(270 days)
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No
The summary describes a chemical reagent kit and a chemistry system that measures conjugated bilirubin based on a chemical reaction and absorbance. There is no mention of AI or ML in the device description, intended use, or performance studies.
No.
This device is an in vitro diagnostic reagent kit used for the quantitative determination of conjugated bilirubin, which aids in diagnosis and treatment, but it does not directly treat a disease or condition.
Yes
The device is described as "a system for the quantitative determination of conjugated bilirubin in serum and plasma," and the results are "used for the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders." This clearly indicates its role in diagnosis.
No
The device is a reagent kit and calibrator, which are physical components used in a chemistry system. The description focuses on the chemical reaction and performance characteristics of these physical reagents, not on software functionality.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "quantitative determination of conjugated bilirubin in serum and plasma." This involves testing samples taken from the human body (in vitro) to provide information for diagnosis and treatment.
- Purpose: The results are used for the "diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders." This directly aligns with the purpose of IVD devices, which are used to examine specimens from the human body to provide information for clinical purposes.
- Device Description: It describes a "Reagent Kit" which is a common component of IVD systems used for chemical analysis of biological samples.
- Performance Studies: The document details performance studies like linearity, precision, and method comparison, which are standard evaluations for IVD devices to demonstrate their analytical performance.
- Predicate Device: The mention of a predicate device (Trace Direct Bilirubin Reagent) is typical for submissions of new IVD devices to regulatory bodies, demonstrating substantial equivalence to a legally marketed device.
All these factors strongly indicate that the ATAC Direct Bilirubin Reagent Kit is an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ATAC Direct Bilirubin Reagent Kit is intended for the quantitative determination of conjugated billrubin in serum and plasma. Conjugated bilirubin results are used for the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block.
Product codes (comma separated list FDA assigned to the subject device)
CIG; JIS
Device Description
The ATAC Direct Bilirubin Reagent determines conjugated bilirubin through its reaction with diazotized sulfanilic acid to form a red-purple complex. The resulting increase in absorbance at 546 nm is proportional to the direct bilirubin concentration in the sample.
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
This reagent is intended to be used by trained personnel in a professional setting and is not intended for home use.
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 recovery of conjugated bilirubin using the ATAC Direct Bilirubin Reagent is linear from 0.1 to 20 mg/dL, as shown by the recovery of linearity standards that span the usable range. Regression statistics compare standard recoveries to standard values. These statistics are shown below.
(ATAC Recoveries) = 0.11 mg/dL + 6.66 x (Standard Factor), r = 0.999, sy.x = 0.29 mg/dL, n = 18
Precision is demonstrated by the replicate assay of commercially available control serum.
Precision of Conjugated Bilirubin Recoveries in mg/dl:
| Sample | n | mean | Within Run 1SD | %CV | Total 1SD | %CV |
|---|---|---|---|---|---|---|
| Serum 1 | 60 | 0.9 | 0.10 | 10.3% | 0.09 | 9.2% |
| Serum 2 | 60 | 3.8 | 0.11 | 3.0% | 0.13 | 3.4% |
| Serum 3 | 60 | 6.7 | 0.12 | 1.9% | 0.18 | 2.7% |
Mixed serum and plasma specimens, collected from adult patients, were assayed in duplicate for conjugated bilirubin using the ATAC 8000 Random Access Chemistry System and another commercially available method. Each pair of duplicate assays were examined and five specimens were excluded for poor reproducibility. The first assay values for the remaining duplicates were compared by Deming regression. Two additional results were excluded because their residuals exceeded 6 standard errors of regression statistics for the accepted results are shown below.
ATAC 8000 = - 0.10 mg/dL + 1.143 x Competitive Reagent Sy.x = 0.32 mg/dL n = 96 range = 0.0 - 17.5 mg/dL
The detection limit of 0.1 mg/dL is documented through the repetitive assay of a diluted serum pool. The observed total standard deviation of 125 results over 25 runs was 0.09 mg/dL. Consequently, the detection limit is reported as the round-off error of the assay.
The 5 day onboard reagent stability and calibration stability claims are documented through the assay of serum controls over the claimed periods. In all cases, estimates of the total imprecision of conjugated bilirubin recoveries over the test periods are less than 0.15 mg/dL or 3%.
The 14 day reconstituted stability claim is documented through the assay of serum pools and linearity standards. Observed shifts in recoveries over the 14 day period are less than 0.1 mg/dL or 6%.
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
SEP 2 9 2003
Brea, CA 92821 T (714) 672-3553 F (714) 672-3554
SUMMARY OF 510(K) SAFETY AND EFFECTIVENESS INFORMATION
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.
The ATAC Direct Bilirubin Reagent Kit is intended for the quantitative determination of conjugated billrubin in serum and plasma. Conjugated bilirubin results are used for the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block. The ATAC Direct Bilirubin Reagent determines conjugated bilirubin through its reaction with diazotized sulfanilic acid to form a red-purple complex. The resulting increase in absorbance at 546 nm is proportional to the direct bilirubin concentration in the sample.
The ATAC Direct Bilirubin Reagent Kit, which contains both reagent and calibrator, is substantially equivalent to the Trace Direct Bilirubin Reagent, product UG38 (Trace Scientific, Ltd. of Melbourne, Australia) calibrated with the Sigma Bilirubin Calibrator, Total and Direct, product no. B8652 (Sigma Diagnostics, Inc. St. Louis, MO). The effectiveness of ATAC Direct Bilirubin Reagent Kit on the ATAC 8000 Random Access Chemistry System is shown in the following studies.
The recovery of conjugated bilirubin using the ATAC Direct Bilirubin Reagent is linear from 0.1 to 20 mg/dL, as shown by the recovery of linearity standards that span the usable range. Regression statistics compare standard recoveries to standard values. These statistics are shown below.
(ATAC Recoveries) = 0.11 mg/dL + 6.66 x (Standard Factor), r = 0.999, sy.x = 0.29 mg/dL, n = 18
Precision is demonstrated by the replicate assay of commercially available control serum. Precision statistics, calculated 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 | 60 | 0.9 | 0.10 | 10.3% | 0.09 | 9.2% |
| Serum 2 | 60 | 3.8 | 0.11 | 3.0% | 0.13 | 3.4% |
| Serum 3 | 60 | 6.7 | 0.12 | 1.9% | 0.18 | 2.7% |
Precision of Conjugated Bilirubin Recoveries in mg/dl
Mixed serum and plasma specimens, collected from adult patients, were assayed in duplicate for conjugated bilirubin using the ATAC 8000 Random Access Chemistry System and another commercially available method. Each pair of duplicate assays were examined and five specimens were excluded for poor reproducibility. The first assay values for the remaining duplicates were compared by Deming regression. Two additional results were excluded because their residuals exceeded 6 standard errors of regression statistics for the accepted results are shown below.
ATAC 8000 = - 0.10 mg/dL + 1.143 x Competitive Reagent Sy.x = 0.32 mg/dL n = 96 range = 0.0 - 17.5 mg/dL
The detection limit of 0.1 mg/dL is documented through the repetitive assay of a diluted serum pool. The observed total standard deviation of 125 results over 25 runs was 0.09 mg/dL. Consequently, the detection limit is reported as the round-off error of the assay.
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The 5 day onboard reagent stability and calibration stability claims are documented through the assay of serum controls over the claimed periods. In all cases, estimates of the total imprecision of conjugated bilirubin recoveries over the test periods are less than 0.15 mg/dL or 3%.
The 14 day reconstituted stability claim is documented through the assay of serum pools and linearity standards. Observed shifts in recoveries over the 14 day period are less than 0.1 mg/dL or 6%.
Wyman Stocker
Wynn Stocking Manager of Regulatory Affairs June 30, 2003
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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized caduceus, a symbol often associated with healthcare, with three lines forming the snake and a wavy line at the bottom. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" is arranged in a circular fashion around the caduceus.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
SEP 2 9 2003
Mr. Wynn Stocking Manager, Regulatory Affairs Elan Diagnostics 1075 W. Lambert Road - Suite D Brea, CA 92821
K030003 Re: Trade/Device Name: ATAC Direct Bilirubin Reagent and Calibrator Regulation Number: 21 CFR 862.1110 Regulation Name: Bilirubin (total or direct) test system Regulatory Class: Class II Product Code: CIG; JIS Dated: June 30, 2003 Received: July 1, 2003
Dear Mr. Stocking:
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.
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).
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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,
Steven Butman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known):
Device Name:
ATAC Direct Bilirubin Reagent and Calibrator
Indications for Use:
The ATAC Direct Bilirubin Reagent Kit, which contains both reagent and calibrator, is intended for use with the ATAC 8000 Random Access Chemistry System as a system for the quantitative determination of conjugated bilirubin in serum and plasma. Conjugated bilirubin results are used for the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block.
This reagent is intended to be used by trained personnel in a professional setting and is not intended for home use.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Sean Cooper
(Division Sign-Off) Division of Clinical Laboratory Devices > 510(k) Number -
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)