(165 days)
Instant-View™ Fecal Occult Blood Rapid Test, K021423
Not Found
No
The device description and performance studies indicate a simple immunochromatography test with visual interpretation, with no mention of AI/ML or related concepts.
No.
The device is an in-vitro diagnostic test used for qualitative detection of fecal occult blood, which aids in determining gastrointestinal bleeding. It does not provide any therapy or treatment.
Yes
The device is designed for the "qualitative detection of fecal occult blood," which is used to "determine gastrointestinal bleeding" and "screening for colorectal cancer or gastrointestinal bleeding from any source." These functions indicate the device is used to detect the presence of a condition or disease, fitting the definition of a diagnostic device.
No
The device is a physical, in-vitro diagnostic test kit that relies on immunochromatography and visual interpretation, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use / Indications for Use: The description explicitly states it is an "immunochromatography based in-vitro test designed for qualitative detection of fecal occult blood". The term "in-vitro" is a direct indicator of an IVD. It also describes its use in analyzing a biological sample (fecal occult blood) to provide information about a patient's health (gastrointestinal bleeding).
- Device Description: The description details how the test works by analyzing a specimen (stool) outside of the body using chemical reactions (antibody complex formation, migration on a membrane). This process is characteristic of an in-vitro diagnostic test.
- Care Setting: The intended users are "laboratories or physicians offices," which are common settings for performing IVD tests.
N/A
Intended Use / Indications for Use
The OcculTech Fecal Occult Blood Rapid test is a card type rapid test and an immunochromatography-based in-vitro test designed for qualitative detection of fecal occult blood that can be performed in laboratories or physicians offices. It is useful in determining gastrointestinal bleeding found in a number of gastrointestinal disorders (e.g., diverticulitis, colitis, polyps and colorectal cancer). This device is recommended for use in routine physical examinations, when hospital patients are first admitted, hospital monitoring for bleeding in patients, and screening for colorectal cancer or gastrointestinal bleeding from any source.
Product codes
KHE
Device Description
The OcculTech Fecal Occult Blood Rapid Test is a colloidal gold enhanced immunoassay for the detection of hemoglobin in human stool. During the assay the specimen stool are absorbed into the sample pad and migrate upwards chromatographically on the membrane by capillary action. The specimen stool - extraction containing hemoglobin forms antibody complex with monoclonal antihemoglobin IgG gold colloid conjugate in the conjugate pad. The mixure migrates to nitrocellulose membrane in the test region where other immobilized monoclonal antihemoglobin IgG is present, and then forms a colored sandwich binding (ant-hemoglobin IgG gold colloid-hemoglobin-anti hemoglobin IgG). The OcculTech Fecal Occult Blood Rapid Test is one step test based on the immunochromatography. The test results are visually determined without using any special instrument. It is a simple operation and a number of specimen can be treated in minimal time.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Gastrointestinal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
laboratories or physicians offices
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)
Sensitivity and Prozone effect:
In study of 40 stool extraction samples, the OcculTech Fecal Occult Blood Rapid test can detect the human hemoglobin(hHb) at the level close to or higher than 50ng/mL in extraction buffer. No interference from prozone effect was observed when the hHb level reached up to 2000ng hHb/mL, which is equivalent to 2mg hHb/g feces.
Human hemoglobin level performed this study are as following : 0, 37.5, 50, 62.5, 2000ng hHb/mL.
Specificity (cross-reactivity)
In study of cross-reactivity for hemoglobin from other species, both Devices (Occul Tech, Instant-View™) indicated negative test results when tested with the Hb of other species when hHb was absent(Negative solution) and positive test results in all cases when hHb was present(Positive solution, 50ng/mL). This test results showed that OcculTech Fecal Occult Blood Rapid Test agrees 100% with predicate device.
Hemoglobin of other species used this test are as following : Horse hemoglobin, Rabbit hemoglobin, Fish hemoglobin, Beef hemoglobin, Chicken Hemoglobin, Goat hemoglobin, Pig hemoglobin, Sheep hemoglobin.
Specificity (Interference)
In study of Interference substances Both Devices (OcculTech, Instant-View™) indicated negative test results when tested with the substances when hHb was absent (Negative solution)and positive test results in all cases when hHb was present(Positive solution, 50ng/mL). Each test was performed as duplicates. This test results showed that OcculTech Fecal Occult Blood Rapid Test agrees 100% agreed with predicate device.
Interference substances tested are as following : Horseradish perosidase, Red radish, Raw turnip, Cauliflower, Broccoli, Parsnip, Cantaloupe, Ascorbic acid, Iron, Human Serum Albumin.
Reproducibility and Repeatability
In study of reproducibility and repeatability, the results obtained from the tests performed by the three professionals with diverse education backgrounds and work experiences agreed 98% with expected results(average). The results obtained from the Reference Laboratory agreed 99% with expected results. And OcculTech Fecal Occult Blood Rapid Test agreed 99% with Instant-View™ Fecal Occult Blood Rapid Test.
Stability
- For specimen: The test result showed that specimen can store up to 6 months at 4℃ and 24 months at -20 ℃.
- For test strip after opening: The test result showed that test strip after opening can store up to 28 days at room temperature.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity: 50ng/mL (detection level)
Specificity: 100% with predicate device (cross-reactivity and interference studies)
Reproducibility: 98% (agreement with expected results by professionals), 99% (agreement with Reference Laboratory)
Repeatability: 98% (agreement with expected results by professionals), 99% (agreement with Reference Laboratory), 99% (agreement with predicate device)
Predicate Device(s)
Instant-View™ Fecal Occult Blood Rapid Test, 510(k) number K021423
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 864.6550 Occult blood test.
(a)
Identification. An occult blood test is a device used to detect occult blood in urine or feces. (Occult blood is blood present in such small quantities that it can be detected only by chemical tests of suspected material, or by microscopic or spectroscopic examination.)(b)
Classification. Class II (special controls). A control intended for use with an occult blood test is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
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SEP 1 8 2006
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:
User Fee Payment ID. No.: MD6025264-956733
Submitter :
YD Diagnostics 2F, Keukdong A Building, 228-8, Chamsil-Dong Songpa-Gu, Seoul, Korea Tel.82-31-333-3827, Fax.82-31-339-0176 Contact : Young Nam Park Date Prepared : March 5, 2004
Contact Person :
Dusic Kwak, Esq. Kwak & Associates, P. C. 4304 Evergreen Lane, Suite 101 Annandale, Virginia 22003 Tel: 703-658-6347 Fax: 703-658-9807 e-mail: annandalelawfirm@yahoo.com
Device name :
OcculTech Fecal Occult Blood Rapid Test Common or usual name : Fecal Occult Blood (FOB) Test
Predicate Device :
Instant-View™ Fecal Occult Blood Rapid Test, 510(k) number K021423
Device Description:
The OcculTech Fecal Occult Blood Rapid Test is a colloidal gold enhanced immunoassay for the detection of hemoglobin in human stool. During the assay the specimen stool are absorbed into the sample pad and migrate upwards chromatographically on the membrane by capillary action. The specimen stool
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- extraction containing hemoglobin forms antibody complex with monoclonal antihemoglobin IgG gold colloid conjugate in the conjugate pad. The mixure migrates to nitrocellulose membrane in the test region where other immobilized monoclonal antihemoglobin IgG is present, and then forms a colored sandwich binding (ant-hemoglobin IgG gold colloid-hemoglobin-anti hemoglobin IgG). The OcculTech Fecal Occult Blood Rapid Test is one step test based on the immunochromatography. The test results are visually determined without using any special instrument. It is a
simple operation and a number of specimen can be treated in minimal time.
The following types of tests for fecal occult blood (FOB) testing are commercially available Guaiac, Hemoporphyrin and immunochemical. The guaiac test is widely available but lacks in accuracy. The hemoporphyrin test can cause false positive result for patients who have gastric or duodenal ulcers. The immunochemical FOB rapid test is much more sensitive and has been designed to specifically detect low levels of human fecal occult blood.
Intended Use:
The OcculTech Fecal Occult Blood Rapid test is a card type rapid test and an immunochromatography-based in-vitro test designed for qualitative detection of fecal occult blood that can be performed in laboratories or physicians offices. It is useful in determining gastrointestinal bleeding found in a number of gastrointestinal disorders (e.g., diverticulitis, colitis, polyps and colorectal cancer). This device is recommended for use in routine physical examinations, when hospital patients are first admitted, hospital monitoring for bleeding in patients, and screening for colorectal cancer or gastrointestinal bleeding from any source.
Statement of how the technology characteristics of the device Compare to the predicate device:
The technology characteristics of the OcculTech Fecal Occult Blood Rapid Test is same as the legally marked predicate device (Instant-View™ Fecal Occult Blood Rapid Test).
Sensitivity and Prozone effect :
In study of 40 stool extraction samples, the OcculTech Fecal Occult Blood Rapid test can detect the human hemoglobin(hHb) at the level close to or higher than 50ng/mL in extraction buffer. No interference from prozone effect was observed when the hHb level reached up to 2000ng hHb/mL, which is equivalent to 2mg hHb/g feces.
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Human hemoglobin level performed this study are as following : 0, 37.5, 50, 62.5, 2000ng hHb/mL.
Specificity (cross-reactivity)
In study of cross-reactivity for hemoglobin from other species, both Devices (Occul Tech, Instant-View™) indicated negative test results when tested with the Hb of other species when hHb was absent(Negative solution) and positive test results in all cases when hHb was present(Positive solution, 50ng/mL).
This test results showed that OcculTech Fecal Occult Blood Rapid Test agrees 100% with predicate device.
Hemoglobin of other species used this test are as following : Horse hemoglobin, Rabbit hemoglobin, Fish hemoglobin, Beef hemoglobin, Chicken Hemoglobin, Goat hemoglobin, Pig hemoglobin, Sheep hemoglobin.
Specificity (Interference)
In study of Interference substances Both Devices (OcculTech, Instant-View™) indicated negative test results when tested with the substances when hHb was absent (Negative solution)and positive test results in all cases when hHb was present(Positive solution, 50ng/mL). Each test was performed as duplicates.
This test results showed that OcculTech Fecal Occult Blood Rapid Test agrees 100% agreed with predicate device.
Interference substances tested are as following :
Horseradish perosidase, Red radish, Raw turnip, Cauliflower, Broccoli, Parsnip, Cantaloupe, Ascorbic acid, Iron, Human Serum Albumin.
Reproducibility and Repeatability
In study of reproducibility and repeatability, the results obtained from the tests performed by the three professionals with diverse education backgrounds and work experiences agreed 98% with expected results(average). The results obtained from the Reference Laboratory agreed 99% with expected results. And OcculTech Fecal Occult Blood Rapid Test agreed 99% with Instant-View™ Fecal Occult Blood Rapid Test.
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Stability
- For specimen
The test result showed that specimen can store up to 6 months at 4℃ and 24 months at -20 ℃.
- For test strip after opening
The test result showed that test strip after opening can store up to 28 days at room temperature.
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Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
SEP 1 8 2006
YD Diagnostics Corporation c/o Kwak & Associates 4304 Evergreen Lane Suite 101 Annandale, VA 22003 ATTN: Dusic Kwak
Re: K060953
Trade/Device Name: OcculTech Fecal Occult Blood Rapid Test Regulation Number: 21 CFR 864.6550 Regulation Name: Occult blood test Regulatory Class: II Product Code: KHE Dated: April 4, 2006 Received: April 6, 2006
Dear Mr. Kwak:
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). This letter
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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 (240) 276-0484. 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 (240) 276-3150, or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Robert Zseckaf
Robert L. Becker, Jr., MD, PhD Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name:
OcculTech Fecal Occult Blood Rapid Test
Indications For Use:
The OcculTech Occult Blood Rapid Test is a card type rapid test and an immunochromatography based in-vitro test designed for qualitative detection of fecal occult blood that can be performed in laboratories or physicians offices. It is useful in determining gastrointestinal bleeding found in a number of gastrointestinal disorders (e.g. diverticulitis, colitis, polyps and colorectal cancer). This device is recommended for use in routine physical examinations, when hospital patients are first admitted, hospital monitoring for bleeding in patients, and screening for colorectal cancer or gastrointestinal bleeding from any source.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 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)
Robert Becker
Division Sign-Off
Office of In Vitro Diagnostic
Device Evaluation and Safety
510(k) K060953
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