(23 days)
Not Found
No
The device description details a qualitative immunoassay based on antibody binding and color change, with no mention of computational analysis, algorithms, or learning processes.
No
This device is a diagnostic tool designed for the rapid and qualitative determination of Human Blood in fecal samples to detect gastrointestinal bleeding. It does not provide treatment or therapy.
Yes
The device rapidly and qualitatively determines human blood in fecal samples, which is used for screening for colorectal cancer or gastrointestinal (GI) bleeding due to various GI disorders. This direct medical assessment indicates it is a diagnostic device.
No
The device description clearly outlines a physical test kit involving a sampler, tube, buffer, and test cassette detection system, indicating it is a hardware-based immunoassay, not software only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "rapid and qualitative determination of Human Blood fecal samples." This is a classic example of an in vitro diagnostic test, as it analyzes a biological sample (feces) outside of the body to provide information about a patient's health status (presence of blood).
- Device Description: The description details a "qualitative, sandwich dye conjugate immunoassay" that uses antibodies to detect a component of human hemoglobin in fecal specimens. This is a common methodology for IVD tests.
- Sample Type: The device analyzes "fecal samples," which are biological specimens.
- Purpose: The test is used to aid in the diagnosis of gastrointestinal bleeding and for screening for colorectal cancer or GI bleeding. These are diagnostic purposes.
- Intended User: It is intended for "professional and laboratory use only," which is typical for many IVD devices.
The information provided clearly aligns with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Hema-Screen TM Specific Gold is for the rapid and qualitative determination of Human Blood fecal samples. It is intended for professional and laboratory use only. It is also useful for determining gastrointestinal bleeding due to a number of gastrointestinal (GI) disorders such as diverticulitis, colitis, polyps and colorectal cancer. This test is recommended for use in routine physical examines, hospital monitoring of bleeding in patients, and for screening for colorectal cancer or gastrointestinal (GI) bleeding from any source.
The hema-screen™ SPECIFIC Gold is for the rapid and qualitative determination of Human Blood fecal samples. It is intended for professional and laboratory use only. It is also useful for determining gastrointestinal bleeding due to a number of gastrointestinal (GI) disorders such as diverticulitis, colitis, polyps and colorectal cancer. This test is recommended for use in routine physical examines, hospital monitoring of bleeding in patients, and for screening for colorectal cancer or gastrointestinal (GI) bleeding from any source.
Product codes (comma separated list FDA assigned to the subject device)
KHE
Device Description
hema-screen™ SPECIFIC Gold is a qualitative, sandwich dye conjugate immunoassay that employs a unique combination of monoclonal antibodies to selectively identify the globin component of human hemoglobin in fecal specimens with a high degree of analytical sensitivity. Two samples of feces, collected using the unique DEVEL-A-TAB Sampler, are dispersed in a single tube containing a known volume of buffer. The unique design of the Sampler ensures that a controlled amount of feces is added to the specimen preparation tube. Then, the feces in buffer is transferred to the test cassette detection system using the tube itself as the delivery system. In less than five minutes, unusually elevated concentrations of human hemoglobin in feces can be detected and positive results for abnormal concentrations of hemoglobin can be seen in the test cassette detection system as early as two or three minutes after application of specimen. As the feces in buffer specimen flows up through the absorbent device, the labeled antibody-dye conjugate binds to the globin of hemoglobin in the specimen forming an antibody-antigen complex. This complex binds to anti-globin antibody in the positive test reaction zone and produces a pink-rose color band. In the absence of hemoglobin, there is no line in the test reaction zone. The pink-rose color bands in the control reaction zone demonstrate that the reagents and devices are functioning correctly. In the extremely rare event of operator or test cassette failure, sufficient specimen is available in the tube to repeat the procedure with another test cassette.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
fecal samples
Indicated Patient Age Range
Not Found
Intended User / Care Setting
professional and laboratory use only.
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)
Summary of Patient Fecal Sample Testing: Each of the three lots of hema-screen™ SPECIFIC Gold were 100% agreement with predicate, 100% positive percent agreement with the predicate and 100% negative percent with the predicate. The testing results meet the acceptance criteria (greater than 98% total, PPA, NPA) for the study.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
100% agreement with predicate, 100% positive percent agreement with the predicate and 100% negative percent with the predicate.
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.
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
§ 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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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling a stylized caduceus or a series of human profiles, rendered in black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 14, 2017
Immunostics, Inc. Elizabeth Galella Manager Regulatory Affairs 1750 Brielle Avenue Suite A5 Ocean, New Jersey 07712
Re: K171484
Trade/Device Name: hema-screen™ SPECIFIC Gold Regulation Number: 21 CFR 864.6550 Regulation Name: Occult blood test Regulatory Class: Class II Product Code: KHE Dated: May 19, 2017 Received: May 22, 2017
Dear Ms. Galella:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
1
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely.
Leonthena R. Carrington -S
Lea R. Carrington, MS, MBA, MT(ASCP) Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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510(k)No.: unknown
Indications for Use Statement
| Device Name: | hema-screen TM SPECIFIC Gold |
|---|---|
| Indications For Use: | The Hema-Screen TM Specific Gold is for the rapid and qualitative determination of Human Blood fecal samples. It is intended for professional and laboratory use only. It is also useful for determining gastrointestinal bleeding due to a number of gastrointestinal (GI) disorders such as diverticulitis, colitis, polyps and colorectal cancer. This test is recommended for use in routine physical examines, hospital monitoring of bleeding in patients, and for screening for colorectal cancer or gastrointestinal (GI) bleeding from any source. |
| Prescription Use | XX AND/OR Over the Counter Use _______ |
| (21 CFR Part 801 Subpart D) (21 CFR Part 801 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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3
Duality Microbiological, Serological and Immunological Reagents
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SPECIAL 510(k) SUMMARY
hema-screen™ SPECIFIC Gold
This summary of the 510(k) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR, Section 807.92.
Date Summary Prepared: May 19, 2017
Regulatory Correspondent
Immunostics, Inc. 1750 Brielle Ave, Suite A5 Ocean, NJ 07712 USA Phone: (732) 918-0770 Fax: (732) 918-0618 Contact: Elizabeth Galella Email: egalella@immunostics.com Website: www.immunostics.com Establishment registration Number: 2244821
Device Information
Trade Name: hema-screen™ SPECIFIC Gold Common Name: Fecal Immunochemical Test
Classification Name: Reagent, Occult Blood Product Code: KHE Regulation: 21 CFR § 864.6550
Predicate Device: hema-screen™ SPECIFIC Predicate 510(k) Number: K060463
Device Description: Subject Device hema-screen™ SPECIFIC Gold
Intended Use/Indication for Use:
The hema-screen™ SPECIFIC Gold is for the rapid and qualitative determination of Human Blood fecal samples. It is intended for professional and laboratory use only. It is also useful for determining gastrointestinal bleeding due to a number of gastrointestinal (GI) disorders such as diverticulitis, colitis, polyps and colorectal cancer. This test is recommended for use in routine physical examines, hospital monitoring of bleeding in patients, and for screening for colorectal cancer or gastrointestinal (GI) bleeding from any source.
Image /page/3/Picture/15 description: The image shows the logo for "Immunostics, inc.". The logo features a stylized starburst to the left of the text. The text is in a serif font and is gray in color. The logo is simple and clean, and it is likely used to represent the company's brand.
1750 Brielle Ave. · A5 · Ocean, New Jersey · 07712 (800) 722-7505 · Fax: (732) 918-0618 www.lmmunostics.com
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Quality Microbiological, Serological and Immunological Reagents
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SPECIAL 510(k) SUMMARY
Principles of Test
hema-screen™ SPECIFIC Gold is a qualitative, sandwich dye conjugate immunoassay that employs a unique combination of monoclonal antibodies to selectively identify the globin component of human hemoglobin in fecal specimens with a high degree of analytical sensitivity. Two samples of feces, collected using the unique DEVEL-A-TAB Sampler, are dispersed in a single tube containing a known volume of buffer. The unique design of the Sampler ensures that a controlled amount of feces is added to the specimen preparation tube. Then, the feces in buffer is transferred to the test cassette detection system using the tube itself as the delivery system. In less than five minutes, unusually elevated concentrations of human hemoglobin in feces can be detected and positive results for abnormal concentrations of hemoglobin can be seen in the test cassette detection system as early as two or three minutes after application of specimen. As the feces in buffer specimen flows up through the absorbent device, the labeled antibody-dye conjugate binds to the globin of hemoglobin in the specimen forming an antibody-antigen complex. This complex binds to anti-globin antibody in the positive test reaction zone and produces a pink-rose color band. In the absence of hemoglobin, there is no line in the test reaction zone. The pink-rose color bands in the control reaction zone demonstrate that the reagents and devices are functioning correctly. In the extremely rare event of operator or test cassette failure, sufficient specimen is available in the tube to repeat the procedure with another test cassette.
Technological Characteristics:
The fundamental scientific technology of the subject device has not changed. The design, material and chemical composition of the lateral flow membrane has not changed. There is no change in analytical sensitivity of the subject device.
The change is for new housing for the lateral flow membrane.
Summary of Patient Fecal Sample Testing:
Each of the three lots of hema-screen™ SPECIFIC Gold were 100% agreement with predicate, 100% positive percent agreement with the predicate and 100% negative percent with the predicate. The testing results meet the acceptance criteria (greater than 98% total, PPA, NPA) for the study.
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SPECIAL 510(k) SUMMARY
Substantial Equivalence
Similarities
| Item | Subject Device K171484
hema-screen™ SPECIFIC Gold | Predicate Device K060463
hema-screen™ SPECIFIC |
|---------------------------------------------|------------------------------------------------------|---------------------------------------------------|
| Intended Use/Indications for Use | Same | Same |
| Operating Principle (Principles of
Test) | Same | Same |
| Technological Characteristics | Same | Same |
| Shelf Life | Same | Same |
| Performance Characteristics | Same | Same |
Differences
| Item | Subject Device K171484
hema-screen™ SPECIFIC Gold hema-screen™ SPECIFIC | Predicate Device K060463 |
|-------------------|------------------------------------------------------------------------------|----------------------------|
| Design of Housing | Slimmer housing design | Rectangular housing design |
Conclusion Drawn:
The subject, hema-screen™ SPECIFIC Gold, and predicate, hema-screen™ SPECIFIC, have the same Intended Use/Indications for Use Statement, Principles for Test, Technological Characteristics, Shelf Life and Performance Characteristics.
The only difference between the subject, hema-screen™ SPECIFIC Gold, and predicate, hemascreen™ SPECIFIC is the housing. The lateral flow membrane is the same. The housing change between the subject hema-screen™ SPECIFIC Gold and the predicate hema-screen™ SPECIFIC raises no new issues of safety and effectiveness.
The subject, hema-screen™ SPECIFIC Gold, is as safe, as effective and as performs as well as the predicate, hema-screen™ SPECIFIC.
The subject, hema-screen™ SPECIFIC Gold, is substantially equivalent to the predicate, hemascreen™ SPECIFIC.
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