(294 days)
Not Found
No
The summary describes a fluorescence immunochromatographic assay system and a reader, which are standard laboratory technologies. There is no mention of AI, ML, or image processing that would suggest the use of such technologies. The performance studies focus on analytical and clinical agreement with a predicate device, not on the performance of an AI/ML algorithm.
No.
A therapeutic device is used for treatment or therapy, whereas this device is an in vitro diagnostic test for detecting fecal occult blood for diagnostic purposes.
Yes
The "Intended Use / Indications for Use" section explicitly states that "i-CHROMA iFOB ... is a fluorescence immuno-chromatographic assay system for qualitative detection of fecal occult blood (FOB) in human fecal samples" and "is an in vitro diagnostic test used by laboratories and physician offices for routine physical examination when gastrointestinal bleeding may be suspected." This clearly indicates its role in diagnosing a condition.
No
The device description explicitly states it is a "fluorescence immuno-chromatographic assay system" and is used "in conjunction with i-CHROMA Reader," indicating it includes both a physical assay component and a reader device, not just software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: Explicitly states "i-CHROMA iFOB is an in vitro diagnostic test".
- Device Description: Describes a system for detecting a substance (fecal occult blood) in a human sample (fecal samples) using an assay system. This is a hallmark of an in vitro diagnostic.
- Intended User/Care Setting: Mentions "laboratories and physician offices," which are typical settings where IVD tests are performed.
N/A
Intended Use / Indications for Use
i-CHROMA iFOB in conjunction with i-CHROMA Reader is a fluorescence immunochromatographic assay system for qualitative detection of fecal occult blood (FOB) in human fecal samples.
i-CHROMA iFOB is an in vitro diagnostic test used by laboratories and physician offices for routine physical examination when gastrointestinal bleeding may be suspected.
Product codes (comma separated list FDA assigned to the subject device)
OOX, JJX
Device Description
i-CHROMA iFOB in conjunction with i-CHROMA Reader is a fluorescence immunochromatographic assay system for qualitative detection of fecal occult blood (FOB) in human fecal samples.
Components of i-CHROMA iFOB:
i-CHROMA iFOB consists of a 'Test Cartridge', an 'ID Chip' and a 'Sample Collection Tube' containing the 'Detection Buffer' and i-CHROMA Reader
- The test cartridge contains a test strip; on the nitrocellulose membrane of which, murine antibodies against human hemoglobin and rabbit immunoglobulin-G have been immobilized at the test line and the control line respectively. Each test cartridge is individually sealed in an aluminum foil pouch containing a desiccant. 25 sealed test cartridges are packed in a box which also contains an ID chip.
- The detection buffer contains fluorochrome-labeled anti-human hemoglobin antibodies, fluorochrome-labeled anti-rabbit immunoglobulin-G, bovine serum albumin (BSA) as a stabilizer, and sodium azide in phosphate buffered saline (PBS) as a preservative. Each sample collection tube contains 1 mL detection buffer. 25 pre-filled sample collection tubes are packed in a box which is further packed in a Styrofoam box provided with ice packs for the purpose of shipment.
- Additionally, 'Patient Packs' are provided along with the test cartridge box and also separately on demand.
Each 'Patient Pack' contains following items:
- 1 Patient Instructions Leaflet (for sampling instructions)
- 1 Sample Collection Paper (for fixing onto the toilet bowl)
- 1 Sample Sac (for enclosing the sample collection tube after sampling)
- 1 Return Envelop (for submitting the sample collection tube to the laboratory/physician office for testing)
- i-CHROMA Reader is a fluorometer instrument which scans the sample-loaded . i-CHROMA iFOB test cartridge and displays the test result. i-CHROMA Reader and i-CHROMA iFOB are compatible only with each other. i-CHROMA Reader is marketed/supplied separately on demand.
- The ID chip contains a memory device that contains encoded calibration l data/information for the batch-to-batch (lot-to-lot) variation. With the ID chip inserted in the designated port, i-CHROMA Reader reads and utilizes the calibration data regarding the batch/lot under consideration and applies appropriate correction to the conversion formula while computing the test result.
i-CHROMA iFOB Test Cartridge:
i-CHROMA iFOB Test Cartridge is composed of a test strip enclosed in a disposable plastic housing.
The components of the test strip are:
- An antibody-immobilized nitrocellulose membrane -
- . A sample pad
- An absorption pad (also called absorbing pad or absorbent pad) -
- A plastic backing
i-CHROMA iFOB Sample Collection Tube:
'Sample Collection Tube' is an essential component of i-CHROMA iFOB. A box containing 25 pre-filled sample collection tubes, is delivered separately from the test cartridge box. It is further packed in a Styrofoam box provided with ice packs for the purpose of shipment.
The sample collection tube is a specially designed plastic container. Each sample collection tube contains 1mL Detection Buffer. Apart from being the container for the detection buffer, the sample collection tube serves the following purposes:
- Proper sampling of the fecal sample i)
- ii) Thorough mixing of the fecal sample with the detection buffer for ensuring complete extraction of the fecal sample
- iii) Application of precise quantity of the sample mixture into the 'Sample well' of the i-CHROMA iFOB test cartridge
i-CHROMA iFOB Sample Collection Tube' contains 1 mL 'Detection Buffer'. Approximately 13 mg (±1.82 mg) of human fecal sample is actually delivered into the detection buffer in the 'i-CHROMA iFOB Sample Collection Tube' following the sampling procedure described in the package insert of i-CHROMA iFOB test.
i-CHROMA Reader:
i-CHROMA Reader is a custom-configured, portable, desktop, fluorescence-scanning instrument for qualitative detection of fecal occult blood (FOB) in human fecal samples; duly mixed with the detection buffer and tested by i-CHROMA iFOB.
i-CHROMA Reader is intended to be used only in conjunction with i-CHROMA iFOB for in vitro diagnostic purpose by laboratories and physician offices. i-CHROMA Reader measures 250 mm (L) x 185 mm (W) x 80 mm (H) in size and weighs 1.2 Kg.
The i-CHROMA iFOB test cartridge is loaded with the human fecal sample which has been duly mixed with the detection buffer in i-CHROMA iFOB Sample Collection Tube as per the standard test procedure recommended by Boditech Med Inc. This sample loaded test cartridge is inserted in to the cartridge holder of the i-CHROMA Reader for the purpose of being scanned.
Upon inserting the sample-loaded test cartridge in the i-CHROMA Reader, the laser light illuminates the test cartridge membrane thereby triggering fluorescence from the fluorochrome-labeled complexes accumulated at the test line as well at the control line.
The fluorescent light is collected together with the scattered laser light. Pure fluorescence is filtered from the mixture of the scattered and fluorescent light. Intensity of the fluorescence is scanned and converted into an electric signal which correlates to the intensity of fluorescence and hence to the concentration of FOB hemoglobin in the test sample.
The on-board microprocessor computes the FOB hemoglobin concentration based on a pre-programmed calibration. The computed and converted result is displayed by the i-CHROMA Reader in a qualitative (positive or negative) manner.
Test Principle:
i-CHROMA iFOB is an immunoassay system based on antigen-antibody reaction and fluorescence technology.
When a human fecal sample is mixed with the detection buffer in the sample collection tube, the fluorochrome-labeled detector antibodies (anti-hemoglobin) in the detection buffer binds with hemoglobin in the fecal occult blood (FOB).
When the fecal sample mixture is loaded into the sample well on the test cartridge as per the recommended test procedure, it migrates through the nitrocellulose matrix of the test strip.
The fluorochrome-labeled detector antibody-analyte (FOB hemoglobin) complexes get captured on to the capture antibodies (anti-hemoglobin) which have been immobilized at the test line on the test strip.
As a result, the fluorochrome-labeled complexes of the detector antibody-analyte (FOB hemoglobin)-capture antibody get accumulated at the test line on test cartridge membrane.
Thus, more the hemoglobin in the human fecal sample, more the complexes that get accumulated at the test line on the test cartridge membrane.
Upon inserting the sample-loaded test cartridge in the i-CHROMA iFOB Reader, the laser light illuminates the test cartridge membrane thereby triggering fluorescence from the fluorochrome-labeled complexes of hemoglobin.
The fluorescent light is collected together with the scattered laser light. Pure fluorescence is filtered from the mixture of the scattered and fluorescent light. Intensity of the fluorescence is scanned and converted into an electric signal which is correlates to the intensity of fluorescence and hence to the concentration of FOB hemoglobin in the test sample.
The on-board microprocessor computes the FOB hemoglobin concentration based on a pre-programmed calibration.
The computed and converted result is displayed by the i-CHROMA Reader in a qualitative (positive or negative) manner based on an analytical cut-off of 100 ng/mL (hemoglobin in fecal sample mixed with detection buffer) which is equivalent to 8ug i.e. 0.008 mg hemoglobin per gram of stool.
i-CHROMA iFOB and i-CHROMA Reader are compatible only with each other.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
laboratories and physician offices
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)
Summary of Performance Testing (Bench):
- A i-CHROMA iFOB showed no prozone/hook effect up to analyte concentration 2000 ng/mL.
- i-CHROMA iFOB was found to be equally sensitive to 'Hemoglobin S' as the abnormal hemoglobin associated with sickle cell anemia.
- i-CHROMA iFOB showed no significant cross-reactivity with any of the eight animal hemoglobin (i.e. bovine, chicken, fish, horse/equine, goat, pig/swine, rabbit, and sheep origin) and no significant interference from any of the four endogenous substances (Ascorbic acid, Bilirubin, Albumin and Myoglobin).
- i-CHROMA iFOB showed high degree of repeatability as well as between-run, lot-to-lot, instrument-to-instrument and site-site reproducibility.
- Analytical method comparison study at three US sites performed on spiked human fecal samples showed high degree of overall percent agreement as well as positive percent agreement and negative percent agreement between test results obtained with i-CHROMA iFOB and the predicate method OC Auto Micro FOB.
- Clinical testing study at two Korean and one US site involving prospective testing of clinical human fecal samples showed:
- More than 96% positive and negative percent agreements in test results when compared with the predicate method OC Auto Micro FOB.
- 95-99.66% accuracy in test results with weak positive and weak negative samples.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
More than 96% positive and negative percent agreements
95-99.66% accuracy
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Section 5: 510(k) SUMMARY
MAY 0 2 2014
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21CFR, Section 807.92 (c).
Submitter Information: Boditech Med Inc. 43, Geodudanji 1-gil, Dongnae-myeon, Chuncheon-si, Gang-won-do, 200-883, REPUBLIC OF KOREA. Phone No.: +82 33 243 1400 Fax No.: +82 33 243 9373 E-mail: psy@boditech.co.kr Website: www.boditech.co.kr
Contact Person:
Sang Yeol Park/ Senior Director/ Ph.D.
Date:
March 03, 2014
Device Information:
| Trade Name: | i-CHROMA iFOB with i-CHROMA Reader |
|---|---|
| Common Name: | i-CHROMA iFOB |
| Classification Name: | Automated Occult Blood Analyzer |
| Class: | II |
| Panel: | Hematology |
| Product Code: | OOX |
| Regulation: | 21 CFR § 864.6550 |
Predicate Device: OC Auto Micro FOB Test and Polymedco OC Auto Micro 80 Analyzer Predicate K Number: K041408
Device Description:
i-CHROMA iFOB in conjunction with i-CHROMA Reader is a fluorescence immunochromatographic assay system for qualitative detection of fecal occult blood (FOB) in human fecal samples.
Intended Use(s):
i-CHROMA iFOB in conjunction with i-CHROMA Reader is a fluorescence immunochromatographic assay system for qualitative detection of fecal occult blood (FOB) in human fecal samples. i-CHROMA iFOB is an in vitro diagnostic test used by laboratories and physician offices for routine physical examination when gastrointestinal bleeding may be suspected.
1
Indications for Use(s):
i-CHROMA iFOB is an in vitro diagnostic test used by laboratories and physician offices for routine physical examination when gastrointestinal bleeding may be suspected.
Components of i-CHROMA iFOB:
i-CHROMA iFOB consists of a 'Test Cartridge', an 'ID Chip' and a 'Sample Collection Tube' containing the 'Detection Buffer' and i-CHROMA Reader
- The test cartridge contains a test strip; on the nitrocellulose membrane of which, murine antibodies against human hemoglobin and rabbit immunoglobulin-G have been immobilized at the test line and the control line respectively. Each test cartridge is individually sealed in an aluminum foil pouch containing a desiccant. 25 sealed test cartridges are packed in a box which also contains an ID chip.
- -The detection buffer contains fluorochrome-labeled anti-human hemoglobin antibodies, fluorochrome-labeled anti-rabbit immunoglobulin-G, bovine serum albumin (BSA) as a stabilizer, and sodium azide in phosphate buffered saline (PBS) as a preservative. Each sample collection tube contains 1 mL detection buffer. 25 pre-filled sample collection tubes are packed in a box which is further packed in a Styrofoam box provided with ice packs for the purpose of shipment.
- Additionally, 'Patient Packs' are provided along with the test cartridge box and also separately on demand.
Each 'Patient Pack' contains following items:
- = 1 Patient Instructions Leaflet (for sampling instructions)
- · 1 Sample Collection Paper (for fixing onto the toilet bowl)
- · 1 Sample Sac (for enclosing the sample collection tube after sampling)
- · 1 Return Envelop (for submitting the sample collection tube to the laboratory/physician office for testing)
- i-CHROMA Reader is a fluorometer instrument which scans the sample-loaded . i-CHROMA iFOB test cartridge and displays the test result. i-CHROMA Reader and i-CHROMA iFOB are compatible only with each other. i-CHROMA Reader is marketed/supplied separately on demand.
- The ID chip contains a memory device that contains encoded calibration l data/information for the batch-to-batch (lot-to-lot) variation. With the ID chip inserted in the designated port, i-CHROMA Reader reads and utilizes the calibration data regarding the batch/lot under consideration and applies appropriate correction to the conversion formula while computing the test result.
2
i-CHROMA iFOB Test Cartridge:
i-CHROMA iFOB Test Cartridge is composed of a test strip enclosed in a disposable plastic housing.
The components of the test strip are:
- An antibody-immobilized nitrocellulose membrane -
- . A sample pad
- An absorption pad (also called absorbing pad or absorbent pad) -
- A plastic backing 1
i-CHROMA iFOB Sample Collection Tube:
'Sample Collection Tube' is an essential component of i-CHROMA iFOB. A box containing 25 pre-filled sample collection tubes, is delivered separately from the test cartridge box. It is further packed in a Styrofoam box provided with ice packs for the purpose of shipment.
The sample collection tube is a specially designed plastic container. Each sample collection tube contains 1mL Detection Buffer. Apart from being the container for the detection buffer, the sample collection tube serves the following purposes:
- Proper sampling of the fecal sample i)
- ii) Thorough mixing of the fecal sample with the detection buffer for ensuring complete extraction of the fecal sample
- iii) Application of precise quantity of the sample mixture into the 'Sample well' of the i-CHROMA iFOB test cartridge
i-CHROMA iFOB Sample Collection Tube' contains 1 mL 'Detection Buffer'. Approximately 13 mg (±1.82 mg) of human fecal sample is actually delivered into the detection buffer in the 'i-CHROMA iFOB Sample Collection Tube' following the sampling procedure described in the package insert of i-CHROMA iFOB test.
i-CHROMA Reader:
i-CHROMA Reader is a custom-configured, portable, desktop, fluorescence-scanning instrument for qualitative detection of fecal occult blood (FOB) in human fecal samples; duly mixed with the detection buffer and tested by i-CHROMA iFOB.
i-CHROMA Reader is intended to be used only in conjunction with i-CHROMA iFOB for in vitro diagnostic purpose by laboratories and physician offices. i-CHROMA Reader measures 250 mm (L) x 185 mm (W) x 80 mm (H) in size and weighs 1.2 Kg.
The i-CHROMA iFOB test cartridge is loaded with the human fecal sample which has been duly mixed with the detection buffer in i-CHROMA iFOB Sample Collection Tube as per the standard test procedure recommended by Boditech Med Inc. This sample
3
loaded test cartridge is inserted in to the cartridge holder of the i-CHROMA Reader for the purpose of being scanned.
Upon inserting the sample-loaded test cartridge in the i-CHROMA Reader, the laser light illuminates the test cartridge membrane thereby triggering fluorescence from the fluorochrome-labeled complexes accumulated at the test line as well at the control line.
The fluorescent light is collected together with the scattered laser light. Pure fluorescence is filtered from the mixture of the scattered and fluorescent light. Intensity of the fluorescence is scanned and converted into an electric signal which correlates to the intensity of fluorescence and hence to the concentration of FOB hemoglobin in the test sample.
The on-board microprocessor computes the FOB hemoglobin concentration based on a pre-programmed calibration. The computed and converted result is displayed by the i-CHROMA Reader in a qualitative (positive or negative) manner.
Test Principle:
i-CHROMA iFOB is an immunoassay system based on antigen-antibody reaction and fluorescence technology.
When a human fecal sample is mixed with the detection buffer in the sample collection tube, the fluorochrome-labeled detector antibodies (anti-hemoglobin) in the detection buffer binds with hemoglobin in the fecal occult blood (FOB).
When the fecal sample mixture is loaded into the sample well on the test cartridge as per the recommended test procedure, it migrates through the nitrocellulose matrix of the test strip.
The fluorochrome-labeled detector antibody-analyte (FOB hemoglobin) complexes get captured on to the capture antibodies (anti-hemoglobin) which have been immobilized at the test line on the test strip.
As a result, the fluorochrome-labeled complexes of the detector antibody-analyte (FOB hemoglobin)-capture antibody get accumulated at the test line on test cartridge membrane.
Thus, more the hemoglobin in the human fecal sample, more the complexes that get accumulated at the test line on the test cartridge membrane.
Upon inserting the sample-loaded test cartridge in the i-CHROMA Reader, the laser light illuminates the test cartridge membrane thereby triggering fluorescence from the fluorochrome-labeled complexes of hemoglobin.
The fluorescent light is collected together with the scattered laser light. Pure fluorescence is filtered from the mixture of the scattered and fluorescent light. Intensity of the fluorescence is scanned and converted into an electric signal which is correlates to the intensity of fluorescence and hence to the concentration of FOB hemoglobin in the test sample.
4
The on-board microprocessor computes the FOB hemoglobin concentration based on a pre-programmed calibration.
The computed and converted result is displayed by the i-CHROMA Reader in a qualitative (positive or negative) manner based on an analytical cut-off of 100 ng/mL (hemoglobin in fecal sample mixed with detection buffer) which is equivalent to 8ug i.e. 0.008 mg hemoglobin per gram of stool.
i-CHROMA iFOB and i-CHROMA Reader are compatible only with each other.
Substantial Equivalence Information:
Predicate Device: OC Auto Micro FOB Test and Polymedco OC Auto Micro 80 Analyzer
Predicate K Number: K041408
Comparison with the Predicate Device:
Following table summarizes similarities and difference between the test device i-CHROMA iFOB and the predicate device OC Auto Micro FOB Test.
| SIMILARITIES | |||
|---|---|---|---|
| No. | Comparison | ||
| Parameter | Test Device | ||
| (i-CHROMA iFOB with | |||
| i-CHROMA Reader) | Predicate Device | ||
| (OC Auto Micro FOB Test with | |||
| Polymedco OC Auto Micro 80 | |||
| Analyzer) | |||
| 1 | Test Principle | Immunological test system using | |
| antigen-antibody reaction for detection | |||
| of human hemoglobin in human fecal | |||
| samples. | Immunological test system intended | ||
| for qualitative detection of fecal | |||
| occult blood in feces | |||
| 2 | Intended Use | Qualitative detection of fecal occult | |
| blood (FOB) in human fecal samples | |||
| by laboratories and physician offices | Qualitative detection of fecal occult | ||
| blood in feces by professional | |||
| laboratories | |||
| 3 | Test Sample | Human fecal sample mixed with | |
| detection buffer in the sample | |||
| collection tube | Feces in an extraction buffer | ||
| 4 | Test Cut-off | 100 ng/mL (Human hemoglobin in | |
| human fecal sample mixed with | |||
| detection buffer) | 100 ng/mL (Human hemoglobin in | ||
| feces processed in extraction buffer) | |||
| DIFFERENCES | |||
| No. | Comparison | ||
| Parameter | Test Device | ||
| (i-CHROMA iFOB with | |||
| i-CHROMA Reader) | Predicate Device | ||
| (OC Auto Micro FOB Test with | |||
| Polymedco OC Auto Micro 80 | |||
| Analyzer) | |||
| 1 | Test Platform | Fluorescence immunoassay using | |
| lateral flow technology | Automated immunoassay using latex | ||
| fixation | |||
| 2 | Test Time | 10 minutes | 5-10 minutes |
5
| 3 | Detection Mechanism | Involves scanning/measurement of intensity of fluorescence on the test cartridge membrane | Involves optical measurement of agglutination of latex particles |
|---|---|---|---|
| ---------- | --------------------- | ------------------------------------------------------------------------------------------- | ------------------------------------------------------------------ |
Standard/Guidance Document Referenced:
USFDA guidance document for industry and FDA staff:
'Review Criteria for Assessment of Qualitative Fecal Occult Blood In Vitro Diagnostic Devices' (Issue date: August 8, 2007)
Summary of Performance Testing (Bench):
- A i-CHROMA iFOB showed no prozone/hook effect up to analyte concentration 2000 ng/mL.
-
i-CHROMA iFOB was found to be equally sensitive to 'Hemoglobin S' as the abnormal hemoglobin associated with sickle cell anemia.
-
i-CHROMA iFOB showed no significant cross-reactivity with any of the eight animal hemoglobin (i.e. bovine, chicken, fish, horse/equine, goat, pig/swine, rabbit, and sheep origin) and no significant interference from any of the four endogenous substances (Ascorbic acid, Bilirubin, Albumin and Myoglobin).
-
i-CHROMA iFOB showed high degree of repeatability as well as between-run, lot-to-lot, instrument-to-instrument and site-site reproducibility.
-
Analytical method comparison study at three US sites performed on spiked human fecal samples showed high degree of overall percent agreement as well as positive percent agreement and negative percent agreement between test results obtained with i-CHROMA iFOB and the predicate method OC Auto Micro FOB.
-
Clinical testing study at two Korean and one US site involving prospective testing of clinical human fecal samples showed:
- " More than 96% positive and negative percent agreements in test results when compared with the predicate method OC Auto Micro FOB.
- " 95-99.66% accuracy in test results with weak positive and weak negative samples.
6
Image /page/6/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the circumference of the circle. The logo is presented in black and white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 2, 2014
Boditech Med Inc. c/o Sang Yoel Park, Ph.D., Senior Director QA & RA 43, Geodudanji I-gil, Dongnae-myeon Chuncheon-si, Gang-won-do, 200-883 REPUBLIC OF KOREA
Re: K132167
Trade/Device Name: i-CHROMA iFOB with i-CHROMA Reader i-CHROMA iFOB Controls Regulation Number: 21 CFR 864.6550 Regulation Name: Occult Blood Test Regulatory Class: Class II Product Code: OOX, JJX Dated: April 23, 2014 Received: April 25, 2014
Dear Dr. Park:
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, howcver, that device labeling must be truthful and not misleading.
If your device is classified (sec 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 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
7
Page 2 - Sang Yoel Park, Ph.D.
forth in the quality systems (OS) 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 contact the Division of Industry and Consumer Education 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. 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/ReportaProblem/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 Industry and Consumer Education 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,
Maria M. Chan -S
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
8
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K132167
Device Name
i-CHROMA iFOB Controls
Indications for Use (Describe)
i-CHROMA iFOB Controls are external quality control reagents intended for monitoring acceptable performance of i-CHROMA iFOB test system which is a qualitative in-vitro diagnostic test for detection of fecal occult blood having an analytical cut-off of 100 ng/mL which is equivalent to 8ug i.e. 0.008 mg hemoglobin per gram of stool.
Type of Use (Select one or both, as applicable)
[x] Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 807 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Maria M. Chan -S
FORM FDA 3881 (6/13)
Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.
9
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.
510(k) Number (if known) K132167
Device Name
i-CHROMA iFOB with i-CHROMA Reader
Indications for Use (Describe)
i-CHROMA iFOB in conjunction with i-CHROMA Reader is a fluorescence immuno-chromatographic assay system for qualitative detection of fecal occult blood (FOB) in human fecal samples.
i-CHROMA iFOB is an in vitro diagnostic test used by laboratories and physician offices for routine physical examination when gastrointestinal bleeding may be suspected.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 807 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Maria M. Chan -S
FORM FDA 3881 (6/13)