(442 days)
The ABL90 FLEX analyzer is an in vitro diagnostic, portable, automated analyzer that quantitatively measures neonatal bilirubin in heparinised capillary whole blood. The ABL90 FLEX analyzer is intended for use by trained technologists, nurses, physicians and therapists. It is intended for use in a laboratory environment, near patient or point-of-care setting. These tests are only performed under a physician's order. Bilirubin measurements on the ABL90 FLEX analyzer are intended to aid in assessing the risk of kernicterus in neonates.
The ABL90 FLEX is a portable, automated system intended for in vitro testing of samples of whole blood for the parameters pH, pO2, pCO2, potassium, sodium, chloride, glucose, lactate, neonatal bilirubin and co-oximetry parameters (total hemoglobin, oxygen saturation, and the hemoglobin fractions FO2Hb, FCOHb, FMetHb, FHHb and FHbF). The ABL90 FLEX consists of an instrument with a sensor cassette and a solution pack as the main accessories. Multiple models of sensor cassettes are available. The various sensor cassette models for different parameter combinations. For each parameter combination, models allowing for different test load are available. The solution pack is available in one model. The ABL 90 FLEX electrochemical sensors are miniaturized, manufactured by film technology and integrated in a common sensor cassette. Likewise, the ABL90 FLEX optical oxygen sensor is integrated in the sensor cassette. A 256-pixel array spectrophotometer is used for the co-oximetry parameters and bilirubin.
Here's a breakdown of the acceptance criteria and study information for the ABL90 FLEX device, based on the provided FDA 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance:
| Performance Characteristic | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Precision (Repeatability & Device/Method Precision) | Acceptable precision in POC and laboratory settings, and in both capillary and syringe mode. | Aqueous Solutions (20-day pooled): |
- Capillary mode: Total %CV from 1.4% to 3.8%
- Syringe mode: Total %CV from 1.3% to 4.6%
Spiked Adult Whole Blood (1-day pooled): - Capillary mode: Total %CV from 1.6% to 14.0%
- Syringe mode: Total %CV from 1.0% to 8.7%
Spiked Adult Whole Blood & Cord Blood (1-day lab): - Capillary mode: Total %CV from 1.1% to 7.7% for adult, 0.9% to 7.4% for cord. |
| Method Comparison (vs. Predicate ABL800 FLEX) | Good correlation with the predicate device and very good agreement between the two modes. | Syringe mode (pooled): Slope = 0.9903 (95% CI: 0.975-1.005), Intercept = 0.6574, R² = 0.9878
Capillary mode (pooled): Slope = 0.9760 (95% CI: 0.961-0.991), Intercept = 0.7741, R² = 0.9861 |
| Linearity | Linear over the entire measuring range and fulfills requirements for allowable error due to non-linearity. | Linear (first order) over the entire measuring range. R² = 0.9996 for Bilirubin: ABL90 vs. Sample Conc. |
| Interference (Non-Significant) |
§ 862.1113 Bilirubin (total and unbound) in the neonate test system.
(a)
Identification. A bilirubin (total and unbound) in the neonate test system is a device intended to measure the levels of bilirubin (total and unbound) in the blood (serum) of newborn infants to aid in indicating the risk of bilirubin encephalopathy (kernicterus).(b)
Classification. Class I.