ABL90 FLEX, ABL90 FLEX PLUS

K170882 · Radiometer Medical Aps · MQM · Apr 28, 2017 · Clinical Chemistry

Device Facts

• Record ID: K170882
• Device Name: ABL90 FLEX, ABL90 FLEX PLUS
• Applicant: Radiometer Medical Aps
• Product Code: MQM · Clinical Chemistry
• Decision Date: Apr 28, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1113
• Device Class: Class 1
• Attributes: Pediatric

Indications for Use

ABL90 FLEX: The ABL90 FLEX analyzer is an in vitro diagnostic, portable, automated analyzer that quantitatively measures neonatal bilirubin in heparinized capillary, venous and arterial 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. ABL90 FLEX PLUS: The ABL90 FLEX PLUS analyzer is an in vitro diagnostic, portable, automated analyzer that quantitatively measures neonatal bilirubin in heparinized capillary, venous and arterial whole blood. The ABL90 FLEX PLUS 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 PLUS analyzer are intended to aid in assessing the risk of kernicterus in neonates.

Device Story

Portable, automated in vitro diagnostic analyzer; measures neonatal bilirubin in heparinized capillary, venous, and arterial whole blood. Used in laboratory or point-of-care settings by trained clinicians (technologists, nurses, physicians, therapists). System utilizes sensor cassettes (electrochemical and optical sensors) and a 256-pixel array spectrophotometer for co-oximetry and bilirubin analysis. Input: whole blood sample; Output: quantitative bilirubin measurement. Clinicians use results to assess kernicterus risk in neonates. Device provides rapid, near-patient testing to support clinical decision-making.

Clinical Evidence

Method comparison study conducted at two point-of-care sites using 44 arterial, 42 venous, and 17 spiked cord blood samples. Results showed strong correlation with predicate (ABL835 FLEX). Combined data (n=103) showed slope 0.97, intercept -0.38 mg/dL, R^2=1.00. Arterial samples (n=44) showed slope 0.98, R^2=0.97. Venous samples (n=42) showed slope 0.98, R^2=0.98. Precision, linearity, and detection limits were previously established in K132691.

Technological Characteristics

Portable, automated analyzer. Features miniaturized electrochemical sensors (film technology) and optical oxygen sensors integrated in a sensor cassette. Uses a 256-pixel array spectrophotometer for co-oximetry and bilirubin. Connectivity: point-of-care/laboratory. System includes sensor cassette and solution pack accessories.

Indications for Use

Indicated for neonates (up to one month old) to quantitatively measure bilirubin in heparinized capillary, venous, and arterial whole blood to aid in assessing the risk of kernicterus.

Regulatory Classification

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).

Submission Summary (Full Text)

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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
## TRIAGE-QUICK REVIEW DECISION SUMMARY

510(k) #: k170882

This 510(k) was reviewed under OIR’s Triage-Quick Review Program. This program represents an internal workload management tool intended to reduce internal FDA review resources for 510(k) applications that are of good quality upon receipt by FDA.

The information in the 510(k) is complete and supports a substantial equivalence (SE) determination. Please refer to the applicant’s 510(k) summary for a summary of the information that supports this SE determination.