FOB ONE STEP RAPID TEST

K110309 · Orient Gene Biotech · KHE · Sep 14, 2011 · Hematology

Device Facts

• Record ID: K110309
• Device Name: FOB ONE STEP RAPID TEST
• Applicant: Orient Gene Biotech
• Product Code: KHE · Hematology
• Decision Date: Sep 14, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.6550
• Device Class: Class 2

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. The device is suitable for use in laboratories and physician's offices as well as for home use.

Device Story

FOB One Step Rapid Test is a lateral flow chromatographic immunoassay; utilizes double antibody-sandwich technique. Input: human fecal specimen. Principle: specimen reacts with anti-hemoglobin antibody-coated particles; mixture migrates via capillary action across membrane pre-coated with anti-hemoglobin antibody. Output: colored line in test region indicates positive result (presence of human hemoglobin); colored line in control region confirms proper wicking/volume. Used in laboratories, physician offices, and home settings; operated by technicians or lay users. Healthcare providers interpret visual lines to aid diagnosis of gastrointestinal disorders. Benefits patient by providing rapid, qualitative screening for occult blood.

Clinical Evidence

Bench testing only. Sensitivity/cutoff established at 50 ng hHb/mL. Reproducibility evaluated via inter-site, intra-run, and inter-day studies using spiked fecal samples (0-2000 ng/mL) across 3 lots; results showed consistent performance. Accuracy study compared device against predicate using 100 samples (technical personnel) and 150 samples (lay users). Technical personnel agreement: 99.0% with expected results, 98.0% with predicate. Lay user agreement: 98.7% with expected results, 98.0% with predicate. Cross-reactivity testing showed no interference from animal hemoglobins (beef, chicken, fish, horse, goat, pig, rabbit, sheep) at 200 ng/mL.

Technological Characteristics

Lateral flow chromatographic immunoassay; double antibody-sandwich technique. Employs colloidal gold particles. Dimensions/form factor: test cassette. Storage: 2-30°C. No electronic components, software, or external energy source required. Manual operation.

Indications for Use

Indicated for qualitative detection of human occult blood in fecal specimens to aid in diagnosis of gastrointestinal disorders. Suitable for use by healthcare professionals in laboratories and physician offices, and for over-the-counter (OTC) use by lay persons.

Regulatory Classification

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.)

Special Controls

*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.

Predicate Devices

• INSTANT-VIEW® Fecal Occult Blood Rapid Test (k070660)

Submission Summary (Full Text)

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# 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<br>Ji'er Road, Jiankang Industrial Area (Medicine),<br>Anji Economic Development Zone, Zhejiang, China, 313300 |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Tel: [phone] E-mail:[e-mail]<br>Fax: [phone] Web site: www.orientgene.com |
| Official Correspondent: | Gary Lehnus<br>Lehnus & Associates Consulting |
| Telephone | [phone] |
| FAX | [phone] |
| Date Prepared: | January 28, 2011 |
| Device Name | Trade or Proprietary Name: Orient Gene Biotech - One Step Rapid FOB<br>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<br>immunoassay based on the principle of the double antibody-sandwich<br>technique. The membrane is pre-coated with anti-hemoglobin antibody on<br>the test line region of the device. During testing, the specimen reacts with<br>the particle coated with anti-hemoglobin antibody. The mixture migrates<br>upward on the membrane chromatographically by capillary action to react<br>with anti-hemoglobin antibody on the membrane and generate a colored<br>line. The presence of this colored line in the test region indicates a positive<br>result, while its absence indicates a negative result. To serve as a<br>procedural control, a colored line will always appear in the control line region<br>indicating that proper volume of specimen has been added and membrane<br>wicking has occurred. |
| Intended Use | The FOB One Step Rapid Test is a rapid chromatographic immunoassay for<br>the qualitative detection of human occult blood in human fecal specimens. |

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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<br>(FOB) Rapid Test Predicate | FOB One Step Rapid Test |
|--------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Instant-View® Fecal Occult<br>Blood (FOB) Rapid Test is a rapid<br>qualitative test for the<br>immunochemical detection of fecal<br>occult blood/human hemoglobin<br>(hHb) in human fecal specimens as<br>an aid in the diagnosis of<br>gastrointestinal disorders such as:<br>diverticulitis, colitis, polyps, and<br>colorectal cancer. The device is<br>suitable for use in laboratories and<br>physician's offices as well as for<br>home use. | The FOB One Step Rapid Test is a<br>rapid chromatographic<br>immunoassay for the qualitative<br>detection of human occult blood in<br>human fecal specimens as an<br>aid in the diagnosis of<br>gastrointestinal disorders such<br>as: diverticulitis, colitis, polyps,<br>and colorectal cancer. The<br>device is suitable for use in<br>laboratories and physician's<br>offices as well as for Over the<br>Counter use. |
| Specimen | Fecal | Same |
| Sensitivity | 0.05 µg hHb/mL | Same -50 ng hHb/mL |
| Storage | 2 - 30°C | Same |
| Principle | Sandwich Immunochromatographic<br>Assay | Same |
| Read Time | 5 Minutes | 5 minutes |
| Test Line | Membrane Immunoassay | Colloidal Gold |

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## 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<br>(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<br>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 |

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#### 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<br>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.

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| Tests (tester) | Total<br>Evaluated<br>Samples | Correct<br>Results | Discrepant<br>Results | Agree<br>ment |
|----------------------------------------------------|-------------------------------|--------------------|-----------------------|---------------|
| Orient Gene FOB Test<br>Layuser vs. Expected | 150 | 148 | 2 | 98.7% |
| Orient Gene FOB Test<br>Layuser vs. Predicate test | 150 | 147 | 3 | 98.0% |
| Orient Gene FOB<br>technicians vs Expected | 100 | 99 | 1 | 99.0% |
| Orient Gene FOB<br>Technician vs Predicate<br>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%)

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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

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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 [phone]. 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 [phone] or [phone] 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

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# 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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