(224 days)
Not Found
No
The device description details a standard lateral flow immunoassay, and there is no mention of AI, ML, image processing, or any computational analysis of the results. The interpretation is based on the visual presence or absence of colored lines.
No
This device is for the qualitative detection of human occult blood, which is a diagnostic purpose, not a therapeutic one. It identifies a condition but does not treat it.
Yes
The device detects human occult blood in fecal specimens to indicate a positive or negative result, which is a key function of a diagnostic device.
No
The device description clearly outlines a physical lateral flow chromatographic immunoassay, which is a hardware-based test. It involves a membrane, particle coatings, and capillary action to produce a visible colored line. This is not a software-only device.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "for the qualitative detection of human occult blood in human fecal specimens." This is a diagnostic test performed on a biological sample (fecal specimen) in vitro (outside the body).
- Device Description: The description details a "rapid chromatographic immunoassay" that analyzes a specimen to detect a specific analyte (human occult blood). This is a common method for IVD tests.
- Performance Studies: The document includes detailed performance studies such as detection limit, reproducibility, and accuracy, which are standard requirements for demonstrating the performance of an IVD device.
- Predicate Device: The mention of a "Predicate Device" (K070660 - INSTANT-VIEW® Fecal Occult Blood (FOB) Rapid Test) further confirms its classification as an IVD, as predicate devices are used for comparison in the regulatory submission process for new IVDs.
The fact that it is suitable for use in laboratories, physician's offices, and for Over the Counter Use also aligns with the typical distribution and use cases for IVD devices.
N/A
Intended Use / Indications for Use
The FOB One Step Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of human occult blood in human fecal specimens. The device is suitable for use in laboratories and physician's offices as well as for Over the Counter Use.
Indications for Use The FOB One Step Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of human occult blood in human fecal specimens. The device is suitable for use in laboratories and physician's offices as well as for Over the Counter Use.
Product codes
KHE
Device Description
The FOB One Step Rapid Test is a lateral flow chromatographic immunoassay based on the principle of the double antibody-sandwich technique. The membrane is pre-coated with anti-hemoglobin antibody on the test line region of the device. During testing, the specimen reacts with the particle coated with anti-hemoglobin antibody. The mixture migrates upward on the membrane chromatographically by capillary action to react with anti-hemoglobin antibody on the membrane and generate a colored line. The presence of this colored line in the test region indicates a positive result, while its absence indicates a negative result. To serve as a procedural control, a colored line will always appear in the control line region indicating that proper volume of specimen has been added and membrane wicking has occurred.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Fecal specimens
Indicated Patient Age Range
Not Found
Intended User / Care Setting
laboratories and physician's offices as well as for Over the Counter Use.
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)
Performance Characteristics
Detection limit: The sensitivity of the device was tested by spiking 100 hemoglobin-free stool samples with varying concentrations (0, 37.5, 50, 62.5 and 2000ng hHb/ml) of human hemoglobin. The test shows a cutoff of 50ng hHb/mL of buffer solution and no pro-zone effect was seen up to 2000 ng hHb/ml of buffer solution.
Potential Interferences: An interference study was carried out by adding known amounts of potential interfering substances to aqueous fecal samples that contain 0 and 50 ng /mL of human hemoglobin. Substances tested included horseradish peroxidase (20 mg/mL), aqueous extracts of red radish, raw turnip, cauliflower and broccoli, dietary supplements of chloride, Vitamin C (ascorbic acid) and iron, and toilet water with and without cleaner and deodorizer.
Potential Cross Reactors: A cross-reactivity study of animal hemoglobin was carried out by spiking negative (0 ng hHb /mL) and positive (50 ng hHb /mL) fecal samples with no reaction from beef hemoglobin, chicken hemoglobin, fish hemoglobin, horse hemoglobin, goat hemoglobin, pig hemoglobin, rabbit hemoglobin and sheep hemoglobin, respectively, at the concentration of 200 na/mL.
REPRODUCIBILITY
Inter-Site: 75 hemoglobin-free fecal samples spiked with varying levels (0. 37.5. 50. 62.5. and 2000 ng hHd/mL) of human hemoglobin were tested at 3 medical laboratories with 3 lots of tests and run 5 times each lot at each site.
Intra-Run: 3 lots of test cassettes were tested by spiking 50 hemoglobin-free fecal samples with varying levels (0, 37.5, 50, 62.5, and 2000 ng hHg/ml) of human hemoglobin and run 10 times each.
Inter-Day: Cassettes from the same lot were tested with 50 fecal samples spiked with varying levels (0, 37.5, 50, 62.5, and 2000 ng hHg/ml) of human hemoglobin on 3 consecutive days with 10 replicates each day.
ACCURACY
A study was conducted to evaluate the Fecal Occult Blood Rapid Test and compare results with a commercially available Fecal Occult Blood Rapid Test at three physician office laboratories by technical personnel, and one medical laboratory by non-technical personnel with diverse educational backgrounds and ages.
Consumer results:
Study of technical personnel: In each POL site, 100 human stool extraction samples were spiked with human hemoglobin at the following concentrations: 0, 37.5, 50, 62.5, and 500 ng/ml (20 replicates at each concentration). Results obtained from 3 sites agreed 99.0% with the expected results and 98.0% with results of predicated device.
Study of non-technical personnel: 150 human stool extraction samples were spiked with hHb at the following concentrations: 0. 37.5, 50, 62.5, and 500ng/ml (30 at each concentration). Thirty (30) participants without technical background were enrolled to conduct the study in a medical laboratory. Each participant tested 5 samples (1 at each concentration) with the two FOB devices.
Results generated by 3 trained technicians with the Orient Gene FOB One Step Rapid Test as compared to the predicate test: Percent Positive Agreement = 59/60 = 98.3% (95% C.1. = 91.1% - 100%) Percent Negative Agreement = 39/40 = 97.5% (95% C.I. = 86.8% - 99.9%) Overall Agreement = 98/100= 98.0% (95% C.I. = 93.0% - 99.8%)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity: 50ng hHb/mL of buffer solution
Percent Positive Agreement = 98.3% (95% C.1. = 91.1% - 100%)
Percent Negative Agreement = 97.5% (95% C.I. = 86.8% - 99.9%)
Overall Agreement = 98.0% (95% C.I. = 93.0% - 99.8%)
Predicate Device(s)
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.
0
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: K110309
| Submitted By: | Zhejiang Orient Gene Biotech Co., LTD
Ji'er Road, Jiankang Industrial Area (Medicine),
Anji Economic Development Zone, Zhejiang, China, 313300 |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Tel: +86-572-5226111 E-mail:sales@orientgene.com
Fax: +86-572-5226222 Web site: www.orientgene.com |
| Official Correspondent: | Gary Lehnus
Lehnus & Associates Consulting |
| Telephone | (570) 620-0198 |
| FAX | (570) 620-0199 |
| Date Prepared: | January 28, 2011 |
| Device Name | Trade or Proprietary Name: Orient Gene Biotech - One Step Rapid FOB
Common or Usual Name: Fecal Occult Blood Test. |
| Regulation | 21 CFR 864.6550 |
| Classification | Class II |
| Product Codes | KHE |
| Panel: | Hematology |
| Predicate Device: | K070660 - INSTANT-VIEW® Fecal Occult Blood (FOB) Rapid Test |
| Device Description | The FOB One Step Rapid Test is a lateral flow chromatographic
immunoassay based on the principle of the double antibody-sandwich
technique. The membrane is pre-coated with anti-hemoglobin antibody on
the test line region of the device. During testing, the specimen reacts with
the particle coated with anti-hemoglobin antibody. The mixture migrates
upward on the membrane chromatographically by capillary action to react
with anti-hemoglobin antibody on the membrane and generate a colored
line. The presence of this colored line in the test region indicates a positive
result, while its absence indicates a negative result. To serve as a
procedural control, a colored line will always appear in the control line region
indicating that proper volume of specimen has been added and membrane
wicking has occurred. |
| Intended Use | The FOB One Step Rapid Test is a rapid chromatographic immunoassay for
the qualitative detection of human occult blood in human fecal specimens. |
l
1
The device is suitable for use in laboratories and physician's offices as well as for Over the Counter Use.
Indications for Use The FOB One Step Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of human occult blood in human fecal specimens. The device is suitable for use in laboratories and physician's offices as well as for Over the Counter Use.
SUBSTANTIAL EQUIVALENCE
The following tables summarize similarities and differences between FOB One Step Rapid Test and the current INSTANT-VIEW® Fecal Occult Blood (FOB) Rapid Test.
| Item | INSTANT-VIEW® Fecal Occult Blood
(FOB) Rapid Test Predicate | FOB One Step Rapid Test |
|--------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Instant-View® Fecal Occult
Blood (FOB) Rapid Test is a rapid
qualitative test for the
immunochemical detection of fecal
occult blood/human hemoglobin
(hHb) in human fecal specimens as
an aid in the diagnosis of
gastrointestinal disorders such as:
diverticulitis, colitis, polyps, and
colorectal cancer. The device is
suitable for use in laboratories and
physician's offices as well as for
home use. | The FOB One Step Rapid Test is a
rapid chromatographic
immunoassay for the qualitative
detection of human occult blood in
human fecal specimens as an
aid in the diagnosis of
gastrointestinal disorders such
as: diverticulitis, colitis, polyps,
and colorectal cancer. The
device is suitable for use in
laboratories and physician's
offices as well as for Over the
Counter use. |
| Specimen | Fecal | Same |
| Sensitivity | 0.05 µg hHb/mL | Same -50 ng hHb/mL |
| Storage | 2 - 30°C | Same |
| Principle | Sandwich Immunochromatographic
Assay | Same |
| Read Time | 5 Minutes | 5 minutes |
| Test Line | Membrane Immunoassay | Colloidal Gold |
2
Performance Characteristics
The following are performance characteristics of FOB One Step Rapid Test
Detection limit:
The sensitivity of the device was tested by spiking 100 hemoglobin-free stool samples with varying concentrations (0, 37.5, 50, 62.5 and 2000ng hHb/ml) of human hemoglobin. The test shows a cutoff of 50ng hHb/mL of buffer solution and no pro-zone effect was seen up to 2000 ng hHb/ml of buffer solution. Result are summarized below:
| hHb concentration
| (ng/mL) | Total | Positive | Negative |
|---|---|---|---|
| 0 | 20 | 0 | 20 |
| 37.5 | 20 | 0 | 20 |
| 50. | 20 | 20 | 0 |
| 62.5 | 20 | 20 | 0 |
| 2000 | 20 | 20 | 0 |
Potential Interferences
An interference study was carried out by adding known amounts of potential interfering substances to aqueous fecal samples that contain 0 and 50 ng /mL of human hemoglobin. Substances tested included horseradish peroxidase (20 mg/mL), aqueous extracts of red radish, raw turnip, cauliflower and broccoli, dietary supplements of chloride, Vitamin C (ascorbic acid) and iron, and toilet water with and without cleaner and deodorizer.
Potential Cross Reactors:
A cross-reactivity study of animal hemoglobin was carried out by spiking negative(0 ng hHb /mL) and positive(50 ng hHb /mL) fecal samples with no reaction from beef hemoglobin, chicken hemoglobin, fish hemoglobin, horse hemoglobin, goat hemoglobin, pig hemoglobin, rabbit hemoglobin and sheep hemoglobin, respectively, at the concentration of 200 na/mL.
REPRODUCIBILITY
Inter-Site
To evaluate reproducibility of the test, 75 hemoglobin-free fecal samples spiked with varying levels (0. 37.5. 50. 62.5. and 2000 ng hHd/mL) of human hemoglobin were tested at 3 medical laboratories with 3 lots of tests and run 5 times each lot at each site. The results are summarized below:
| 3 Sites | Total
Results | Lot 1 | Lot 2 | Lot 3 |
|-------------------|------------------|--------|--------|--------|
| Hb concentrations | | P / N | P / N | P / N |
| 0 ng/mL | 45 | 0 / 15 | 0 / 15 | 0 / 15 |
| 37.5 ng/mL | 45 | 0 / 15 | 0 / 15 | 0 / 15 |
| 50 ng/mL | 45 | 15 / 0 | 15 / 0 | 15 / 0 |
| 62.5 ng/mL | 45 | 15 / 0 | 15 / 0 | 15 / 0 |
| 2,000 ng/mL | 45 | 15 / 0 | 15 / 0 | 15 / 0 |
3
Intra-Run
Intra-Run reproducibility was determined by testing 3 lots of test cassettes by spiking 50 hemoglobin-free fecal samples with varying levels(0, 37.5, 50, 62.5, and 2000 ng hHg/ml) of human hemoglobin and run 10 times each. The results are summarized below:
| | Total
Results | Lot 1 | Lot 2 | Lot 3 |
|-------------------|------------------|--------|--------|--------|
| Hb concentrations | | P / N | P / N | P / N |
| 0 ng/mL | 30 | 0 / 10 | 0 / 10 | 0 / 10 |
| 37.5 ng/mL | 30 | 0 / 10 | 0 / 10 | 0 / 10 |
| 50 ng/mL | 30 | 10 / 0 | 10 / 0 | 10 / 0 |
| 62.5 ng/mL | 30 | 10 / 0 | 10 / 0 | 10 / 0 |
| 2,000 ng/mL | 30 | 10 / 0 | 10 / 0 | 10 / 0 |
Inter-Day
Day to day reproducibility study was carried out by testing cassettes from the same lot with 50 fecal samples spiked with varying levels (0, 37.5, 50, 62.5, and 2000 ng hHg/ml) of human hemoglobin on 3 consecutive days with 10 replicates each day. The results are summarized below:
| 3 days | Total Results | Lot 1 | Lot 2 | Lot 3 |
|---|---|---|---|---|
| Hb concentrations | P / N | P / N | P / N | |
| 0 ng/mL | 30 | 0 / 10 | 0 / 10 | 0 / 10 |
| 37.5 ng/mL | 30 | 0 / 10 | 0 / 10 | 0 / 10 |
| 50 ng/mL | 30 | 10 / 0 | 10 / 0 | 10 / 0 |
| 62.5 ng/mL | 30 | 10 / 0 | 10 / 0 | 10 / 0 |
| 2,000 ng/mL | 30 | 10 / 0 | 10 / 0 | 10 / 0 |
ACCURACY
A study was conducted to evaluate the Fecal Occult Blood Rapid Test and compare results with a commercially available Fecal Occult Blood Rapid Test at three physician office laboratories by technical personnel, and one medical laboratory by non-technical personnel with diverse educational backgrounds and ages.
Consumer results using the FOB One Step Rapid Test compared to both the professional and Predicate test results were evaluated:
Study of technical personnel
In each POL site, 100 human stool extraction samples were spiked with human hemoglobin at the following concentrations: 0, 37.5, 50, 62.5, and 500 ng/ml (20 replicates at each concentration). Results obtained from 3 sites agreed 99.0% with the expected results and 98.0% with results of predicated device.
Study of non-technical personnel
150 human stool extraction samples were spiked with hHb at the following concentrations: 0. 37.5, 50, 62.5, and 500ng/ml (30 at each concentration). Thirty (30) participants without technical background were enrolled to conduct the study in a medical laboratory. Each participant tested 5 samples (1 at each concentration) with the two FOB devices.
4
| Tests (tester) | Total
Evaluated
Samples | Correct
Results | Discrepant
Results | Agree
ment |
|----------------------------------------------------|-------------------------------|--------------------|-----------------------|---------------|
| Orient Gene FOB Test
Layuser vs. Expected | 150 | 148 | 2 | 98.7% |
| Orient Gene FOB Test
Layuser vs. Predicate test | 150 | 147 | 3 | 98.0% |
| Orient Gene FOB
technicians vs Expected | 100 | 99 | 1 | 99.0% |
| Orient Gene FOB
Technician vs Predicate
test | 100 | 98 | 2 | 98.0% |
Results generated by 3 trained technicians with the Orient Gene FOB One Step Rapid Test as compared to the predicate test:
| Predicate test | Total Results | ||||
|---|---|---|---|---|---|
| Orient | Gene | Results | Positive | Negative | |
| FOB Test | Positive | 59 | 1 | 60 | |
| Negative | 1 | 39 | 40 | ||
| Total Results | 60 | 40 | 100 |
Percent Positive Agreement = 59/60 = 98.3% (95% C.1. = 91.1% - 100%) Percent Negative Agreement = 39/40 = 97.5% (95% C.I. = 86.8% - 99.9%) Overall Agreement = 98/100= 98.0% (95% C.I. = 93.0% - 99.8%)
5
Image /page/5/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The eagle is positioned to the right of the seal's center. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Orient Gene Biotech c/o Mr. Gary Lehnus Lehnus & Associates Consulting 150 Cherry Lane Road East Stroudsburg, PA 18301
SEP 1 4 2011
Re: K110309
Trade/Device Name: FOB One Step Rapid Test Regulation Number: 21 CFR 864.6550 Regulation Name: Occult blood test Regulatory Class: Class II Product Code: KHE Dated: July 5, 2011 Received: July 27, 2011
Dear Mr. Lehnus:
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 class II (Special Controls), 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); medical device reporting of medical device-related adverse events) (21 CFR 803); and 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 FDA finding of
6
Page 2 - Mr. Gary Lehnus
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 Parts 801 and 809). please contact the Office of In Viro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR 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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours.
ြင္း
Ravi Philip
Maria M. Chan, Ph.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
7
Indications for Use
510(k) Number (if known): K110309
Device Name: _________ FOB One Step Rapid Test
Indications For Use:
The FOB One Step Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of human occult blood in human fecal specimens. The device is suitable for use in laboratories and physician's offices as well as for home use.
Prescription Use X (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 Device Evaluation (OIVD)
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
KIID309 510(k)
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