(165 days)
K931241/A1
Not Found
No
The device description details a standard immunochromatographic assay based on antibody binding and visual interpretation of lines. There is no mention of computational analysis, algorithms, or learning processes.
No.
The device is an in vitro diagnostic test for detecting a marker of intestinal inflammation, not for providing therapy or treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states "FOR IN VITRO DIAGNOSTIC USE." Additionally, the device is described as detecting a marker (fecal lactoferrin) for intestinal inflammation, and a positive result "warrants additional testing," which are characteristics of a diagnostic device.
No
The device description clearly outlines a physical immunochromatographic test kit with antibodies immobilized on a membrane, colloidal gold particles, and a cassette. This is a hardware-based in vitro diagnostic device, 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 clearly states: "FOR IN VITRO DIAGNOSTIC USE."
- Nature of the Test: The device performs a test on a biological sample (fecal specimen) outside of the body ("in vitro") to detect a marker (lactoferrin) that indicates a medical condition (intestinal inflammation). This is the definition of an in vitro diagnostic test.
- Regulatory Context: The inclusion of a "Predicate Device(s)" section with a K number (K931241/A1) indicates that this device is being compared to a previously cleared medical device, which is a standard part of the regulatory process for IVDs.
Therefore, based on the provided information, the LEUKO EZ VUE™ test is an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The LEUKO EZ VUE™ test is an immunochromatographic test for the qualitative detection of elevated levels of fecal lactoferrin, a marker for fecal leukocytes and an indicator of intestinal inflammation. The LEUKO EZ VUE™ test detects lactoferrin in liquid, semi-solid, and solid fecal specimens. A positive test result indicates an increased level of fecal lactoferrin and warrants additional testing. FOR IN VITRO DIAGNOSTIC USE.
Product codes (comma separated list FDA assigned to the subject device)
DEG
Device Description
The LEUKO EZ VUE™ test is a 10 minute immunochromatographic device for the detection of elevated levels of lactoferrin, a marker for fecal leukocytes and an indicator of intestinal inflammation. The test utilizes the same polyclonal antibodies against human lactoferrin as our previously cleared LEUKO-TEST assay. The polyclonal antibodies to human lactoferrin are immobilized on nitrocellulose and the conjugate consists of the same antibodies linked to colloidal gold particles. The membrane cassette contains two stripes of immobilized antibodies. One stripe contains anti-lactoferrin antibodies. The other, representing a control stripe, contains anti-IgG antibodies. The diluted sample and gold conjugate migrate by capillary action when the sample is added to the well. If elevated lactoferrin is present in the sample, gold conjugate-lactoferrin complexes form and are captured by the immobilized anti-lactoferrin antibodies in the stripe. The lactoferrin-conjugate-antibody complexes appear as a single red line in the test portion of the Results window. In the control stripe, conjugate binds to the immobilized anti-IgG antibodies, demonstrating correct migration of the sample and conjugate along the membrane. The conjugate-anti-IgG antibodies appear as a single red line in the control portion of the Results window.
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)
TECHLAB®, Inc. has evaluated the LEUKO EZ VUE™ test, which is a new lateral flow test for the detection of elevated levels of fecal lactoferrin, a marker for fecal leukocytes and an indicator of intestinal inflammation. The purpose of this study was to evaluate the performance of the LEUKO EZ VUE™ test as an in vitro diagnostic aid to help identify patients with inflammatory diarrhea.
When comparing the LEUKO EZ VUE™ to the LEUKO-TEST in clinical studies, the LEUKO EZ VUE™ test had positive, negative, and overall agreements of 93%, 80%, and 83%, respectively. Individual results are shown in the table below.
LEUKO EZ VUE™ vs LEUKO-TEST (N=375)
LEUKO-TEST Positive: 105
LEUKO-TEST Negative: 270
LEUKO EZ VUE™ Positive: 153
LEUKO EZ VUE™ Negative: 222
Additional studies including intra- and inter-assay variation showed the assay to be reproducible with all positive samples remaining positive and all negative samples remaining negative upon additional testing. Serial dilutions of highly purified human lactoferrin demonstrated acceptable assay sensitivity with a minimum detection limit ≥ 128 ng/mL.
The LEUKO EZ VUE™ test is simple to perform, requiring minimal training. The procedure includes a single specimen dilution, the transfer of 4 drops of diluted specimen to the sample well of the membrane cassette and a visual reading following a 10-minute incubation.
Based on these findings, we believe the LEUKO EZ VUE™ test is substantially equivalent to the LEUKO TEST now used to evaluate patients for elevated fecal leukocytes as an indicator of intestinal inflammation. Further, our results demonstrate that the LEUKO EZ VUE™ test is suitable as an in vitro diagnostic aid to help identify patients with inflammatory diarrhea.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Percent Positive Agreement: 93% (95% Confidence Intervals: 86 – 97%)
Percent Negative Agreement: 80% (95% Confidence Intervals: 74 – 84%)
Overall Percent Agreement: 83% (95% Confidence Intervals: 80 – 86%)
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.
K931241/A1
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
§ 866.5570 Lactoferrin immunological test system.
(a)
Identification. A lactoferrin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the lactoferrin (an iron-binding protein with the ability to inhibit the growth of bacteria) in serum, breast milk, other body fluids, and tissues. Measurement of lactoferrin may aid in the diagnosis of an inherited deficiency of this protein.(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
LEUKO EZ VUE™ 510(k)
Image /page/0/Picture/1 description: The image shows a handwritten string of characters. The string appears to be a combination of letters and numbers. The string reads 'K071712'.
7.0 510(k) SUMMARY OF THE LEUKO EZ VUE™
| Contact Information | Charles Pennington | |
|---|---|---|
| Director of Product Development | ||
| TECHLAB®, Inc. | DEC 0 4 2007 | |
| 2001 Kraft Drive | ||
| Corporate Research Center | ||
| Blacksburg, VA 24060-6358 | ||
| Phone: 540-953-1664 | ||
| FAX: 540-953-1665 | ||
| Email: cpennington@techlab.com | ||
| Date Prepared | November 19, 2007 | |
| Product and Trade Name TECHLAB® LEUKO EZ VUE™ | ||
| Classification | Class I, 21 CFR 866.5570 |
Predicate Devices
- TECHLAB® LEUKO-TEST (K931241/A1). The LEUKO-TEST is a latex . agglutination test for detecting elevated levels of fecal lactoferrin as a marker of fecal leukocytes and intestinal inflammation. The test is simple to use and rapid.
- Methylene Blue stain and Gram stain along with microscopic observation. . This assay is exempt from 510(k), but serves as a predicate device because it was marketed prior to 1976 and continues to be legally marketed today. The procedure involves the staining of fecal smears from patients with diarrhea followed by microscopic observation for the presence of leukocytes. The analysis must be performed by qualified individuals who have experience in the microscopic identification of leukocytes in fecal specimens. In addition, the test must be performed as soon as possible after collection of the specimen because of the instability of fecal leukocytes.
Intended Use
The LEUKO EZ VUE™ test is an immunochromatographic test for the qualitative detection of elevated levels of fecal lactoferrin, a marker for fecal leukocytes and an indicator of intestinal inflammation. The LEUKO EZ VUE™ test detects lactoferrin in liquid, semi-solid, and solid fecal specimens. A positive test result indicates an increased level of fecal lactoferrin and warrants additional testing. FOR IN VITRO DIAGNOSTIC USE.
Device Description
The LEUKO EZ VUE™ test is a 10 minute immunochromatographic device for the detection of elevated levels of lactoferrin, a marker for fecal leukocytes and an indicator
1
of intestinal inflammation. The test utilizes the same polyclonal antibodies against human lactoferrin as our previously cleared LEUKO-TEST assay. The polyclonal antibodies to human lactoferrin are immobilized on nitrocellulose and the conjugate consists of the same antibodies linked to colloidal gold particles. The membrane cassette contains two stripes of immobilized antibodies. One stripe contains anti-lactoferrin antibodies. The other, representing a control stripe, contains anti-IgG antibodies. The diluted sample and gold conjugate migrate by capillary action when the sample is added to the well. If elevated lactoferrin is present in the sample, gold conjugate-lactoferrin complexes form and are captured by the immobilized anti-lactoferrin antibodies in the stripe. The lactoferrin-conjugate-antibody complexes appear as a single red line in the test portion of the Results window. In the control stripe, conjugate binds to the immobilized anti-IgG antibodies, demonstrating correct migration of the sample and conjugate along the membrane. The conjugate-anti-IgG antibodies appear as a single red line in the control portion of the Results window.
| Test | Description | Format | Turn-around time | Limitations |
|---|---|---|---|---|
| LEUKO EZ | ||||
| VUETM | Intended for | |||
| determining elevated | ||||
| levels of fecal | ||||
| lactoferrin as a | ||||
| marker for fecal | ||||
| leukocytes and an | ||||
| indicator of intestinal | ||||
| inflammation. A | ||||
| positive test result | ||||
| indicates an | ||||
| increased level of | ||||
| fecal lactoferrin and | ||||
| warrants additional | ||||
| testing. | Lateral flow | 10 | ||
| minutes | Rapid test format | |||
| as the LEUKO- | ||||
| TEST but | ||||
| overcomes | ||||
| inherent problems | ||||
| of latex | ||||
| agglutination, | ||||
| including | ||||
| difficult-to-read | ||||
| reactions | ||||
| LEUKO-TEST | ||||
| (K931241/A1) | Intended for | |||
| determining | ||||
| elevated levels of | ||||
| fecal lactoferrin | ||||
| as a marker for | ||||
| fecal leukocytes | ||||
| and an indicator | ||||
| of intestinal | ||||
| inflammation | Latex | |||
| agglutination | 3 minutes | Latex | ||
| agglutination may | ||||
| give difficult-to- | ||||
| read reactions as | ||||
| well as other | ||||
| inherent problems | ||||
| Methylene Blue | ||||
| and Gram stain | ||||
| for observing | ||||
| fecal leukocytes | Intended for | |||
| detecting fecal | ||||
| leukocytes in | ||||
| fecal smears | Staining of fecal | |||
| smears and | ||||
| examination for | ||||
| leukocytes | 30 to 60 | |||
| minutes | Requires | |||
| experience and test | ||||
| must be performed | ||||
| within minutes of | ||||
| collecting the fecal | ||||
| specimen due to | ||||
| instability of | ||||
| leukocytes |
Comparative information of equivalent devices
2
Summary of Performance Data
TECHLAB®, Inc. has evaluated the LEUKO EZ VUE™ test, which is a new lateral flow test for the detection of elevated levels of fecal lactoferrin, a marker for fecal leukocytes and an indicator of intestinal inflammation. The purpose of this study was to evaluate the performance of the LEUKO EZ VUE™ test as an in vitro diagnostic aid to help identify patients with inflammatory diarrhea.
When comparing the LEUKO EZ VUE™ to the LEUKO-TEST in clinical studies, the LEUKO EZ VUE™ test had positive, negative, and overall agreements of 93%, 80%, and 83%, respectively. Individual results are shown in the table below.
| LEUKO EZ VUETM vs
LEUKO-TEST
(N=375) | LEUKO-TEST
Positive | LEUKO-TEST
Negative | Total |
|----------------------------------------------------------|-------------------------------|-------------------------------|-------|
| LEUKO EZ VUETM
Positive | 98 | 55 | 153 |
| LEUKO EZ VUETM
Negative | 7 | 215 | 222 |
| Total | 105 | 270 | 375 |
| 95% Confidence Intervals | ||
|---|---|---|
| Percent Positive Agreement | 93% | 86 – 97% |
| Percent Negative Agreement | 80% | 74 – 84% |
| Overall Percent Agreement | 83% | 80 – 86% |
Additional studies including intra- and inter-assay variation showed the assay to be reproducible with all positive samples remaining positive and all negative samples remaining negative upon additional testing. Serial dilutions of highly purified human lactoferrin demonstrated acceptable assay sensitivity with a minimum detection limit ≥ 128 ng/mL.
The LEUKO EZ VUE™ test is simple to perform, requiring minimal training. The procedure includes a single specimen dilution, the transfer of 4 drops of diluted specimen to the sample well of the membrane cassette and a visual reading following a 10-minute incubation.
Based on these findings, we believe the LEUKO EZ VUE™ test is substantially equivalent to the LEUKO TEST now used to evaluate patients for elevated fecal leukocytes as an indicator of intestinal inflammation. Further, our results demonstrate that the LEUKO EZ VUE™ test is suitable as an in vitro diagnostic aid to help identify patients with inflammatory diarrhea.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a stylized depiction of an eagle or bird in flight, composed of three curved lines that suggest feathers or wings. The bird is positioned within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" is arranged around the upper half of the circle.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
DEC 0 4 2007
TECHLAB Inc. c/o Mr. Charles Pennington Director of Product Development 2001 Kraft Drive Blacksburg, VA 24060-6358
Re: K071712
Trade/Device Name: TECHLAB® LEUKO EZ VUETM Regulation Number: 21 CFR 866.5570 Regulation Name: Lactoferrin, antigen, antiserum, control Regulatory Class: Class I Product Code: DEG Dated: November 19, 2007 Received: November 21, 2007
Dear Mr. Pennington:
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 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 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The
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Page 2 –
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 (240) 276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
Robert Becker
Robert L. Becker, Jr., M.D., Ph Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
5
2.0 STATEMENT OF INTENDED USE
Indications for Use
510(k) Number (if known): KO71712
Device Name: LEUKO EZ VUE™
The LEUKO EZ VUE™ test is an immunochromatographic test for the qualitative detection of elevated levels of fecal lactoferrin, a marker for fecal leukocytes and an indicator of intestinal inflammation. The LEUKO EZ VUE™ test detects lactoferrin in liquid, semi-solid, and solid fecal specimens. A positive test result indicates an increased level of fecal lactoferrin and warrants additional testing. FOR IN VITRO DIAGNOSTIC USE.
Prescription Use X (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)
m Chan
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K071712