(8 days)
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No
The summary describes a chemical reagent and calibrator for a laboratory analyzer, focusing on standard analytical performance metrics like linearity, precision, and correlation. There is no mention of AI, ML, or any computational methods beyond basic data analysis for performance evaluation.
No
The device is a reagent/calibrator used for quantitative determination of bilirubin, which is a diagnostic tool, not a therapeutic one.
Yes
Explanation: The "Intended Use/Indications for Use" section explicitly states that the results obtained from these reagents "may be used for the diagnosis and treatment of liver, hematological, and metabolic disorders, including hepatitis and gall bladder block." This directly indicates a diagnostic purpose.
No
The device description clearly states it is a "two-part reagent" and a "liquid stable bilirubin calibrator," which are physical components, not software. The performance studies also focus on the chemical properties and performance of these reagents and calibrator.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states the reagents are for the "quantitative determination of conjugated (direct) bilirubin in serum and plasma" and "total bilirubin in serum and plasma." It also states that the results "may be used for the diagnosis and treatment of liver, hematological, and metabolic disorders." This clearly indicates the device is intended for use in vitro (outside the body) to examine specimens (serum and plasma) from the human body for the purpose of providing information for diagnosis and treatment.
- Device Description: The description details the chemical reactions used to measure bilirubin in the samples, which is a characteristic of in vitro diagnostic tests.
- Performance Studies: The performance studies describe the evaluation of the device's ability to accurately and reliably measure bilirubin in serum and plasma samples.
- Predicate Devices: The listed predicate devices are also IVD reagents and calibrators used for bilirubin testing.
All of these factors align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Vitalab Direct Bilirubin Reagent is intended for use with the Vitalab Selectra Analyzer for the quantitative determination of conjugated (direct) bilirubin in serum and plasma. Direct bilirubin results may be used for the diagnosis and treatment of liver, hematological, and metabolic disorders, including hepatitis and gall bladder block.
The Vitalab Total Bilirubin Reagent is intended for use with the Vitalab Selectra Analyzer for the quantitative determination of total bilirubin in serum and plasma. Total bilirubin results may be used for the diagnosis and treatment af liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block.
The Vitalab Bilirubin Calibrator is intended to calibrate the Vitalab Selectra Analyzer for the quantitative determination of total and direct bilirubin in serum and plasma.
Product codes (comma separated list FDA assigned to the subject device)
CIG, JIT
Device Description
The Vitalab Direct Bilirubin Reagent is a two-part reagent for use with the Vitalab Selectra Analyzer. This reagent determines conjugated bilirubin through a reaction with diazotized 2,4-dichloroanaline to produce a colored chromogen in acidic solution.
The Vitalab Total Bilirubin Reagent is a two-part reagent for use with the Vitalab Selectra Analyzer. This reagent determines total bilirubin through a reaction with diazotized 2,4-dichloroanaline in the presence of detergents to produce a colored chromogen in acidic solution.
The Vitalab Bilirubin Calibrator is a liquid stable bilirubin calibrator prepared from purified components in a human serum albumin matrix. Bilirubin set points are traceable to NIST reference materials.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The Vitalab Direct Bilirubin Reagent is linear to at least 10.0 mg/dL, as shown by the recovery of Usable Range: linearity related, human serum reference pools that span the linear range of the assay. Least squares regression statistics compare recoveries to dilution factors.
(Vitalab Recoveries) = 0.2 mg/dL + 0.834 x (Reference), r=0.9995, syx = 0.12 mg/dL, n = 32
Detection Limit: The detection limit is shown through the repetitive assay of normal saline. The observed mean and standard deviation of a 30 replicate within run precision study are both 0 mg/dL. The detection limit, calculated as the mean recovery plus two standard deviations is 0.0 mg/dL.
Precision is demonstrated by the replicate assay of control serum. Precision statistics, calculated Precision: analogous to the method described in NCCLS Guideline EP3-T, are shown below.
Sample: Serum 1; n: 66; mean: 0.3; Within Run 1SD: 0.03; Within Run %CV: 11.3%; Total 1SD: 0.03; Total %CV: 11.4%
Sample: Serum 2; n: 66; mean: 1.7; Within Run 1SD: 0.02; Within Run %CV: 1.3%; Total 1SD: 0.05; Total %CV: 2.8%
Sample: Serum 3; n: 66; mean: 4.0; Within Run 1SD: 0.02; Within Run %CV: 0.5%; Total 1SD: 0.10; Total %CV: 2.6%
Forty nine serum and 41 plasma specimens from adult patients were assayed for direct bilirubin using Correlation: the Vitalab Selectra E Analyzer and another commercially available method. Results were compared by Deming regression and the following statistics were obtained.
Selectra = 0.05 mp/dL + 0.832 x Competitive Reagent range = 0.1 - 11.6 mg/dL s. = 0.14 mg/dL n = 90
The 14 day onboard reagent stability and 7 day calibration stability claims are documented through the Stability: assay of serum convols over the claimed periods. In all cases, statistical estimates of total imprecision are less than 0.2 ms/dL.
The Vitalab Total Bilirubin Reagent is linear to at least 25.0 mg/dL, as shown by the recovery of Usable Range: linearity related, human serum reference pools that span the linear range of the assay. Least squares regression statistics compare recoveries to dilution factors.
(Vitalab Recoveries) = 0.2 mg/dL + 0.888 x (Reference), r = 0.9999, syx = 0.16 mg/dL, n = 36
Detection Limit: The detection limit is shown through the repetitive assay of normal saline. The observed mean and standard deviation of a 30 replicate within run precision study are both 0 mg/dL. The detection limit, calculated as the mean recovery plus two standard deviations is 0.0 mg/dL.
Precision is demonstrated by the replicate assay of control serum. Precision statistics, calculated Precision: analogous to the method described in NCCLS Guideline EP3-T, are shown below.
Sample: Serum 1; n: 54; mean: 0.4; Within Run 1SD: 0.02; Within Run %CV: 5.8%; Total 1SD: 0.03; Total %CV: 6.7%
Sample: Serum 2; n: 54; mean: 1.4; Within Run 1SD: 0.04; Within Run %CV: 3.1%; Total 1SD: 0.07; Total %CV: 4.8%
Sample: Serum 3; n: 54; mean: 5.8; Within Run 1SD: 0.07; Within Run %CV: 1.1%; Total 1SD: 0.15; Total %CV: 2.5%
Fifty nine serum and 44 heparinized plasma specimens from adult patients were assayed for total Correlation: bilirubin using the Vitalab Selectra E Analyzer and another commercially available method. Results were compared by Deming regression and the following statistics were obtained.
Selectra = - 0.4 mg/dL + 1.037 x Competitive Reagent range = 0.1 - 25.9 mg/dL s. . = 0.20 mg/dL n = 103
The 7 day onboard reagent stability and 7 day calibration stability claims are documented through the Stability: assay of serum controls over the claimed periods. In all cases, statistical estimates of total imprecision are less than 0.2 mg/dL.
The accuracy of the assigned set points is documented through method comparison studies. At least Accuracy: 40 serum and plasma specimens from adult patient were assayed for total and direct bilirubin over at least four analytical runs using commercially available methods and Vitalab reagents calibrated with the Vitalab Bilirubin Calibrator.
Deming regression statistics for both total and direct bilirubin are summarized below.
Direct Bilirubin Selectra = 0.05 mg/dL + 0.832 x Competitive Reagent range = 0.1 - 11.6 mg/dL n = 90 s . = 0.14 mg/dL Total Bilirubin Selectra = - 0.4 mg/dL + 1.037 x Competitive Reagent syx=0.20 mg/dL n = 103 range = 0.1 - 25.9 mg/dL
The open stability claim is confirmed by assaying the total and direct bilirubin levels in vials that have Open Stability: been open for increasing lengths of time. All observed changes in both the total and conjugated bilirubin levels over 3 days at 2℃ to 8℃ were less than 0.03 mg/dL.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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).
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§ 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
MAR 1 8 2004
Summary of 510(k) Safety and Effectiveness Information Vitalab Direct Bilirubin Reagent
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
Submitted by:
| | Clinical Data, Inc.
1075 West Lambert Road, Building D
Brea, California 92861 | | |
|-----------------|-------------------------------------------------------------------------------------|--|--|
| Contact Person: | Wynn Stocking | | |
| | Regulatory Affairs Manager | | |
| Date Submitted: | January 20, 2003 | | |
Device Names:
| Proprietary name: | Vitalab Direct Bilirubin Reagent |
|---|---|
| Common name: | Conjugated (direct) bilirubin reagent |
| Classification Name: | Diazo colorimetry, bilirubin |
| Proprietary name: | Vitalab Total Bilirubin Reagent |
| Proprietary name: | Vitalab Total Bilirubin Reagent |
|---|---|
| Common name: | Total bilirubin reagent |
| Classification Name: | Diazo colorimetry, bilirubin |
| Proprietary name: | Vitalab Bilirubin Calibrator |
Classification Name: Calibrator, multi-analyte mixture
Bilirubin calibrator
Device Descriptions:
Common name:
The Vitalab Direct Bilirubin Reagent is a two-part reagent for use with the Vitalab Selectra Analyzer. This reagent determines conjugated bilirubin through a reaction with diazotized 2,4-dichloroanaline to produce a colored chromogen in acidic solution.
The Vitalab Total Bilirubin Reagent is a two-part reagent for use with the Vitalab Selectra Analyzer. This reagent determines total bilirubin through a reaction with diazotized 2,4-dichloroanaline in the presence of detergents to produce a colored chromogen in acidic solution.
The Vitalab Bilirubin Calibrator is a liquid stable bilirubin calibrator prepared from purified components in a human serum albumin matrix. Bilirubin set points are traceable to NIST reference materials,
1
Intended Uses:
The Vitalab Direct Bilirubin Reagent is intended for use with the Vitalab Selectra Analyzer for the quantitative determination of conjugated (direct) bilirubin in serum and plasma. Direct bilirubin results may be used for the diagnosis and treatment of liver, hematological, and metabolic disorders, including hepatitis and gall bladder block.
The Vitalab Total Bilirubin Reagent is intended for use with the Vitalab Selectra Analyzer for the quantitative determination of total bilirubin in serum and plasma. Total bilirubin results may be used for the diagnosis and treatment af liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block.
The Vitalab Bilirubin Calibrator is intended to calibrate the Vitalab Selectra Analyzer for the quantitative determination of total and direct bilirubin in serum and plasma.
Predicate Devices:
The Vitalab Direct Bilirubin Reagent Kit is substantially equivalent to the Roche Direct Bilirubin Reagent, product no. 0737499, which is currently marketed by Roche Diagnostics Corp. of Indianapolis, IN.
The Vitalab Total Bilirubin Reagent Kit is substantially equivalent to the Beckman Total Bilirubin Reagent, product no 442745, which is currently marketed by Beckman Coulter, Inc. of Brea, CA.
The Vitalab Bilirubin Calibrator is substantially equivalent to the Beckman Bilirubin Calibrator, product no. 465915, which is currently marketed by Beckman Coulter, Inc. of Brea, CA.
Summary of Performance Data for the Vitalab Direct Bilirubin Reagent:
-
The Vitalab Direct Bilirubin Reagent is linear to at least 10.0 mg/dL, as shown by the recovery of Usable Range: linearity related, human serum reference pools that span the linear range of the assay. Least squares regression statistics compare recoveries to dilution factors.
(Vitalab Recoveries) = 0.2 mg/dL + 0.834 x (Reference), r=0.9995, syx = 0.12 mg/dL, n = 32 -
Detection Limit: The detection limit is shown through the repetitive assay of normal saline. The observed mean and standard deviation of a 30 replicate within run precision study are both 0 mg/dL. The detection limit, calculated as the mean recovery plus two standard deviations is 0.0 mg/dL.
-
Precision is demonstrated by the replicate assay of control serum. Precision statistics, calculated Precision: analogous to the method described in NCCLS Guideline EP3-T, are shown below.
| Sample | n | mean | Within Run | Total | ||
|---|---|---|---|---|---|---|
| 1SD | %CV | 1SD | %CV | |||
| Serum 1 | 66 | 0.3 | 0.03 | 11.3% | 0.03 | 11.4% |
| Serum 2 | 66 | 1.7 | 0.02 | 1.3% | 0.05 | 2.8% |
| Serum 3 | 66 | 4.0 | 0.02 | 0.5% | 0.10 | 2.6% |
Forty nine serum and 41 plasma specimens from adult patients were assayed for direct bilirubin using Correlation: the Vitalab Selectra E Analyzer and another commercially available method. Results were compared by Deming regression and the following statistics were obtained.
Selectra = 0.05 mp/dL + 0.832 x Competitive Reagent range = 0.1 - 11.6 mg/dL s. = 0.14 mg/dL n = 90
- The 14 day onboard reagent stability and 7 day calibration stability claims are documented through the Stability: assay of serum convols over the claimed periods. In all cases, statistical estimates of total imprecision are less than 0.2 ms/dL.
2
Summary of Performance Data for the Vitalab Total Bilirubin Reagent:
-
The Vitalab Total Bilirubin Reagent is linear to at least 25.0 mg/dL, as shown by the recovery of Usable Range: linearity related, human serum reference pools that span the linear range of the assay. Least squares regression statistics compare recoveries to dilution factors.
(Vitalab Recoveries) = 0.2 mg/dL + 0.888 x (Reference), r = 0.9999, syx = 0.16 mg/dL, n = 36 -
Detection Limit: The detection limit is shown through the repetitive assay of normal saline. The observed mean and standard deviation of a 30 replicate within run precision study are both 0 mg/dL. The detection limit, calculated as the mean recovery plus two standard deviations is 0.0 mg/dL.
-
Precision is demonstrated by the replicate assay of control serum. Precision statistics, calculated Precision: analogous to the method described in NCCLS Guideline EP3-T, are shown below.
| Sample | n | mean | Within Run | Total | ||
|---|---|---|---|---|---|---|
| 1SD | %CV | 1SD | %CV | |||
| Serum 1 | 54 | 0.4 | 0.02 | 5.8% | 0.03 | 6.7% |
| Serum 2 | 54 | 1.4 | 0.04 | 3.1% | 0.07 | 4.8% |
| Serum 3 | 54 | 5.8 | 0.07 | 1.1% | 0.15 | 2.5% |
Fifty nine serum and 44 heparinized plasma specimens from adult patients were assayed for total Correlation: bilirubin using the Vitalab Selectra E Analyzer and another commercially available method. Results were compared by Deming regression and the following statistics were obtained.
Selectra = - 0.4 mg/dL + 1.037 x Competitive Reagent range = 0.1 - 25.9 mg/dL s. . = 0.20 mg/dL n = 103
- The 7 day onboard reagent stability and 7 day calibration stability claims are documented through the Stability: assay of serum controls over the claimed periods. In all cases, statistical estimates of total imprecision are less than 0.2 mg/dL.
Summary of Performance Data for the Vitalab Bilirubin Calibrator:
The accuracy of the assigned set points is documented through method comparison studies. At least Accuracy: 40 serum and plasma specimens from adult patient were assayed for total and direct bilirubin over at least four analytical runs using commercially available methods and Vitalab reagents calibrated with the Vitalab Bilirubin Calibrator.
Deming regression statistics for both total and direct bilirubin are summarized below.
Direct Bilirubin Selectra = 0.05 mg/dL + 0.832 x Competitive Reagent range = 0.1 - 11.6 mg/dL n = 90 s . = 0.14 mg/dL Total Bilirubin Selectra = - 0.4 mg/dL + 1.037 x Competitive Reagent syx=0.20 mg/dL n = 103 range = 0.1 - 25.9 mg/dL
- The open stability claim is confirmed by assaying the total and direct bilirubin levels in vials that have Open Stability: been open for increasing lengths of time. All observed changes in both the total and conjugated bilirubin levels over 3 days at 2℃ to 8℃ were less than 0.03 mg/dL.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAR 1 8 2004
Clinical Data, Inc. c/o Mr. Ned E. Devine Entela, Inc 3033 Madison Avenue, SE Grand Rapids, MI 49548
K040631 Re:
Trade/Device Name: Vitalab Direct Bilirubin Reagent Vitalab Total Bilirubin Reagent Vitalab Bilirubin Calibator Regulation Number: 21 CFR 862.1110 Regulation Name: Bilirubin (total or direct) test system Regulatory Class: Class II
Product Code: CIG; JIT Dated: March 10, 2004
Received: March 10, 2004
Dear Mr. Devine:
We have reviewed your Section 510(k) premarket notification of intent to market the device refercnced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
4
Page 2
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Jean M. Cooper, MS, DVM.
MS, DVM.
Yean M. Cooper, MS, D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
5
510(k) Number (if known):
Device Name:
Vitalab Direct Bilirubin Reagent
Indications for Use:
The Vitalab Direct Bilirdbin Reagent is intended for use with the Vitalia assults may be wed for the diamons The Vitalab Direct Bilirubin Reagent is Intil in 1 Min 1 Miro Colicioline in results may be used for the diagnosis
determination of conjugated (direct) bilinuin in serum and determination of conjugated (direct) officially in scrum and plastill. Directors, including hepatitis and gall bladder block.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use $\underline{\checkmark}$
(Per 21 CFR 801.109)
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Form
Optional Format P-96)
Carol C. Benson
Division Sign-Off
Office of In Vitro Diagnostic Device
Evaluation and Safety
January 20, 2004
Page 87 of 95
Clinical Data, Brea, California
6
510(k) Number (if known):
Device Name:
Vitalab Total Bilirubin Reagent
Indications for Use:
The Vitalab Total Bilirubin Reagent is intended for use with the Vitalab Selectra Analyzer as a system for the quantitive The Villab Total Billirubin Reagen is millibe vilance Use and be sub coll on the plager es and geatment of uccentination of total officablic disorders, including hepatitis and gall bladder block.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
C(Optional Format 1-2-96)
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Sat
510(k) K04 0631
January 20, 2004 Page 88 of 95
7
510(k) Number (if known):
Device Name:
Vitalab Bilirubin Calibrator
Indications for Use:
The Vitalab Bilirubin Calibrator is intended for use with the Vitalab Selectra Analyzer to establish points of reference that The Vitalab Billruom Callorator is intended for ass whit no "(time specimens.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
Optional Format 1-2-96)
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K040631
510(k) Notification, Vitalab Billirubin Reagents and Calibrator Clinical Data, Brea, California
20, 2004
January 20, 2004 Page 89 of 95