← Product Code [CIG](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIG) · K022962 # WIENER LAB. BILIRRUBINA TOTAL AA (K022962) _Wiener Laboratories Saic · CIG · Nov 1, 2002 · Clinical Chemistry · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIG/K022962 ## Device Facts - **Applicant:** Wiener Laboratories Saic - **Product Code:** [CIG](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIG.md) - **Decision Date:** Nov 1, 2002 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 862.1110 - **Device Class:** Class 2 - **Review Panel:** Clinical Chemistry - **Attributes:** Pediatric ## Indications for Use The "Wiener lab. Bilirrubina Total AA" test system is a quantitative in vitro diagnostic device intended to be used in the quantitative determination of total bilirubin in human sera and heparinized plasmas on both manual and automated systems. Measurements of the levels of bilirubin, 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. ## Device Story The Wiener lab. Bilirrubina Total AA is an in vitro diagnostic test system for measuring total bilirubin in human serum and heparinized plasma. The device uses a diazo colorimetric method where a stable dichlorophenyl diazonium salt (DPD) reacts with bilirubin to form an azobilirubin compound. Surfactants act as reaction accelerators. The amount of bilirubin is determined by measuring the absorbance of the resulting pigment at 546 nm. The test is performed in clinical laboratories using manual or automated systems. Healthcare providers use the quantitative results to diagnose and monitor liver, hemolytic, hematological, and metabolic disorders. The device provides clinical utility by identifying abnormal bilirubin levels associated with conditions like hepatitis and gall bladder obstruction. ## Clinical Evidence Bench testing only. Performance data provided includes within-run and run-to-run precision studies. Within-run precision (CV) reported as 1.50% for normal level serum and 0.98% for high level serum. Run-to-run precision (CV) reported as 2.68% for normal level serum and 1.08% for high level serum. No clinical prospective or retrospective studies were required for this determination. ## Technological Characteristics Diazo colorimetric assay. Reagents: R1 (hydrochloric acid, surfactant) and R2 (dichlorophenyl diazonium salt). Principle: DPD reaction with bilirubin forming azobilirubin measured at 546 nm. Form factor: Reconstitutable liquid reagents. Compatibility: Manual and automated clinical laboratory systems. ## Regulatory 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. ## Predicate Devices - DMA Total Bilirubin Plus test system (Cat. Nº 1245) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ NOV 1 2002 K622962 BILIRRUBINA TOTAL AA Wiener lab. Image /page/0/Picture/3 description: The image shows the logo for Wiener lab. The logo consists of a stylized "W" symbol on the left, followed by the text "Wiener lab." in a bold, sans-serif font. Below the company name, there is the text "Especialidades para Laboratorios Clinicos" in a smaller font, which translates to "Specialties for Clinical Laboratories". **WIENER LABORATORIOS S.A.I.C.** - Riobamba 2944 - 2000 Rosario - Argentina Phone +54 (341) 432-9191/6 - Fax +54 (341) 432-5454/5555 Internet: http://www.wiener-lab.com.ar ## Section 6 - Summary 510(k) Summary "This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21CFR 807.92" יי "The assigned 510(k) number is: _ According to the requirements of 21 CFR 862.1110, the following Introduction information provides sufficient details to understand the basis of a determination of substantial equivalence. | 6-1 Submitter Name, Address, Contact | Wiener Laboratorios S.A.I.C.
Riobamba 2944
2000 - Rosario - Argentina
Tel: 54 341 4329191
Fax: 54 341 4851986
Contact person: Viviana Cétola
Date Prepared: July 07, 2002 | |--------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 6-2 Device Name | Proprietary name: Wiener lab. BILIRRUBINA TOTAL AA
Common name: Bilirubin (total) test system | | | Classification name: Diazo colorimetry, Bilirubin Device Class II,
CIG, as per 21 CFR section 862.1110.
Device Class II | {1}------------------------------------------------ We claim substantial equivalence to the currently marketed 6-3 Predicate DMA Total Bilirubin Plus test system (Cat. Nº 1245). Device Total bilirubin (both conjugated and free) is measured using a 6-4 Device stable dichlorophenyl diazonium salt (DPD) to form an Description azobilirubin compound with maximal O.D. at 546 nm. Surfactants are used as reaction accelerators. > The amount of bilirubin is determined by measuring the absorbance of this pigment. - The WIENER LAB. BILIRRUBINA TOTAL AA test system is a 6-5 Intended Use quantitative in vitro diagnostic device intended to be used in the quantitative determination of total bilirubin in human sera and heparinized plasmas on both manual and automated systems. Measurements of the levels of bilirubin, 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. 6-6 Equivalencies The WIENER BILIRUBIN TOTAL AA test system is and Differences substantially equivalent to other products in commercial distribution intended for similar use. Most notably it is substantially equivalent to the currently marketed DMA Total Bilirubin Plus test system. > The following table illustrates the similarities and differences between the WIENER BILIRUBIN test system and the currently marketed DMA Total Bilirubin Plus test system. | | DMA
Test System | WIENER LAB.
Test System | |-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use | Quantitative
determination of total
bilirubin in human serum
and EDTA or heparinized
plasma. | Quantitative
determination of total
bilirubin in human serum
and heparinized plasma. | | | Continued on next page | | | | DMA
Test System | WIENER LAB.
Test System | | Test Principle | Total bilirubin (both
conjugated and free) is
measured using a
stabilized diazonium salt
of 3,5-dichloroaniline
which reacts with
bilirubin to form
azobilirubin with
maximum absorbance at
540 nm. Surfactants are
used as reaction
accelerators. | Total bilirubin (both
conjugated and free) is
measured using a stable
dichlorophenyl diazonium
salt (DPD) to form an
azobilirubin compound
with maximal O.D. at 546
nm. Surfactants are used
as reaction accelerators. | | Reagents | Reagent: 3,5-
dichlorophenyldiazonium
tetrafluoroborate and
surfactants. | R1: hydrochloric acid
and surfactant.
R2: dichlorophenyl
diazonium salt.
Reagent for sample
blank: hydrochloric acid
and surfactant. | | Preparation of
Working Reagent | Ready to use | Reconstitute each
Reagent 2 vial with
stated volume of
Reagent 1. | | Stability of Final
Color | 60 minutes at room
temperature (15-30ºC) | 30 minutes at room
temperature | | Wavelength of
Reading | 540 nm | 546 nm | | Calibration | Single point | | | Linearity | 20 mg/dl | | | Expected values | 0.0 - 1.5 mg/dl | - Adults: up to 1.0 mg/dl
- Newborns: ranging from
2.0 to 16 mg/dl
depending on birth
condition (full term or
premature) and days of
life. | | Continued on next page | | | | | DMA
Test System | WIENER LAB.
Test System | | Within-run
precision | Low Serum Control:
CV = 5.00%
Moderate Serum Control:
CV = 2.20%
High Serum Control:
CV= 1.56% | Normal Level Serum:
CV = 1.50%
High Level Serum:
CV = 0.98% | | Run-to-run
precision | Low Serum Control:
CV = 6.40%
Moderate Serum Control:
CV = 0.83%
High Serum Control:
CV= 2.10% | Normal Level Serum:
CV = 2.68%
High Level Serum:
CV = 1.08% | {2}------------------------------------------------ {3}------------------------------------------------ ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ 6-7 Conclusion Above mentioned data show substantial equivalency to the predicate device. {4}------------------------------------------------ ## DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three abstract human profiles facing to the right, with flowing lines beneath them. Food and Drug Administration 098 Gaither Road Rockville MD 20850 ## 1 2002 Dr. Viviana Cetola OC/OA Manager Wiener Laboratorios S.A.I.C. Riobamba 2944 2000 Rosario, Santa Fe Argentina k022962 Re: > Trade/Device Name: Wiener Lab Bilirrubina Total AA Regulation Number: 21 CFR 862.1110 Regulation Name: Bilirubin (total or direct) test system Regulatory Class: Class II Product Code: CIG Dated: August 30, 2002 Received: September 6, 2002 Dear Dr. Cetola: 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 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); 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. {5}------------------------------------------------ ## Page 2 - This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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/cdrb/dsma/dsmamain.html". Sincerely yours, Steven Gutman Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory-Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {6}------------------------------------------------ | 510(k) Number (if known): | K032962 | |---------------------------|----------------------| | Device Name: | Wiener lab. | | | Bilirrubina Total AA | Page ofIndications For Use: The "Wiener lab. Bilirrubina Total AA" test system is a quantitative in vitro diagnostic device intended to be used in the quantitative determination of total bilirubin in human sera and heparinized plasmas on both manual and automated systems. Measurements of the levels of bilirubin, 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. (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) | |
Signature

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| |--|------------------------------------------------------------------------------------| | | Division of Clinical Laboratory Devices | | | 510(K) Number: K022962 | | Prescription Use | OR | Over-The-Counter Use | |----------------------|----|--------------------------| | (Per 21 CFR 801.109) | | (Optional Format 1-2-96) | --- **Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIG/K022962](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIG/K022962) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com