K Number
K024116
Device Name
WIENER LAB. BILIRUBINA DIRECT AA
Date Cleared
2003-02-12

(61 days)

Product Code
Regulation Number
862.1110
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The "Wiener lab. Bilirrubina directa AA" test system is a quantitative in vitro diagnostic device intended to be used in the determination of direct bilirubin in human sera and heparinized plasmas on both manual and automated systems. Measurements of the levels of bilirubin, and 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 Description
Direct bilirubin is measured using a stable dichlorophenyldiazonium salt (DPD) to form a red azocompound in an acid solution, with maximal O.D. at 546 nm. The amount of direct bilirubin is determined by measuring the absorbance of this pigment.
More Information

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Not Found

No
The description details a chemical reaction and spectrophotometric measurement, with no mention of AI or ML.

No
This device is an in vitro diagnostic (IVD) device used to measure direct bilirubin levels, which aids in diagnosis and treatment monitoring, but it does not directly treat or prevent a disease.

Yes
The "Intended Use / Indications for Use" section explicitly states that the device is a "quantitative in vitro diagnostic device" and describes its use in the "diagnosis and treatment of liver, hemolytic, hematological, and metabolic disorders".

No

The device description clearly describes a chemical assay ("stable dichlorophenyldiazonium salt (DPD) to form a red azocompound") and mentions measuring absorbance, indicating a physical, in vitro diagnostic test system, not a software-only device.

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use/Indications for Use: The very first sentence explicitly states it is a "quantitative in vitro diagnostic device". It also describes its intended use in determining direct bilirubin in human samples for the diagnosis and treatment of various medical conditions.
  • Device Description: The description details how the test works by measuring a substance in a biological sample (bilirubin in serum/plasma) using a chemical reaction and absorbance measurement. This is characteristic of an in vitro diagnostic test.

N/A

Intended Use / Indications for Use

The WIENER LAB. BILIRRUBINA DIRECTA AA test system is a quantitative in vitro diagnostic device intended to be used in the determination of direct billirubin in human sera and heparinized plasmas on both manual and automated systems. Measurements of the levels of bilirubin, and 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.

Product codes

CIG

Device Description

Direct bilirubin is measured using a stable dichlorophenyldiazonium salt (DPD) to form a red azocompound in an acid solution, with maximal O.D. at 546 nm. The amount of direct bilirubin is determined by measuring the absorbance of this pigment.

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 document provides comparative performance metrics between the subject device (WIENER LAB. Test System) and the predicate device (DMA Test System) including:

  • Linearity: WIENER LAB. Test System: 14 mg/dl; DMA Test System: 12 mg/dl
  • Expected values: WIENER LAB. Test System: 0.0 — 0.2 mg/dl
  • Within-run precision:
    • Normal Level Serum: WIENER LAB. CV = 4.03%; DMA CV =

§ 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 is a circular seal with the text "Wiener lab." at the top and "SISTEMA DE CALIDAD CERTIFICADO" at the bottom. In the center of the seal, there is a logo with the letters "ISO 9001" above the letters "TUV".

Image /page/0/Picture/2 description: The image shows the logo for Wiener lab. The logo consists of a stylized "W" inside of a circle on the left, followed by the text "Wiener lab." in a bold, sans-serif font. Below the company name is the text "Especialidades para Laboratorios Clinicos" in a smaller font.

IENER LABORATORIO Phone +54 (341) 432

2 2003

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"

"The assigned 510(k) number is:_YDAH || ج

IntroductionAccording to the requirements of 21 CFR 862.1110, the following 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: September 15, 2002 |
|--------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 6-2 Device Name | Proprietary name: Wiener lab. BILIRRUBINA DIRECTA AA

Common name: Bilirubin (total or direct) test system

Classification name: Diazo colorimetry Bilirubin |

Device Class II

1

  • 6-3 Predicate We claim substantial equivalence to the currently marketed DMA Direct Bilirubin Plus test system (Cat. Nº1225). Device
  • 6-4 Device Direct bilirubin is measured using a stable dichloro-Description phenyldiazonium salt (DPD) to form a red azocompound in an acid solution, with maximal O.D. at 546 nm.

The amount of direct bilirubin is determined by measuring the absorbance of this pigment.

  • 6-5 Intended Use The WIENER LAB. BILIRRUBINA DIRECTA AA test system is a quantitative in vitro diagnostic device intended to be used in the determination of direct billirubin in human sera and heparinized plasmas on both manual and automated systems. Measurements of the levels of bilirubin, and 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 LAB. BILIRRUBINA DIRECTA 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 Direct Bilirubin Plus test system.

The following table illustrates the similarities and differences between the WIENER LAB. Bilirrubina Directa AA test system and the currently marketed DMA Direct Bilirubin Plus test svstem.

| | DMA
Test System | WIENER LAB.
Test System |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Quantitative
determination of direct
bilirubin in human serum. | Quantitative
determination of direct
bilirubin in human serum
and heparinized plasma. |
| | | Continued on next page |
| | DMA
Test System | WIENER LAB.
Test System |
| Test Principle | Conjugated billirubin
reacts with diazotized
sulfanilic acid to produce
an acid azobilirubin, the
absorbance of which is
proportional to the
concentration of direct
bilirubin in the sample
can be measured at 550
nm. | Direct bilirubin is
measured using a stable
dichlorophenyldiazonium
salt (DPD) to form a red
azocompound in an acid
solution, with maximal
O.D. at 546 nm. The
amount of direct bilirubin
is determined by
measuring the
absorbance of this
pigment. |
| Reagents | Bilirubin Reagent:
hydrochloric acid and
sulfanilic acid.
Sodium Nitrite Reagent:
sodium nitrite. | R1: sulfamic acid.
R2: dichlorophenyl-
diazonium salt.
Reagent for sample
blank: sulfamic acid. |
| Sample | Human serum. | Human serum and
heparinized plasma. |
| Wavelength of
Reading | 550 nm | Spectrophotometer:
546 nm
Photocolorimeter with
green filter:
520 - 550 nm |
| Linearity | 12 mg/dl | 14 mg/dl |
| Expected
values | | 0.0 — 0.2 mg/dl |
| | | Continued on next page |
| | DMA
Test System | WIENER LAB.
Test System |
| Within-run
precision | Normal Level Serum:
CV =