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.

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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study details for the OSOM iFOB Test, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" in a formal, enumerated list with specific thresholds for each performance metric. However, we can infer the acceptance criteria from the study's design and the conclusions drawn about "reproducibility" and "substantial equivalence." The main inferred acceptance criteria revolve around achieving high agreement with expected results and with a predicate device.

Performance Metric	Inferred Acceptance Criteria (Based on Study Findings)	Reported Device Performance
Reproducibility - Overall Agreement	High overall agreement with expected results across multiple sites, operators, days, and reagent lots.	98.5% (95% CI: 97.4% - 99.0%) overall agreement with expected results.
Reproducibility - Positive Agreement	High positive agreement with expected positive results.	98.5% (95% CI: 96.4% - 99.3%) positive percent agreement.
Reproducibility - Negative Agreement	High negative agreement with expected negative results.	98.6% (95% CI: 96.0 - 99.5%) negative percent agreement.
Detection Level Confirmation	Confirmation of the stated detection level of 50 ng/mL.	The study confirmed the detection level of 50 ng/mL, with results showing negative for 0 and 37.5 ng/mL and positive for 50, 62.5, and 2000 ng/mL (with very few exceptions which are within the margin of error of expected results based on very high overall PPA and NPA).
Sensitivity to Hemoglobin Variants	Detection of key hemoglobin variants (e.g., HbS, HbC) at or above the detection level.	All hHBS and hHbC samples at 50, 100, and 2,000 ng/mL were positive, indicating detection at concentrations of 50 ng/mL and higher.
Hook Effect	No hook effect at elevated hemoglobin levels.	Results for all samples with elevated hHbA, hHbS, and hHbC (2,000 ng/mL) were positive, demonstrating no hook effect at this level.
Method Comparison - Overall Agreement	High overall agreement with the predicate device (QuickVue iFOB Test).	99.2% (95% CI: 96.0 - 99.5%) overall agreement with QuickVue.
Method Comparison - Positive Agreement	High positive agreement with the predicate device.	100% (95% CI: 95.1 - 100.0%) positive agreement with QuickVue.
Method Comparison - Negative Agreement	High negative agreement with the predicate device.	98.0% (95% CI: 89.5 - 99.6%) negative agreement with QuickVue.
Cross-Reactivity	No cross-reactivity with specified non-human hemoglobins, myoglobins, or meat extracts.	All test results were negative for all listed potential cross-reactants (human Mb, sheep Hb, horse Hb, bovine Hb, porcine Hb, chicken Hb, rabbit Hb, fish Hb, goat Hb, horse Mb, and various meat extracts), indicating no cross-reactivity.
Interfering Substances	No interference from specified substances typically found in feces, both in negative and positive samples.	No interference was observed for any of the listed potential interferents (Horseradish Peroxidase, Broccoli, Turnip, Parsnip, Cauliflower, Cantaloupe, Red radish, Vitamin C, Iron), with negative samples remaining negative and positive samples (50 ng/mL hHbA) remaining positive.

2. Sample Size Used for the Test Set and Data Provenance

Reproducibility and Detection Limit Study:
- Sample Size: 542 individual test results were reported (325 expected positive, 217 expected negative). This was composed of panels of 15 test samples (3 of each of 5 hemoglobin concentrations: 0, 37.5, 50, 62.5, and 2000 ng/mL hHbA). Each POL operator tested 1 panel on each of 3 lots of the device. The reference site tested the same number of samples as the three external sites. Given 3 POL sites * 3 operators/site * 1 panel/operator/lot * 3 lots = 27 panels. The reference site also tested an equivalent amount. The specific number of unique samples is not directly stated, but the total number of test repetitions is 542.
- Data Provenance: Retrospective, using spiked fecal samples with known concentrations of human hemoglobin A. The samples are prepared specifically for the study.
Method Comparison Study:
- Sample Size: 125 individual test results (75 expected positive, 50 expected negative based on predicate device). This involved 25 replicates of each of the five hemoglobin concentrations (0, 37.5, 50, 62.5, and 2,000 ng/mL hHbA).
- Data Provenance: Retrospective, using spiked fecal samples with known concentrations of human hemoglobin A. The samples are prepared specifically for the study.
Sensitivity to Hemoglobin Variants, Hook Effect, Cross-Reactivity, and Interfering Substances:
- Sample Size: Specific numbers of discrete samples are not explicitly provided for these studies, but they involve testing various concentrations of hHbS, hHbC, potential cross-reactants, and interfering substances with three lots of the OSOM iFOB Test.
- Data Provenance: Retrospective, using prepared samples (spiked with specific substances) rather than naturally occurring patient samples.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Number of Experts: For the reproducibility study, expert oversight established the testing protocol. However, the ground truth for spiked samples is determined by the known concentration of human hemoglobin A added to the fecal samples, not through expert reading of results.
- Reproducibility study: "Testing at Sekisui Diagnostics, the reference site, was performed by two experienced laboratory professionals." These professionals performed the testing, but the ground truth (expected positive/negative) was based on the known spiked hemoglobin concentrations. The "intended users" at external POL sites also performed testing, with varying levels of education and work experience.
- Method Comparison study: The "ground truth" for the OSOM iFOB Test was effectively established by direct comparison to the predicate device (Alfa Instant-View FOB Rapid Test / QuickVue iFOB Test) which itself is cleared as substantially equivalent. The ground truth for the spiked samples themselves was the known hemoglobin concentration.
Qualifications of Experts: For the Sekisui Diagnostics reference site, "two experienced laboratory professionals" are mentioned. For the external POL sites, it stated "3 intended users per site, with varying levels of education and work experience," implying they are general laboratory or physician office personnel, not necessarily "experts" in establishing ground truth, but rather representative end-users.

4. Adjudication Method for the Test Set

The concept of "adjudication" in the sense of multiple external experts reviewing results to establish a definitive ground truth is not applicable here.

For the reproducibility and detection limit studies, the ground truth was analytically determined by the known concentrations of spiked human hemoglobin. Samples with 0 and 37.5 ng/mL were expected negative, and samples with 50, 62.5, and 2000 ng/mL were expected positive, based on the device's stated detection level of 50 ng/mL. Any discrepancies between the device result and this analytically derived "expected" result were simply tallied for agreement calculation.
For the method comparison study, the "ground truth" for comparison was the result obtained by the predicate device (QuickVue iFOB Test) on the same spiked samples, with the ultimate ground truth being the known spiked concentrations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study comparing human readers with AI assistance versus without AI assistance was not done.

This device (OSOM iFOB Test) is a lateral flow immunoassay for detecting occult blood, not an AI-powered diagnostic system that assists human readers in interpreting complex medical images or data. The "readers" mentioned in the reproducibility study (POL operators) are simply the end-users performing the physical test, not interpreting an AI output.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

Yes, the performance studies primarily reflect the standalone performance of the device.

The OSOM iFOB Test itself is a rapid immunoassay that produces a visible result (lines on a test strip). While a human operator (the "intended user" or "laboratory professional") has to perform the steps and visually interpret the lines, the core mechanism and output are inherent to the device's chemical and immunochromatographic properties. The studies evaluate the device's ability to accurately provide this result in various conditions, independent of active "human-in-the-loop" interpretive assistance beyond basic observation. The reproducibility study explicitly tested the ability of different users to get consistent results, which is a test of the device's robustness across user variability rather than a human-machine interface evaluation.

7. The Type of Ground Truth Used

The ground truth for all performance studies was primarily analytically determined via known concentrations of spiked human hemoglobin.

For the reproducibility, detection limit, sensitivity to variants, and hook effect studies, the ground truth was the known concentration of hemoglobin (hHbA, hHbS, hHbC) added to the fecal samples, which then dictated the expected positive or negative result based on the device's detection threshold.
For the cross-reactivity and interfering substances studies, the ground truth was the known absence or presence of specific interfering/cross-reacting substances along with, for interference, the known presence of hHbA at a critical concentration.
For the method comparison study, the ground truth was a combination of the known spiked hemoglobin concentrations and the results from a legally marketed predicate device (Alfa Instant-View FOB Rapid Test / QuickVue iFOB Test).

8. The Sample Size for the Training Set

The document does not describe a "training set" in the context of an algorithm or machine learning device.

The OSOM iFOB Test is an immunochromatographic assay, not a device that employs algorithms that require training data. The development of the test (e.g., antibody selection, membrane optimization) would have involved extensive R&D, but this is not typically referred to as a "training set" in the sense used for AI/ML.

9. How the Ground Truth for the Training Set Was Established

As there is no "training set" in the context of AI/ML, this question is not applicable. The device's underlying chemistry and biology are its "rules," not a learned algorithm.

Summary

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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:

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

1 1

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5. Intended Use

б. Comparison to Predicate Device

The Table below provides a summary of the device characteristics for the OSOM iFOB Test and the predicate device.

DeviceCharacteristics	OSOM iFOB Test[New Device]	Alfa Instant-View FOB RapidTest[Predicate/ K021423]
Intended Use	A rapid immunoassay for thequalitative detection of fecal occultblood by laboratories orphysicians' offices. It is useful forthe detection of humanhemoglobin in human fecalsamples and is recommended foruse as part of routine physicalexaminations or when lowergastrointestinal disorders aresuspected.	An immunochemical deviceintended for the qualitativedetection of Fecal Occult Blood bylaboratories or physicians' offices.It is useful in determininggastrointestinal (GI) bleedingfound in a number of GI disorders,such as diverticulitis, colitis,polyps, and colorectal cancer.Recommended for use in routinephysical examinations, hospitalmonitoring for bleeding patients,and screening for colorectal canceror GI bleeding from any source.
Specificallydetecting:	QualitativeHuman hemoglobin (hHb)	QualitativeHuman hemoglobin
Specimen	Human fecal specimen	Human fecal specimen
Detection Level	50 ng hHb/mL	50 ng hHb/mL
Assay Method	Immunochromatographicmembrane assay	Immunochromatographicmembrane assay
Result Format	Negative: Visible red Control line	Negative: Single visible burgundyline

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 lineand visible blue Test line	Positive: 2 visible burgundy lines
Antibodies	Capture: Goat polyclonal anti-hHbDetection: Monoclonal mouse anti-hHb conjugated to blue latex	Capture: Anti-hHb antibodiesDetection: Monoclonal mouse anti-hHb conjugated to colloidal gold
Internal Control	Visible red Control line	Visible burgundy line
External Controls	Negative: Buffer solutionPositive: hHb in buffer solutionProvided separately	Negative: Buffer solutionPositive: hHb in buffer solutionProvided separately
Sample Collectionand Transport	Provided applicator stick is used tocollect a small portion of feces andapply to sample collection card.Dry card is transported in mailing envelope	Provided grooved samplecollection probe is used to collectfecal sample, which is inserted inbuffer tube.Buffer tube is transported inmailing 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	NegativeSample Results	PositiveSample Results
Horseradish Peroxidase,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)

N28NIZarampm"

Division Sign-Off

Office of In Vitro Diagnostic Device

Evaluation and Safety

Regulation Number and Section

§ 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.