(84 days)
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No
The device description and performance studies indicate a traditional immunoassay-based test for detecting human hemoglobin. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
No
The device is a diagnostic tool used for screening purposes to detect GI bleeding, which can indicate various conditions, but it does not directly treat or alleviate a medical condition.
Yes
Explanation: The device is intended for the "rapid qualitative detection of human hemoglobin in fecal samples" and is used as a "screening tool for detecting lower gastrointestinal (GI) bleeding that may be related to iron deficiency anemia, peptic ulcer, ulcerative colitis, polyp and colorectal cancer." This description clearly indicates its use in identifying and characterizing a disease or condition, which is the definition of a diagnostic device.
No
The device description clearly states it is a "rapid test" that "uses monoclonal antibodies" and a "double antibody sandwich assay," indicating it is a physical, in-vitro diagnostic device, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "rapid qualitative detection of human hemoglobin in fecal samples." This involves testing a sample taken from the body (fecal matter) outside of the body (in vitro) to provide diagnostic information (detection of occult blood).
- Device Description: The description details a "rapid test intended for the qualitative detection of low levels Fecal Occult Blood" using antibodies. This is a common characteristic of in vitro diagnostic tests.
- Sample Type: The test uses "fecal samples," which are biological specimens collected from the body for analysis.
- Purpose: The test is used as a "screening tool for detecting lower gastrointestinal (GI) bleeding," which is a diagnostic purpose.
The definition of an IVD generally includes devices intended for use in the collection, preparation, and examination of specimens taken from the human body for the purpose of providing information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device clearly fits this description.
N/A
Intended Use / Indications for Use
The Innovacon Flipcard™ Fecal Occult Blood Test Device is intended for rapid qualitative detection of human hemoglobin in fecal samples. Fecal occult blood tests are used as a screening tool for detecting lower gastrointestinal (GI) bleeding that may be related to iron deficiency anemia, peptic ulcer, ulcerative colitis, polyp and colorectal cancer. The Flipcard™ FOBT is recommended for use by health professionals in routine physical examinations and in monitoring for GI bleeding in patients in hospitals or at physician's offices.
Product codes
KHE
Device Description
The Innovacon Flipcard™ Fecal Occult Blood Test Device is a rapid test intended for the qualitative detection of low levels Fecal Occult Blood. The test uses monoclonal antibodies to selectively detect human hemoglobin in fecal samples The test uses a double antibody sandwich assay to selectively detect Fecal Occult Blood at 50 ng hHb/mL buffer or 300 ug hHB/g feces. The FOB One Step Fecal Occult Blood Test does not require the patient to follow any special dietary restrictions.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
lower gastrointestinal (GI)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
health professionals in routine physical examinations and in monitoring for GI bleeding in patients in hospitals or at physician's offices.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
A clinical evaluation was conducted using a total of 120 clinical specimens. The detection of human occult blood in clinical fecal specimens was done by using the Innovacon Fecal™ Occult Blood Test Device and Predicate Device, Hemoccult® ICT Immunological Fecal Occult Blood Test
Key Metrics
Part A Sample Collection from Study Participants:
Positive Agreement=2/2 = 100%
Negative Agreement = 115/116 =99.1% (95.3%-100%, 95% CI)
Overall Agreement = 117/118 = 99.2% (95.4%-100%, 95% CI)
Part B Laboratory Study by Professionals:
Positive Agreement=46/48 = 95.8% (85.7%-100%, 95% CI)
Negative Agreement = 100/102 =98.0% (93.1%-99.8%, 95% CI)
Overall Agreement = 146/150 = 97.3% (93.3%-99.3%, 95% CI)
Predicate Device(s)
Hemoccult® ICT Immunological Fecal Occult Blood Test
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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10. SUMMARY OF 510(k)
This summary of 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 K063673_______________________________________________________________________________________________________________________________
Submitter:
.
Innovacon, Inc. 4106 Sorrento Valley Boulevard San Diego, California 92121 Tel.: 858-535-2030 Fax: 858-535-2038
Establishment Registration Number: 3005689981 Owner/Operator Number: 9006731
Date:
11/20/06
Contact Person:
Edward Tung, Ph.D.
Product Name:
Innovacon Flipcard™ Fecal Occult Blood Test Device
Common Name:
Fecal Occult Blood Rapid Test
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Classification Information:
The Innovacon Flipcard™ Fecal Occult Blood Test Device is similar to other FDAcleared devices for the qualitative detection of lower gastrointestinal (GI) bleeding that may be related to iron deficiency anemia, peptic ulcer, ulcerative colitis, polyp and colorectal cancer.
| Classification: | Class II |
|---|---|
| Regulation Number: | 864.6550 |
| Product Code: | KHE |
| Classification Name: | Reagent Occult Blood |
| Complexity: | Waived |
| Analyte: | Fecal Occult Blood |
| Test Category: | Manual procedures with limited steps and limited sample and reagent preparation |
Intended Use:
The Innovacon Flipcard™ Fecal Occult Blood Test Device is intended for rapid qualitative detection of human hemoglobin in fecal samples. Fecal occult blood tests are used as a screening tool for detecting lower gastrointestinal (GI) bleeding that may be related to iron deficiency anemia, peptic ulcer, ulcerative colitis, polyp and colorectal cancer. The Flipcard™ FOBT is recommended for use by health professionals in routine physical examinations and in monitoring for GI bleeding in patients in hospitals or at physician's offices.
Description:
The Innovacon Flipcard™ Fecal Occult Blood Test Device is a rapid test intended for the qualitative detection of low levels Fecal Occult Blood. The test uses monoclonal antibodies to selectively detect human hemoglobin in fecal samples The test uses a double antibody sandwich assay to selectively detect Fecal Occult Blood at 50 ng hHb/mL buffer or 300 ug hHB/g feces. The FOB One Step Fecal Occult Blood Test does not require the patient to follow any special dietary restrictions.
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Comparison to Predicate Devices:
A summary of comparison of the features of the Innovacon Flipcard™ Fecal Occult Blood Test Device, and the predicate device is shown below:
| Immunological Fecal Occult Blood Test | ||
|---|---|---|
| Innovacon FlipcardTM | Hemoccult® ICT | |
| Fecal Occult Blood Test | Immunological Fecal | |
| Feature | Device | Occult Blood Test |
| Indication | ||
| for use | A lateral-flow immunoassay intended | |
| for the qualitative detection of human | ||
| hemoglobin in fecal samples | A rapid visually read qualitative | |
| immunochemical chromatographic | ||
| method for detection of human | ||
| hemoglobin in fecal samples. | ||
| Intended Use | Professional | Professional |
| Intended specimen | Fecal | Fecal |
| Endpoint | Colored Lines | Colored Lines |
| Materials provided | Flushable Collection Tissues | |
| Collection Cards | ||
| Collection Sticks | ||
| Protective Pouches | ||
| Mailing Envelopes | ||
| Kit Bags w/Patient Instructions | ||
| FOB Test Devices | ||
| Buffer | ||
| Positive Control | ||
| Negative Control | ||
| Package insert | ||
| Procedure card | Test devices | |
| Buffer | ||
| Package Insert | ||
| Methodology | Membrane particle assay | Membrane particle assay |
| Test Time | 5 minutes | 5 minutes |
| Format | Antigen/antibody immunoassay | Antigen/antibody immunoassay |
Innovacon Flipcard™ Fecal Occult Blood Test Device versus Table 2. Hemoccult® ICT Immunological Fecal Occult Blood Test
Accuracy
A clinical evaluation was conducted using a total of 120 clinical specimens. The detection of human occult blood in clinical fecal specimens was done by using the Innovacon Fecal™ Occult Blood Test Device and Predicate Device, Hemoccult® ICT Immunological Fecal Occult Blood Test
Innovacon Flipcard™ Fecal Occult Blood Test Device compared to Hemoccult® ICT Immunological Fecal Occult Blood Test
Part A Sample Collection from Study Participants
Positive Agreement=2/2 = 100% Negative Agreement = 115/116 =99.1% (95.3%-100%, 95% CI) Overall Agreement = 117/118 = 99.2% (95.4%-100%, 95% CI)
Part B Laboratory Study by Professionals
Positive Agreement=46/48 = 95.8% (85.7%-100%, 95% CI) Negative Agreement = 100/102 =98.0% (93.1%-99.8%, 95% CI) Overall Agreement = 146/150 = 97.3% (93.3%-99.3%, 95% CI)
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/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 top half of the circle. Inside the circle is a stylized image of an eagle or bird-like figure, represented by three curved lines that suggest wings or feathers.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
INNOVACON, INC. C/O Edward Tung 4106 Sorrento Valley Blvd. San Diego, California 92121
MAR 0 5 2007
Re: K063673
Trade/Device Name: Innovacon Flipcard™ Fecal Occult Blood Test Device Regulation Number: 21 CFR 864.6550 Regulation Name: Occult Blood Test Regulatory Class: Class II Product Code: KHE Dated: December 6, 2006 Received: December 11, 2006
Dear Dr. Tung:
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); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0450. 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/industry/support/index.html.
Sincerely yours,
Robert H. Beetal
Robert L. Becker, Jr., MD, PhD Director Division of Immunology and Hematology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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9. INDICATIONS FOR USE
510(k) Number (if known):
Device Name:
Innovacon Flipcard™ Fecal Occult Blood Test Device
1063673
Indications For Use:
The Innovacon Flipcard™ Fecal Occult Blood Test Device is intended for rapid qualitative detection of human hemoglobin in fecal samples. Fecal occult blood tests are used as a screening tool for detecting lower gastrointestinal (GI) bleeding that may be related to iron deficiency anemia, peptic ulcer, ulcerative colitis, polyp and colorectal cancer. The Flipcard™ FOBT is recommended for use by health professionals in routine physical examinations and in monitoring for GI bleeding in patients in hospitals or at physician's offices.
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)
Sign-Off
f Very Device
510(k) K063673 11
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