(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 = |
§ 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.