(60 days)
Not Found
No
The device description and performance studies focus on chemical reagents and standard analytical methods for quantitative determination of bilirubin, with no mention of AI or ML.
No
This device is an in vitro diagnostic (IVD) reagent intended for the quantitative determination of bilirubin levels, which are used in the diagnosis of liver, hematological, and metabolic disorders. It does not provide any therapeutic function.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "intended for the quantitative in vitro diagnostic determination of total bilirubin in human serum and plasma," and that "Measurements of the levels of bilirubin...are used in the diagnosis and treatment of liver, hematological, and metabolic disorders." This clearly indicates its diagnostic purpose.
No
The device is a kit consisting of chemical reagents intended for in vitro diagnostic testing, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states:
- "ELITech Clinical Systems BILIRUBIN TOTAL 4+1 is intended for the quantitative in vitro diagnostic determination of total bilirubin in human serum and plasma..."
- "ELITech Clinical Systems BILIRUBIN DIRECT 4+1 is intended for the quantitative in vitro diagnostic determination of direct bilirubin in human serum and plasma..."
This language clearly indicates that the device is designed to be used outside of the body (in vitro) for diagnostic purposes.
N/A
Intended Use / Indications for Use
ELITech Clinical Systems BILIRUBIN TOTAL 4+1 is intended for the quantitative in vitro diagnostic determination of total bilirubin in human serum and plasma on ELITech Clinical Systems Selectra Pro Series Analyzers.
ELITech Clinical Systems BILIRUBIN DIRECT 4+1 is intended for the quantitative in vitro diagnostic determination of direct bilirubin in human serum and plasma on ELITech Clinical Systems Selectra Pro Series Analyzers.
It is not intended for use in Point of Care settings.
Measurements of the levels of bilirubin (direct or total), an organic compound formed during the normal and abnormal distruction of red blood cells, are used in the diagnosis and treatment of liver, hematological, and metabolic disorders, including hepatitis and gall bladder block.
Product codes (comma separated list FDA assigned to the subject device)
CIG
Device Description
Both ELITech Clinical Systems BILIRUBIN TOTAL 4+1 and ELITech Clinical Systems BILIRUBIN DIRECT 4+1 are available as a kit only.
Each kit consists of a bi-reagent R1 & R2 whose composition is:
ELITech Clinical Systems BILIRUBIN TOTAL 4+1 :
Reagent 1: R1
Sulphanilic acid 29 mmol/L,
Cetrimide 29 mmol/L.
Reagent 2: R2
Sodium nitrite 11 mmol/L.
ELITech Clinical Systems BILIRUBIN DIRECT 4+1 :
Reagent 1: R1
Sulphanilic acid 29 mmol/L,
Reagent 2: R2
Sodium nitrite 11 mmol/L.
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
Prescription Use (Part 21 CFR 801 Subpart D)
It is not intended for use in Point of Care settings.
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)
Precision/Reproducibility
For ELITech Clinical Systems BILIRUBIN TOTAL 4+1:
Within-run and total precision results were obtained by performing two runs per day, two measures per run, for 3 concentrations of samples on 2 instruments during twenty operating days.
Level 1: Mean (mg/dL) 1.15, Within-run CV% 1.8, Total CV% 5.0
Level 2: Mean (mg/dL) 4.08, Within-run CV% 0.4, Total CV% 3.1
Level 3: Mean (mg/dL) 14.61, Within-run CV% 0.5, Total CV% 2.9
For ELITech Clinical Systems BILIRUBIN DIRECT 4+1:
Within-run and total precision results were obtained by performing two runs per day, two measures per run, for 3 concentrations of samples on 2 instruments during twenty operating days.
Level 1: Mean (mg/dL) 0.36, Within-run CV% 3.8, Total CV% 5.2
Level 2: Mean (mg/dL) 1.51, Within-run CV% 1.9, Total CV% 5.3
Level 3: Mean (mg/dL) 3.99, Within-run CV% 0.9, Total CV% 4.7
Linearity/assay reportable range
ELITech Clinical Systems BILIRUBIN TOTAL 4+1:
Measuring range: 0.25 - 25 mg/dL.
Auto-dilution 1 to 5 allows use with analyte concentration up to 60.00 mg/dL.
ELITech Clinical Systems BILIRUBIN DIRECT 4+1:
Measuring range: 0.08 - 10.55 mg/dL.
Auto-dilution 1 to 5 allows use with analyte concentration up to 50.00 mg/dL.
Detection limit
ELITech Clinical Systems BILIRUBIN TOTAL 4+1:
Limit of Detection: 0.04 mg/dL (0.7 umol/L)
Limit of Quantification: 0.15 mq/dL (2.6 umol/L)
ELITech Clinical Systems BILIRUBIN DIRECT 4+1:
Limit of Detection: 0.01 mg/dL (0.2 umol/L)
Limit of Quantification: 0.08 mg/dL (1.4 µmol/L)
Interference/analytical specificity
ELITech Clinical Systems BILIRUBIN TOTAL 4+1:
Triglycerides: No significant interference up to 2100 mg/dL (23.73 mmol/L).
Hemoglobin: No significant interference up to 500 mg/dL.
Acetaminophen: No significant interference up to 30 mg/dL.
Ascorbic acid: No significant interference up to 4 mg/dL.
Acetylsalicylic acid: No significant interference up to 200 mg/dL.
In very rare cases, monoclonal gammopathies (multiple myeloma), in particular IgM type (Waldenstrom's macroglobulinemia) can cause unreliable results.
ELITech Clinical Systems BILIRUBIN DIRECT 4+1:
Triglycerides: No significant interference up to 2000 mg/dL (22.60 mmol/L)
Hemoglobin: No significant interference up to 125 mg/dL.
Acetaminophen: No significant interference up to 30 mg/dL.
Ascorbic acid: No significant interference up to 0.5 mg/dL.
Acetylsalicylic acid: No significant interference up to 200 mg/dL.
In very rare cases, monoclonal gammopathies (multiple myeloma), in particular IgM । type (Waldenstrom's macroglobulinemia) can cause unreliable results.
Method comparison
ELITech Clinical Systems BILIRUBIN TOTAL 4+1:
Study performed using 100 serum patient samples from 0.32 to 23.02 mg/dL.
Regression analysis: y = 0.948 x - 0.11 mg/dL. r = 0.999 r2 = 0.999 Standard error of the estimate Sy.x = 0.19 mg/dL.
ELITech Clinical Systems BILIRUBIN DIRECT 4+1:
Study performed using 100 serum patient samples from 0.09 to 10.52 mg/dL.
Regression analysis: y = 0.926 x - 0.03 mg/dL. r = 0.998 r2 = 0.995 Standard error of the estimate Sy.x = 0.15 mg/dL.
Comparison study: Matrix comparison
ELITech Clinical Systems BILIRUBIN TOTAL 4+1:
40 plasma patients (in lithium heparin samples, ranging from 0.33 to 24.08 mg/dL).
Regression analysis: y = 0.985x + 0.03 mg/dL r = 0.998 r2 = 0.997 Standard error of the estimate Sy.x = 0.36 mg/dL
ELITech Clinical Systems BILIRUBIN DIRECT 4+1:
40 plasma patients (in lithium heparin samples, ranging from 0.09 to 7.78 mg/dL).
Regression analysis: y = 0.990x - 0.01 mg/dL r = 0.999 r2 = 0.997 Standard error of the estimate Sy.x = 0.14 mg/dL
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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
§ 862.1110 Bilirubin (total or direct) test system.
(a)
Identification. A bilirubin (total or direct) test system is a device intended to measure the levels of bilirubin (total or direct) in plasma or serum. Measurements of the levels of bilirubin, an organic compound formed during the normal and abnormal distruction of red blood cells, if used in the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the circle is a stylized image of a caduceus, which is a symbol of medicine.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 11, 2017
ELITECHGROUP TERRY TRIMINGHAM, REGULATORY AFFAIRS MANAGER 21720 23RD DRIVE SE, SUITE 150 BOTHELL, WA 98021
Re: K171401 Trade/Device Name: ELITech Clinical Systems BILIRUBIN TOTAL 4+1, ELITech Clinical Systems BILIRUBIN DIRECT 4+1 Regulation Number: 21 CFR 862.1110 Regulation Name: Bilirubin (total or direct) test system Regulatory Class: II Product Code: CIG Dated: May 3, 2017 Received: May 12, 2017
Dear Terry Trimingham:
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 CFR Part 807); labeling (21 CFR Parts 801 and 809); 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.
1
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), 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" (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/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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Kellie B. Kelm -S
for Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K171401
Device Name
ELITech Clinical Systems BILIRUBIN TOTAL 4+1 ELITech Clinical Systems BILIRUBIN DIRECT 4+1
Indications for Use (Describe)
ELITech Clinical Systems BILIRUBIN TOTAL 4+1 is intended for the quantitative in vitro diagnostic determination of total bilirubin in human serum and plasma on ELITech Clinical Systems Selectra Pro Series Analyzers.
ELITech Clinical Systems BILIRUBIN DIRECT 4+1 is intended for the quantitative in vitro diagnostic determination of direct bilirubin in human serum and plasma on ELITech Clinical Systems Selectra Pro Series Analyzers.
It is not intended for use in Point of Care settings.
Measurements of the levels of bilirubin (direct or total), an organic compound formed during the normal and abnormal distruction of red blood cells, are used in the diagnosis and treatment of liver, hematological, and metabolic disorders, including hepatitis and gall bladder block.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
[X] Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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3
510(k) Summary
ELITech Clinical Systems BILIRUBIN TOTAL 4+1 ELITech Clinical Systems BILIRUBIN DIRECT 4+1
| 1. | Date: | July 11, 2017 |
|---|---|---|
| 2. | Submitter: | ELITech Clinical Systems SAS |
| Zone Industrielle | ||
| 61500 SEES | ||
| FRANCE | ||
| 3. | Contact Person: | Terry Trimingham |
| 21720 23rd Dr SE, Suite 150 | ||
| Bothell, WA 98021 | ||
| Phone: 425-482-5190 | ||
| Fax: 425-482-5550 | ||
| Email: t.trimingham@elitechgroup.com | ||
| 4. | Device Description: | ELITech Clinical Systems BILIRUBIN TOTAL 4+1 |
| Classification | Class II | |
| CIG - Diazo Colorimetry, Bilirubin | ||
| Clinical Chemistry | ||
| 21 CFR 862.1110 | ||
| Device Description: | ELITech Clinical Systems BILIRUBIN DIRECT 4+1 | |
| Classification | Class II | |
| CIG - Diazo Colorimetry, Bilirubin | ||
| Clinical Chemistry | ||
| 21 CFR 862.1110 | ||
| 5. | Predicate Device: | K060325 |
| ABX Pentra Bilirubin, Total CP | ||
| ABX Pentra Bilirubin, Direct CP |
4
| Intended Use | |
|---|---|
| ELITech Clinical | |
| Systems BILIRUBIN | |
| TOTAL 4+1: | ELITech Clinical Systems BILIRUBIN TOTAL 4+1 is |
| intended for the quantitative in vitro diagnostic | |
| determination of total bilirubin in human serum and | |
| plasma on ELITech Clinical Systems Selectra Pro Series | |
| Analyzers. |
Measurements of the levels of bilirubin (direct or total), an
organic compound formed during the normal and
abnormal distruction of red blood cells, are used in the
diagnosis and treatment of liver, hemolytic hematological,
and metabolic disorders, including hepatitis and gall
bladder block.
It is not intended for use in Point of Care settings. |
| ELITech Clinical
Systems BILIRUBIN
DIRECT 4+1: | ELITech Clinical Systems BILIRUBIN TOTAL 4+1 is
intended for the quantitative in vitro diagnostic
determination of total bilirubin in human serum and
plasma on ELITech Clinical Systems Selectra Pro Series
Analyzers.
Measurements of the levels of bilirubin (direct or total), an
organic compound formed during the normal and
abnormal distruction of red blood cells, are used in the
diagnosis and treatment of liver, hemolytic hematological,
and metabolic disorders, including hepatitis and gall
bladder block.
It is not intended for use in Point of Care settings. |
Special conditions for use statement(s):
Rx only.
This device is intended for prescription use and in vitro diagnostic only.
CAUTION: Federal Law restricts this device to sale by or on the order of a licensed healthcare practitioner. It is not intended for use in Point of Care settings.
Reagent Special instrument requirements:
For use with ELITech Clinical Systems Selectra Pro Series Analyzers. Performance data was obtained on the Selectra ProM Analyzer.
5
7. Device Descriptions
Both ELITech Clinical Systems BILIRUBIN TOTAL 4+1 and ELITech Clinical Systems BILIRUBIN DIRECT 4+1 are available as a kit only.
Each kit consists of a bi-reagent R1 & R2 whose composition is:
ELITech Clinical Systems BILIRUBIN TOTAL 4+1 :
Reagent 1: R1
Sulphanilic acid 29 mmol/L,
Cetrimide 29 mmol/L.
Reagent 2: R2
Sodium nitrite 11 mmol/L.
ELITech Clinical Systems BILIRUBIN DIRECT 4+1 :
Reagent 1: R1
Sulphanilic acid 29 mmol/L,
Reagent 2: R2
Sodium nitrite 11 mmol/L.
Substantial Equivalence Information
Assay (reagent)
-
- Predicate Device Name
ABX Pentra Bilirubin, Total CP & ABX Pentra Bilirubin, Direct CP
- Predicate Device Name
- Comparison with predicate ABX Pentra Bilirubin, Total CP & ABX Pentra Bilirubin, Direct CP
Similarities
| Similarities | ||
|---|---|---|
| Parameter | New Device | |
| ELITech Clinical Systems BILIRUBIN | ||
| TOTAL 4+1 & ELITech Clinical | ||
| Systems BILIRUBIN DIRECT 4+1 | Predicate Device | |
| ABX Pentra Bilirubin, Total CP & ABX | ||
| Pentra Bilirubin, Direct CP, K060325 | ||
| Intended Use | ELITech Clinical Systems | |
| BILIRUBIN TOTAL 4+1: | ABX Pentra Bilirubin, Total CP: | |
| ELITech Clinical Systems BILIRUBIN | ||
| TOTAL 4+1 is intended for the | ||
| quantitative in vitro diagnostic | ||
| determination of total bilirubin in | ||
| human serum and plasma on ELITech | ||
| Clinical Systems Selectra Pro Series | ||
| Analyzers. | ABX Pentra Bilirubin, Total CP reagent | |
| is intended for the quantitative in vitro | ||
| diagnostic determination of total | ||
| bilirubin in human serum and plasma | ||
| based on a photometric test using 2,4- | ||
| dichloroaniline (DCA) and detergents. | ||
| It is not intended for use in Point of | ||
| Care settings. |
6
| | ELITech Clinical Systems
BILIRUBIN DIRECT 4+1 : | ABX Pentra Bilirubin, Direct CP : |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | ELITech Clinical Systems BILIRUBIN
DIRECT 4+1 is intended for the
quantitative in vitro diagnostic
determination of direct bilirubin in
human serum and plasma on ELITech
Clinical Systems Selectra Pro Series
Analyzers. | ABX Pentra Bilirubin, Direct CP reagent
is intended for the quantitative in vitro
diagnostic determination of direct
bilirubin in human serum and plasma
based on a photometric test using 2,4-
dichloroaniline (DCA). |
| | It is not intended for use in Point of
Care settings. | |
| Indication for
Use | Measurements of the levels of bilirubin
(direct or total), an organic compound
formed during the normal and
abnormal destruction of red blood cells,
are used in the diagnosis and
treatment of liver, hemolytic
hematological, and metabolic
disorders, including hepatitis and gall
bladder block. It is not intended for use
in Point of Care settings. | Same |
| Sample Type | Serum, plasma | Same |
| Appearance
of reagents | Liquid form, ready to use | Same |
Differences
| Parameter | New Device
ELITech Clinical Systems BILIRUBIN
TOTAL 4+1 & ELITech Clinical
Systems BILIRUBIN DIRECT 4+1 | Predicate Device
ABX Pentra Bilirubin, Total CP & ABX
Pentra Bilirubin, Direct CP K060325 |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|
| Assay Format | ELITech Clinical Systems
BILIRUBIN TOTAL 4+1 :
R1: 8 x 20 mL
R2: 8 x 5 mL
ELITech Clinical Systems
BILIRUBIN DIRECT 4+1 :
R1: 8 x 20 mL
R2: 8 x 5 mL | ABX Pentra Bilirubin, Total CP :
R1 : 29.5 mL
R2 : 9.8 mL
ABX Pentra Bilirubin, Direct CP :
R1 : 24 mL
R2 : 7 mL |
| Assay
Technology | Malloy-Evelyn modified. End point. | Photometric test using 2,4-
dichloroaniline (DCA), and a specific
mixture of detergents. |
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8
| Reference
Values | ELITech Clinical Systems
BILIRUBIN TOTAL 4+1 : | ABX Pentra Bilirubin, Total CP : |
|-----------------------|------------------------------------------------------------------------------|----------------------------------------------------------------------------|
| | 0.2-1.2 mg/dL (3.4-21 µmol/L)
ELITech Clinical Systems | Adults: 0.1 - 1.2 mg/dL (1.7 - 21
µmol/L) |
| | BILIRUBIN DIRECT 4+1 : | ABX Pentra Bilirubin, Direct CP : |
| |