence Limits: 89.0 - 91.1)
For Toxins A and B compared to Tissue Culture Assay (n=1126):
Sensitivity: 87.8% (95% Confidence Limits: 81.4 - 92.3)
Specificity: 99.4% (95% Confidence Limits: 98.6 - 99.7)
Predictive Positive Value: 95.8% (95% Confidence Limits: 90.7 - 98.3)
Predictive Negative Value: 98.1% (95% Confidence Limits: 96.9 - 98.8)
Correlation: 97.8% (95% Confidence Limits: 97.6 - 98.0)
Predicate Device(s)
C. DIFF QUIK CHEK® test K053572, C. DIFFICILE TOX A/B II™ K003306
Reference Device(s)
C. difficile Culture Media, C. DIFF CHEK™ - 60 K030992, BD CULTURETTE™ CDT™ K870864, Triage® Micro C. difficile Panel, GDH portion K974881, ImmunoCard® C. difficile EIA K924979, Tissue culture assay (TOX-B TEST) K935296, Premier™ Toxins A&B K993914, ProSpecT® Clostridium difficile Toxin A/B K033479, ImmunoCard® Toxins A&B K041003, X/pect™ Clostridium difficile Toxin A/B K041951, TOX A/B QUIK CHEK® test K050891
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
Image /page/0/Picture/1 description: The image contains a sequence of handwritten alphanumeric characters. The characters are 'K', 'o', '8', '2', '4', '9', and '9'. The characters are written in a dark ink on a white background.
510(k) SUMMARY 7.
| Contact Information | Charles Pennington
Director of Product Development
TECHLAB®, Inc.
2001 Kraft Drive
Corporate Research Center
Blacksburg, VA 24060
Phone: 540-953-1664
FAX: 540-953-1665
Email: cpennington@techlab.com | MAR 2 6 2009 |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Date Prepared | August 28, 2008 | |
| Product and Trade Name | C. DIFF QUIK CHEK COMPLETE™ | |
| Classification | 21 CFR 866.2660 | |
Predicate Devices
For the detection of GDH antigen
- C. difficile Culture Media such as cycloserine cefoxitin fructose agar (CCFA) is . available commercially from various sources.
- C. DIFF QUIK CHEK® �
- C. DIFF CHEK™ 60 ●
- BD CULTURETTE™ CDT™ ◆
- ImmunoCard® C. difficile EIA �
For the detection of Toxins A and B
- C. DIFFICILE TOX-B TEST and C. difficile Toxin/Antitoxin along with human foreskin . monolayer tissue cultured cells (Diagnostic Hybrids, Inc.). Alternatively, clinical laboratories may use their own tissue cultured monolayer cells.
- TOX A/B QUIK CHEK® �
- C. DIFFICILE TOX A/B I™ .
- Premier™ Toxins A&B .
- ProSpecT® Clostridium difficile Toxin A/B .
- ImmunoCard® Toxins A&B .
- X/pect™ Clostridium difficile Toxin A/B .
For the simultaneous detection of GDH antigen and Toxin A
- Biosite Triage® Micro Clostridium difficile Panel .
1
Intended Use
The C. DIFF QUIK CHEK COMPLETE™ test is a rapid membrane enzyme immunoassay for the simultaneous detection of C. difficile glutamate dehydrogenase antigen and toxins A and B in a single reaction well. The test detects C. difficile antigen, glutamate dehydrogenase, as a screen for the presence of C. difficile and confirms the presence the toxigenic C. difficile by detecting toxins A and B in fecal specimens from persons suspected of having C. difficile disease. The test is to be used as an aid in the diagnosis of C. difficile disease. As with other C. difficile tests, results should be considered in conjunction with the patient history.
Device Description
The C. DIFF QUIK CHEK COMPLETE™ test uses antibodies specific for qlutamate dehydrogenase (GDH) and Toxins A and B of C. difficile. The device contains a Reaction Window with two solid lines and a dotted line of immobilized antibodies. The Antigen line ("Ag") contains antibodies against C. difficile GDH. The Toxin line ("Tox") contains antibodies against C. difficile toxins A and B. The dotted line, representing a control line ("C"), contains anti-HRP antibodies. The Conjugate consists of antibodies to GDH, toxin A, and toxin B coupled to horseradish peroxidase. To perform the test, the fecal specimen is diluted with Diluent, and Conjugate is added to the diluted sample. The diluted sample-conjugate mixture is added to the Sample Well and the device is allowed to incubate at room temperature for 15 minutes. During the incubation, any GDH, toxin A or toxin B in the sample binds to the corresponding antibody-peroxidase conjugate. The antigen-antibody complexes migrate through a filter pad to a membrane where they are captured by the immobilized anti-GDH, anti-toxin A or Anti-toxin B antibody in the line. The Reaction Window is subsequently washed with Wash Buffer, followed by the addition of Substrate. After a 10-minute incubation, the "Ag" and "Tox" reaction is examined visually for the appearance of a blue line. A blue line indicates a positive test. A positive "C" reaction, indicated by a blue dotted line, confirms that sample and all reagents were added in proper sequence and volume, that reagents were active at the time of performing the assay, and that proper sample migration occurred.
2
Comparative Information of Equivalent Devices For detection of GDH antigen:
| Characteristics | 510(k) Numbers | Intended Use | Format | Materials | Target
Population |
|------------------------------------------------------------|-----------------------------------------------------|--------------------------------------------------------------------------|----------------------------------|---------------------------------------------------------------------------|---------------------------------------------------------------------|
| C. difficile
Cacterial Culture | Used
before
1976,
510(k) not
available. | Detection of
C. difficile
organism in
fecal
specimens | Bacterial
culture | Specific
selective media,
CCFAa plates
and CC BHIb
broth | Persons
suspected of
having
C. difficile
disease |
| C. DIFF CHEK TM
- 60 | K030992 | Detection of
C. difficile
organism in
fecal
specimens | ELISA | Highly specific
antibodies
against
C. difficile GDH | Persons
suspected of
having
C. difficile
disease |
| BD
CULTURETTETM
CDTTM | K870864 | Detection of
C. difficile
organism in
fecal
specimens | Latex
agglutination | Antibodies
against
C. difficile GDH
and other
proteins | Persons
suspected of
having
C. difficile
disease |
| Triage® Micro
C. difficile Panel,
GDH portion | K974881 | Detection of
C. difficile
organism in
fecal
specimens | Flow through
membrane
test | Highly specific
antibodies
against
C. difficile GDH | Persons
suspected of
having
C. difficile
disease |
| ImmunoCard®
C. difficile EIA | K924979 | Detection of
C. difficile
organism in
fecal
specimens | Lateral flow
membrane
test | Highly specific
antibodies
against
C. difficile GDH | Persons
suspected of
having
C. difficile
disease |
| C. DIFF QUIK
CHEK ® test | K053572 | Detection of
C. difficile
organism in
fecal
specimens | Rapid
membrane | Highly specific
antibodies
against
C. difficile GDH | Persons
suspected of
having
C. difficile
disease |
| Characteristics | 510(k) Numbers | Intended Use | Format | Materials | Target Population |
| Tissue culture assay (TOX-B TEST) | K935296 | Detection of C. difficile toxin in fecal specimens | Tissue culture | Cell monolayer, specific neutralizing antiserum | Persons suspected of having C. difficile disease |
| C. DIFFICILE TOX A/B II
TM | K003306 and K030404 | Detection of C. difficile toxin in fecal specimens | Microassay ELISA | Highly specific antibodies against C. difficile toxins A and B | Persons suspected of having C. difficile disease |
| PremierTM Toxins A&B | K993914 | Detection of C. difficile toxin in fecal specimens | Microassay ELISA | Highly specific antibodies against C. difficile toxins A and B | Persons suspected of having C. difficile disease |
| ProSpecT® Clostridium difficile Toxin A/B | K033479 | Detection of C. difficile toxin in fecal specimens | Microassay ELISA | Highly specific antibodies against C. difficile toxins A and B | Persons suspected of having C. difficile disease |
| ImmunoCard® Toxins A&B | K041003 | Detection of C. difficile toxin in fecal specimens | Rapid membrane | Highly specific antibodies against C. difficile toxins A and B | Persons suspected of having C. difficile disease |
| X/pectTM Clostridium difficile Toxin A/B | K041951 | Detection of C. difficile toxin in fecal specimens | Rapid membrane | Highly specific antibodies against C. difficile toxins A and B | Persons suspected of having C. difficile disease |
| TOX A/B QUIK CHEK® test | K050891 | Detection of C. difficile toxin in fecal specimens | Rapid membrane | Highly specific antibodies against C. difficile toxins A and B | Persons suspected of having C. difficile disease |
a, CCFA, cycloserine - cefoxitin fructose agar plates
r.
b, CC-BHI, cycloserine - cefoxitin brain-heart infusion liquid media
3
For detection of toxins A and B:
· .
4
Summary of Performance Data Clinical Accuracy For GDH antigen
The following tables show a summary of the clinical performance of the GDH antigen portion of the C. DIFF QUIK CHEK COMPLETE™ test. The discrepant samples generated from the C. DIFF QUIK CHEK COMPLETE™ and bacterial culture assay were resolved using the C. DIFFICILE CHEK™ - 60 ELISA, which detects GDH antigen. The protocols are presented in the Appendices. The results show that the C. DIFF QUIK CHEK COMPLETE™ test exhibited a correlation of 92.6% with bacterial culture.
Clinical Performance Comparing C. DIFF QUIK CHEK COMPLETE™ Test to Bacterial Culture
| n= 1126 | Bacterial Culture
positive | Bacterial Culture
negative |
|------------------------------------------------------|-------------------------------|-------------------------------|
| C. DIFF QUIK CHEK COMPLETE™
Antigen Line Positive | 201 | 62 |
| C. DIFF QUIK CHEK COMPLETE™
Antigen Line Negative | 21 | 842 |
| | | 95% Confidence
Limits |
|---------------------------|-------|--------------------------|
| Sensitivity | 90.5% | 85.7 - 93.9 |
| Specificity | 93.1% | 91.2 - 94.7 |
| Predictive Positive Value | 76.4% | 70.7 - 81.3 |
| Predictive Negative Value | 97.6% | 96.2 - 98.4 |
| Correlation | 92.6% | 91.8 - 93.4 |
Twenty-nine of the 62 false positive samples were positive by the C. DIFF CHEK™ - 60 ELISA, and were considered true positives. Thirteen of the 21 false negative samples were negative by the ELISA, and were considered true negatives.
5
Comparison of the GDH antigen portion to tissue culture assay
The following table shows a comparison of the GDH antigen portion of the C. DIFF QUIK CHEK COMPLETE™ test versus tissue culture assay. The protocols are presented in the Appendices. The results show that the C. DIFF QUIK CHEK COMPLETE™ test detected 98.7% of the tissue culture-positive samples.
Clinical Performance Comparing C. DIFF QUIK CHEK COMPLETE™ Test to Tissue Culture Assay
| n= 1126 | Tissue Culture
positive | Tissue Culture
negative |
|------------------------------------------------------|----------------------------|----------------------------|
| C. DIFF QUIK CHEK COMPLETE™
Antigen Line Positive | 154 | 109 |
| C. DIFF QUIK CHEK COMPLETE™
Antigen Line Negative | 2 | 861 |
| | | 95% Confidence
Limits |
|----------------------------|-------|--------------------------|
| Percent Positive Agreement | 98.7% | 95.0 - 99.8 |
| Percent Negative Agreement | 88.8% | 86.6 - 90.6 |
| Overall Percent Agreement | 90.1% | 89.0 - 91.1 |
Analytical Sensitivity
The cutoff for the assay was established at a concentration of 0.8 ng/mL for Glutamate Dehydrogenase.
6
Summary of Performance Data Clinical Accuracy For Toxins A and B
The following tables show a summary of the clinical performance of the toxins A and B portion of the C. DIFF QUIK CHEK COMPLETE™ test. Results from all 3 clinical sites are included in the summary. Results from the C. DIFF QUIK CHEK COMPLETE™ were compared to tissue culture assay and discrepant results were analyzed by either the C. DIFFICILE TOX A/B I/™ test or a second commercially available Toxin A/B test. The results show that the C. DIFF QUIK CHEK COMPLETE™ test exhibited a sensitivity and specificity of 87,8% and 99,4%, respectively, compared to the tissue culture assay. The predictive positive and negative values were 95.8% and 98.1%, respectively, and the correlation was 97.8%.
Summary of clinical performance comparing the C. DIFF QUIK CHEK COMPLETE™ test versus tissue culture assay.
| n= 1126 | Tissue Culture
positive | Tissue Culture
negative |
|----------------------------------------------------|----------------------------|----------------------------|
| C. DIFF QUIK CHEK COMPLETE™
Toxin Line Positive | 137 | 6 |
| C. DIFF QUIK CHEK COMPLETE™
Toxin Line Negative | 19 | 964 |
| | | 95% Confidence
Limits |
|---------------------------|-------|--------------------------|
| Sensitivity | 87.8% | 81.4 - 92.3 |
| Specificity | 99.4% | 98.6 - 99.7 |
| Predictive Positive Value | 95.8% | 90.7 - 98.3 |
| Predictive Negative Value | 98.1% | 96.9 - 98.8 |
| Correlation | 97.8% | 97.6 - 98.0 |
Of the 6 tissue culture-negative/C. DIFF QUIK CHEK COMPLETE™-positive samples, 5 were positive in the C. DIFFICILE TOX A/B I/™ test. Of the 19 specimens that were tissue culture-positive/C. DIFF QUIK CHEK COMPLETE™-negative, 12 were neqative in the C. DIFFICILE TOX A/B I/™test or a second commercially available Toxin A&B test.
Analytical Sensitivity
The cutoff for the assay was established at concentrations of 0.63 ng/mL for toxin A and 0.16 ng/mL for toxin B.
7
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/7/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" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, featuring a staff with three intertwined snakes and a pair of wings at the top.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Charles Pennington, MS Director of Product Development Techlab, Inc. 2001 Kraft Drive Blacksburg, VA 24060
Re: K082499
K062499
Trade/Device Name: C. DIFF QUIK CHEK COMPLETE™ Regulation Number: 21 CFR 866.2660 Regulation Name: Microorganism differentiation and identification device Regulatory Class: I Product Code: LLH Dated: November 5, 2008 Received: February 26, 2009
MAR 2 6 2009
Dear Mr. Pennington:
We have reviewed your Section 510(k) premarket notification of intent to market the we have formed your botton a 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 marketou in interblate ouments, 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 wint also provide of 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, provisions facturing 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 (1 will in the 20 base 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 i coderal agencies: "Found 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).
8
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 advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at 240-276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Sally attaym
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
9
C. DIFF QUIK CHEK COMPLETE™ 510(k)
INDICATIONS FOR USE 2.
510(k) Number (if known):
C. DIFF QUIK CHEK COMPLETE™ Device Name:
Indications For Use:
The C. DIFF QUIK CHEK COMPLETE™ test is a rapid membrane enzyme immunoassay for the simultaneous detection of Clostridium difficile glutamate dehydrogenase antigen and toxins A and B in a single reaction well. The test detects C. difficile antigen, glutamate dehydrogenase, as a screen for the presence of C. difficile and confirms the presence of toxigenic C. difficile by detecting toxins A and B in fecal specimens from persons suspected of having C. difficile disease. The test is to be used as an aid in the diagnosis of C. difficile disease. As with other C. difficile tests, results should be considered in conjunction with the patient history.
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)
Fuedde leole
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K082499
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