OSOM IFOB 25 TEST AND PATIENT COLLECTION KIT OSOM IFOB CONTROL KIT OSOM IFOB 50 TEST KIT
Device Facts
| Record ID | K121397 |
|---|---|
| Device Name | OSOM IFOB 25 TEST AND PATIENT COLLECTION KIT OSOM IFOB CONTROL KIT OSOM IFOB 50 TEST KIT |
| Applicant | SEKISUI Diagnostics, LLC |
| Product Code | KHE · Hematology |
| Decision Date | Dec 28, 2012 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 864.6550 |
| Device Class | Class 2 |
Intended Use
The OSOM iFOB (Immunochemical Fecal Occult Blood) Test is a rapid immunoassay for the qualitative detection of fecal occult blood by laboratories or physicians' offices. It is useful for the detection of human hemoglobin in human fecal samples and is recommended for use as part of routine physical examinations or when lower gastrointestinal disorders are suspected. The OSOM iFOBT Control Kit is intended for use in quality control testing with the OSOM iFOB Test.
Device Story
Rapid immunochromatographic lateral flow assay; detects human hemoglobin (hHb) in fecal samples. Input: fecal sample collected on card, extracted in buffer, dispensed into test device. Principle: sample migrates across membrane with anti-hHb capture antibody; hHb binds to blue latex-conjugated monoclonal mouse anti-hHb antibody. Output: visual blue test line (positive) and red control line (validity). Used in laboratories/physician offices; performed by clinicians/technicians. Results aid in identifying GI bleeding; supports clinical decision-making for further diagnostic investigation. Benefits: non-invasive screening for GI disorders.
Clinical Evidence
Bench testing only. Reproducibility study across 3 physician office labs and 1 internal site (n=542) showed 98.5% overall agreement. Analytical sensitivity established at 50 ng/mL. Method comparison against predicate (n=125) showed 99.2% agreement. No clinical studies performed.
Technological Characteristics
Lateral flow immunochromatographic assay. Capture antibody: goat polyclonal anti-hHb. Detection antibody: monoclonal mouse anti-hHb conjugated to blue latex. Detection limit: 50 ng/mL. Result format: visual blue test line, red control line. Standalone test kit; no electronic components or software.
Indications for Use
Indicated for qualitative detection of human hemoglobin in human fecal samples in patients undergoing routine physical exams or suspected of having lower gastrointestinal disorders.
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
- Alfa Scientific Designs' Instant-View Fecal Occult Blood Rapid Test (currently marketed as Quidel QuickVue iFOB Test) (k021423)
Related Devices
- K100817 — BIOSIGN IFOBTEST, BIOSIGN FECAL OCCULT BLOOD TEST · Princeton BioMeditech Corp. · Jul 1, 2010
Submission Summary (Full Text)
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# Sekisui Diagnostics
#### 510(k) Summary of Safety and Effectiveness Section 5.
# DEC 2 8 2012
This 510(k) summary of safety and effectiveness is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is: ___ K \2\1397
#### Sponsor/Applicant Name and Address 1.
Company Name: Address:
Sekisui Diagnostics, LLC 6659 Top Gun Street San Diego, CA 92121
Telephone:
Contact Person:
858-777-2633
Mark Stavro Director, Regulatory Affairs
Date Summary Prepared:
05/07/2012
#### Device Name and Classification 2.
Trade Name:
OSOM® iFOB Test OSOM® iFOBT Control Kit
21 CFR 864.6550; Occult blood test Classification of Device:
Product Code:
KHE
Class II
Classification:
3.
# Predicate Device
K021423 -- Alfa Scientific Designs' Instant-View Fecal Occult Blood Rapid Test (Currently marketed as Quidel QuickVue iFOB Test).
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#### 4. Device Description
The OSOM iFOB (Immunochemical Fecal Occult Blood) Test is a rapid test which can detect the presence of occult blood in human fecal samples by detecting the presence of human hemoglobin (hHb). The OSOM iFOB Test is a qualitative assay that employs immuochromatographic, lateral flow technology. A test kit contains 25 pouched Test Devices, 25 Extraction Reagent vials, 25 conjugate vial tips, and 25 sample collection packs. Tests and Reagents are also available in a 50-test kit without sample collection packs, and sample collection packs are available separately in a package of 50. Negative and positive external controls are provided separately as the OSOM iFOBT Control Kit.
The fecal sample collected using an OSOM iFOB sample collection card is placed into a prefilled vial containing Extraction Buffer. This test solution is then dispensed, through a dropper tip containing human hemoglobin antibody conjugated to latex, into the sample well of the Test Device. The sample migrates across the membrane containing a Test line coated with anti-human hemoglobin antibody and a Control line. If hemoglobin is present at or above the level of detection of the test, an antigen/antibody complex will be formed. The appearance of a visible blue Test line and a red Control line in the result window indicates the presence of human hemoglobin in the sample. A red control line must appear for the results to be valid. If a detectable level of hemoglobin is not present, only the red control line will appear. An invalid test occurs when no control line appears.
The control line serves as an internal procedural control, indicating that the test system is functioning correctly and that the operator added a sufficient volume of sample. In addition to the internal control in each Test Device, external controls are available in a separate OSOM iFOBT Control Kit. The Negative Control (buffer solution) and the Positive Control (hHb in buffer solution) are run in the iFOB Test in the same manner as an extracted fecal sample.
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#### 5. Intended Use
The OSOM iFOB (Immunochemical Fecal Occult Blood) Test is a rapid immunoassay for the qualitative detection of fecal occult blood by laboratories or physicians' offices. It is useful for the detection of human hemoglobin in human fecal samples and is recommended for use as part of routine physical examinations or when lower gastrointestinal disorders are suspected.
#### б. Comparison to Predicate Device
The Table below provides a summary of the device characteristics for the OSOM iFOB Test and the predicate device.
| Device<br>Characteristics | OSOM iFOB Test<br>[New Device] | Alfa Instant-View FOB Rapid<br>Test<br>[Predicate/ K021423] |
|----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | A rapid immunoassay for the<br>qualitative detection of fecal occult<br>blood by laboratories or<br>physicians' offices. It is useful for<br>the detection of human<br>hemoglobin in human fecal<br>samples and is recommended for<br>use as part of routine physical<br>examinations or when lower<br>gastrointestinal disorders are<br>suspected. | An immunochemical device<br>intended for the qualitative<br>detection of Fecal Occult Blood by<br>laboratories or physicians' offices.<br>It is useful in determining<br>gastrointestinal (GI) bleeding<br>found in a number of GI disorders,<br>such as diverticulitis, colitis,<br>polyps, and colorectal cancer.<br>Recommended for use in routine<br>physical examinations, hospital<br>monitoring for bleeding patients,<br>and screening for colorectal cancer<br>or GI bleeding from any source. |
| Specifically<br>detecting: | Qualitative<br>Human hemoglobin (hHb) | Qualitative<br>Human hemoglobin |
| Specimen | Human fecal specimen | Human fecal specimen |
| Detection Level | 50 ng hHb/mL | 50 ng hHb/mL |
| Assay Method | Immunochromatographic<br>membrane assay | Immunochromatographic<br>membrane assay |
| Result Format | Negative: Visible red Control line | Negative: Single visible burgundy<br>line |
## Table 1: Comparison of Technological Characteristics of Sekisui Diagnostics OSOM iFOB Test with Legally Marketed Device
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# Sekisui Diagnostics
| | Positive: Visible red Control line<br>and visible blue Test line | Positive: 2 visible burgundy lines |
|------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Antibodies | Capture: Goat polyclonal anti-hHb<br>Detection: Monoclonal mouse anti-hHb conjugated to blue latex | Capture: Anti-hHb antibodies<br>Detection: Monoclonal mouse anti-hHb conjugated to colloidal gold |
| Internal Control | Visible red Control line | Visible burgundy line |
| External Controls | Negative: Buffer solution<br>Positive: hHb in buffer solution<br>Provided separately | Negative: Buffer solution<br>Positive: hHb in buffer solution<br>Provided separately |
| Sample Collection<br>and Transport | Provided applicator stick is used to<br>collect a small portion of feces and<br>apply to sample collection card.<br>Dry card is transported in mailing envelope | Provided grooved sample<br>collection probe is used to collect<br>fecal sample, which is inserted in<br>buffer tube.<br>Buffer tube is transported in<br>mailing envelope |
| Time to Result | 5 minutes | 5-10 minutes |
#### Summary of Performance Data 7.
## Reproducibility and Detection Limit
To demonstrate the reproducibility and limit of detection of the OSOM iFOB Test, an evaluation was conducted at three external physician office (POL) sites and one internal site using three lots of OSOM iFOB Test. Each site tested randomly coded panels of fecal samples spiked with human blood with known concentrations of hemoglobin A at five different concentrations: 0, 37.5, 50, 62.5, and 2000 ng/mL. Each panel consisted of 15 test samples, 3 of each of the 5 hemoglobin concentration levels, dried onto an OSOM iFOB sample collection card.
Testing was performed at the external POL sites by 3 intended users per site, with varying levels of education and work experience. Testing at Sekisui Diagnostics, the reference site, was performed by two experience laboratory professionals. Each POL operator tested, in a random fashion, 1 panel on each of the 3 lots of the OSOM iFOB Test. The Sekisui site tested the same number of samples as the 3 external sites, but the testing was divided between two operators. Testing was
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performed on three non-consecutive days, and all operators were blinded to the test sample analyte levels.
The detection level of the OSOM iFOB Test is 50 ng/mL, so the 0 and 37.5 ng/mL hemoglobin levels are expected to have negative results and the 50, 62.5, and 2000 ng/mL levels are expected to have positive results. Test results are summarized in Table 2.
| | Expected | | |
|----------|----------|----------|-------|
| OSOM | Positive | Negative | Total |
| Positive | 320 | 3 | 323 |
| Negative | 5 | 214 | 219 |
| Total | 325 | 217 | 542 |
Table 2: OSOM iFOB Reproducibility
The results obtained by the three POL sites and the reference laboratory had an overall agreement of 98.5% (95% CI: 97.4% - 99.0%) to the expected results, with positive percent agreement of 98.5% (95% CI: 96.4% - 99.3%), and a negative percent agreement of 98.6% (95% CI: 96.0 - 99.5%).
The study confirmed the detection level of 50 ng/mL and demonstrated that the OSOM iFOB test produces reproducible results when tested by multiple intended users at multiple sites, on multiple days, over multiple reagent lots.
## Sensitivity to Hemoglobin Variants
Human hemoglobin S (hHBS) samples and human hemoglobin C (hHbC) samples were prepared at 50, 100, and 2,000 ng/mL Hb and tested with three lots of OSOM iFOB Test. Results of the testing were all positive, indicating that OSOM iFOB Test detects the presence of HbS and HbC at concentrations of 50 ng/mL and higher.
### Hook Effect
Samples with elevated levels of hHbA (2,000 ng/mL), hHbS (2,000 ng/mL), and hHbC (2,000 ng/mL) were prepared and tested with three lots of OSOM iFOB
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reagents. Results for all samples were positive, demonstrating that there is no hook (prozone) effect at a hemoglobin level of 2,000 ng/mL.
## Performance Compared to a Commercially Available Device
A method comparison study was performed to compare the performance of OSOM iFOB Test to a commercially available predicate device, Alfa Instant-View FOB Rapid Test (K021423), currently marketed as Quicel's QuickVue iFOB Test. Fecal samples were spiked with human blood with known concentrations of hemoglobin A at five different concentrations: 0, 37.5, 50, 62.5, and 2,000 ng/mL. Samples were applied to OSOM iFOB sample collection cards, dried, and tested with the OSOM iFOB Test. Samples for QuickVue testing were transferred to the provided collection tube according to the QuickVue instructions and tested with the QuickVue iFOB Test. Twenty-five replicates of each hemoglobin concentration were tested with each test.
Overall results of the OSOM iFOB Test were compared directly against the QuickVue Test results. A summary of the comparison is provided in Table 3.
| | QuickVue | | |
|----------|----------|----------|-------|
| OSOM | Positive | Negative | Total |
| Positive | 75 | 1 | 76 |
| Negative | 0 | 49 | 49 |
| Total | 75 | 50 | 125 |
Table 3: Comparison of OSOM to QuickVue
Overall agreement of OSOM iFOB with QuickVue was determined to be 99.2% (95% CI: 96.0 - 99.5%). Positive agreement was 100% (95% CI: 95.1 - 100.0%) and negative agreement was 98.0% (95% CI: 89.5 0 99.6%). The Method Comparison study demonstrated that the analytical performance of OSOM iFOB Test is substantially equivalent to that of QuickVue iFOB Test.
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## Cross-Reactivity
Human myoglobin, various nonhuman hemoglobins and myoglobins or meat extracts were added to fecal extract samples at the levels shown in Table 4 and all samples were tested with the OSOM iFOB Test. All test results were negative, indicating no cross-reactivity with any of the substances tested.
| Potential Cross-Reactant | Concentration |
|--------------------------|---------------|
| Human Mb | 500 µg/mL |
| Sheep Hb | 500 µg/mL |
| Horse Hb | 500 µg/mL |
| Bovine Hb | 2,000 µg/mL |
| Porcine Hb | 500 µg/mL |
| Chicken Hb | 500 µg/mL |
| Rabbit Hb | 500 µg/mL |
| Fish Hb | 500 µg/mL |
| Goat Hb | 500 µg/mL |
| Horse Mb | 500 µg/mL |
| Sheep meat extract | 500 µg/mL |
| Beef meat extract | 500 µg/mL |
| Pig meat extract | 500 µg/mL |
| Chicken meat extract | 500 µg/mL |
| Rabbit meat extract | 500 µg/mL |
| Fish meat extract | 500 µg/mL |
| Goat meat extract | 500 µg/mL |
Table 4: Potentially Cross-Reacting Substances
### Interfering Substances
A study was performed to determine the impact on the OSOM iFOB Test when potentially interfering substances typically found in feces were spiked into fecal extract samples with and without 50 ng/mL hHbA. Each of the potential interferents listed in Table 5 was spiked into a Negative fecal extract sample and a Positive (50 ng/mL Hb) fecal extract sample. All samples were tested with the OSOM iFOB Test. Results are summarized in Table 5. No interference was observed for any of the potentially interfering substances tested.
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| Table 5: Potentially Interfering Substances | | |
|---------------------------------------------|----------------------------|----------------------------|
| Potential Interferent | Negative<br>Sample Results | Positive<br>Sample Results |
| Horseradish Peroxidase,<br>20,000 µg/mL | Negative | Positive |
| Broccoli (aqueous extract) | Negative | Positive |
| Turnip (aqueous extract) | Negative | Positive |
| Parsnip (aqueous extract) | Negative | Positive |
| Cauliflower (aqueous extract) | Negative | Positive |
| Cantaloupe (aqueous extract) | Negative | Positive |
| Red radish (aqueous extract) | Negative | Positive |
| Vitamin C, 0.25 mg/mL | Negative | Positive |
| Iron, 0.065 mg/mL | Negative | Positive |
| No interfering substance | Negative | Positive |
#### 8. Conclusion
The information presented in this Premarket Notification demonstrates that the performance of the OSOM iFOB Test is substantially equivalent in intended use, technological characteristics, and performance to the predicate device, thereby supporting 510(k) clearance.
Equivalence was demonstrated using manufactured reagents along with quality control materials and human fecal samples with defined levels of human hemoglobin.
The studies in this submission demonstrate the substantial equivalence of the OSOM iFOB Test to products already marketed for the qualitative detection of occult blood in human fecal samples.
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### DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/8/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a snake entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol.
#### Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Sekisui Diagnostics, LLC c/o Mr. Mark Stavro Director of Regulatory Affairs 6659 Top Gun Street San Diego, California 92121
Re: k121397
Trade/Device Name: OSOM® iFOB Test
### OSOM® iFOBT Control Kit
Regulation Number: 21 CFR §864.6550 Regulation Name: Occult blood test Regulatory Class: II Product Code: KHE Dated: November 27, 2012 Received: November 28, 2012
### Dear Mr. Stavro:
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
## DEC 2 8 2012
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Page 2 - Mr. Mark Stavro
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/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/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
**Joshua** D. Levin -S
for Maria M. Chan, Ph.D.
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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# Sekisui Diagnostics
OSOM® iFOB Test 510(k) Premarket Notification
## Statement of Intended Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
OSOM iFOBT Control Kit Device Name:
## Indications for Use:
The OSOM iFOBT Control Kit is intended for use in quality control testing with the OSOM iFOB Test.
| Prescription Use | X |
|----------------------|---|
| (per 21 CFR 801.109) | |
AND/OR
| Over-The Counter Use | |
|----------------------------|--|
| (per 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 Device Evaluation and Safety (OIVD)
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Division Sign-Off
Office of In Vitro Diagnostic Device
Evaluation and Safety
