(61 days)
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.
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.
The provided text describes a 510(k) summary for the "WIENER LAB. BILIRRUBINA DIRECTA AA" test system, which is a quantitative in vitro diagnostic device for determining direct bilirubin in human sera and heparinized plasmas. The summary claims substantial equivalence to a predicate device, the DMA Direct Bilirubin Plus test system.
The document does not describe an acceptance criteria study in the way one would typically find for a medical device that uses algorithms or AI. This is a traditional in vitro diagnostic device (IVD) based on chemical reactions and spectrophotometric measurements, not an AI/ML powered device. Therefore, many of the requested categories in the prompt are not applicable.
However, I can extract the performance characteristics that serve as the "acceptance criteria" for chemical assays, by comparing them to a predicate device for demonstrating substantial equivalence. The "study" proving the device meets these criteria is an internal validation performed by Wiener Laboratorios S.A.I.C. for submission to the FDA.
Here is the information based on the provided text, with explanations for non-applicable categories:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by claiming substantial equivalence to the predicate device (DMA Direct Bilirubin Plus test system). The "reported device performance" are the values for the Wiener Lab. system.
| Performance Metric | Predicate Device (DMA Test System) (Implied Acceptance Standard) | Wiener Lab. Test System (Reported Performance) |
|---|---|---|
| Intended Use | Determination of direct bilirubin in human serum. | Determination of direct bilirubin in human serum and heparinized plasma. |
| Test Principle | Conjugated bilirubin reacts with diazotized sulfanilic acid. | Direct bilirubin measured using stable dichlorophenyldiazonium salt (DPD). |
| Wavelength of Reading | 550 nm | Spectrophotometer: 546 nm; Photocolorimeter: 520-550 nm |
| Linearity | 12 mg/dl | 14 mg/dl |
| Expected Values | (Not specified) | 0.0 – 0.2 mg/dl |
| Within-run precision (Normal Level Serum) | CV = <1% (DMA) / 4.03% (Wiener Lab.) | CV = 4.03% |
| Within-run precision (High Level Serum) | CV = 2.8% (DMA) / 1.33% (Wiener Lab.) | CV = 1.33% |
| Total-run precision (Normal Serum Control) | CV = 8.8% (DMA) / 5.09% (Wiener Lab.) | CV = 5.09% |
| Total-run precision (Abnormal Serum Control) | CV = 4.4% (DMA) / 2.00% (Wiener Lab.) | CV = 2.00% |
Note on Differences: While the predicate device had a stated "Within-run precision (Normal Level Serum)" of CV=<1%, the Wiener Lab device reported 4.03%. Similarly, the predicate's "Total-run precision (Normal Serum Control)" was 8.8% while Wiener Lab reported 5.09%. For "High Level Serum" and "Abnormal Serum Control", the Wiener Lab device shows better precision. The FDA found these differences acceptable for substantial equivalence.
2. Sample size used for the test set and the data provenance
The document does not specify the sample sizes used for the precision studies (within-run and total-run). It only provides the coefficient of variation (CV) results. The data provenance is internal validation conducted by Wiener Laboratorios S.A.I.C., an Argentinian company. The studies are implicitly prospective as they were performed to validate the new device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is an in vitro diagnostic (IVD) chemical assay, not an imaging or diagnostic AI device requiring expert interpretation for ground truth. The "ground truth" for this type of device is the actual concentration of bilirubin in a sample, typically determined by reference methods or validated controls, not by expert consensus.
4. Adjudication method for the test set
Not applicable. See point 3.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is an IVD chemical assay, not a device involving human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Yes, in a sense. The performance metrics (linearity, precision, etc.) are inherent to the chemical reagents and instrument's ability, independent of human interpretation of the results for the measurement itself. The "standalone" performance here refers to the analytical performance of the assay.
7. The type of ground truth used
For chemical assays like this, the ground truth is established by:
- Known concentrations: Using reference materials or calibrators with accurately determined bilirubin concentrations.
- Comparison to reference methods: Comparing results to a gold standard laboratory method if available.
- Quality control materials: Using commercial quality control sera with established target values.
The document does not explicitly state the specific methods used for ground truth determination, but these are standard practices for IVDs.
8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a training set. The performance is based on the chemical formulation and instrumentation.
9. How the ground truth for the training set was established
Not applicable. See point 8.
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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
| Introduction | According to the requirements of 21 CFR 862.1110, the following information provides sufficient details to understand the basis of a determination of substantial equivalence. |
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| 6-1 SubmitterName, Address,Contact | Wiener Laboratorios S.A.I.C.Riobamba 29442000 - Rosario - ArgentinaTel: 54 341 4329191Fax: 54 341 4851986Contact person: Viviana CétolaDate Prepared: September 15, 2002 |
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| 6-2 Device Name | Proprietary name: Wiener lab. BILIRRUBINA DIRECTA AACommon name: Bilirubin (total or direct) test systemClassification name: Diazo colorimetry Bilirubin |
Device Class II
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- 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.
| DMATest System | WIENER LAB.Test System | |
|---|---|---|
| Intended Use | Quantitativedetermination of directbilirubin in human serum. | Quantitativedetermination of directbilirubin in human serumand heparinized plasma. |
| Continued on next page | ||
| DMATest System | WIENER LAB.Test System | |
| Test Principle | Conjugated billirubinreacts with diazotizedsulfanilic acid to producean acid azobilirubin, theabsorbance of which isproportional to theconcentration of directbilirubin in the samplecan be measured at 550nm. | Direct bilirubin ismeasured using a stabledichlorophenyldiazoniumsalt (DPD) to form a redazocompound in an acidsolution, with maximalO.D. at 546 nm. Theamount of direct bilirubinis determined bymeasuring theabsorbance of thispigment. |
| Reagents | Bilirubin Reagent:hydrochloric acid andsulfanilic acid.Sodium Nitrite Reagent:sodium nitrite. | R1: sulfamic acid.R2: dichlorophenyl-diazonium salt.Reagent for sampleblank: sulfamic acid. |
| Sample | Human serum. | Human serum andheparinized plasma. |
| Wavelength ofReading | 550 nm | Spectrophotometer:546 nmPhotocolorimeter withgreen filter:520 - 550 nm |
| Linearity | 12 mg/dl | 14 mg/dl |
| Expectedvalues | 0.0 — 0.2 mg/dl | |
| Continued on next page | ||
| DMATest System | WIENER LAB.Test System | |
| Within-runprecision | Normal Level Serum:CV = <1% | Normal Level Serum:CV = 4.03% |
| High Level Serum:CV = 2.8% | High Level Serum:CV = 1.33% | |
| Total-runprecision. | Normal Serum Control:CV = 8.8%% | Normal Serum Control:CV = 5.09% |
| Abnormal Serum Control:CV = 4.4% | Abnormal Serum Control:CV = 2.00% |
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6-7 Conclusion Above mentioned data show substantial equivalency to the predicate device.
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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 top half of the circle. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines that suggest the head and wings of the bird.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
FEB 1 2 2003
Dr. Viviana Cetola QC/QA Manager Weiner Laboratorios S.A.I.C. Riobamba 2944 Rosario, Santa Fe Argentina 2000
Re: K024116 Trade/Device Name: Weiner Labs Bilirrubina directa AA Regulation Number: 21 CFR 862.1110 Regulation Name: Bilirubin (total or direct) test system Regulatory Class: Class II Product Code: CIG Dated: November 26, 2002 Received: December 13, 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 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 Sutman
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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| Page of | __________________________________________________________________________________________________________________________________________________________________________ ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
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| 510(k) Number (if known): | K024146 |
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| Device Name: | Wiener lab. |
| Bilirrubina directa AA |
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 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.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IP NEBOBO)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use V (Ter 21 CFR 801.109) OR
Over-The-Counter Use_
(Optional Format 1-2-96)
tan Cooper
(Division Sign-Off) Division of Clinical Laboratory Devices 241 510(k) Number _ 11
§ 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.