ABL80 FLEX Analyzer
510(k) K051804
Active
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK051804 | Date1 Nov 2005 | StatusActive |
Recalls
-
- Terminated Z-2467-2020
Barcode readers on ALB900 and ABL800 analyzers used for measuring pH, blood gases, electrolytes, glucose, lactate, hematocrit and oximetry may misinterpret the contents of some barcode types not using a check digit for patient ID or accession number. Misinterpretation of a barcode, including e.g. patient ID or accession number, may result in patient mix up and/or delayed medical treatment.
-
- Terminated Z-2304-2012
The firm recalled because the glucose measurements from a patient sample that the customer felt was too low and did not reflect the patient's clinical condition.
-
- Terminated Z-1384-2012
The product can cause the analyzer to report values outside the published performance specifications for pH, pCO2, cNa+, cK+, cCa2+ and cCl-.
-
- Terminated Z-1201-2007
The ABL8O FLEX software version 1.10 contains errors in the derived parameter calculation for cBase(B,ox) and cBase(Ecf,ox). These incorrect calculations result in a mild to moderate lowering of the base excess value, the severity depending on the concentration of hemoglobin and the oxygen saturation in the sample. Elevated hemoglobin concentrations have the greatest impact on this calculation err
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- CHL
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.1120
- Advisory Committee
- Clinical Chemistry
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 6 Oct 2026
The ABL80 FLEX Analyzer is a portable, cassette-based system designed for measuring pH, blood gases (Pco2, Po2), electrolytes, glucose, and hematocrit in whole blood. It is classified as an Electrode Measurement, Blood-Gases (Pco2, Po2) and Blood Ph device under FDA device class 2, with product code CHL and regulation number 862.1120. The device received traditional 510(k) clearance (K051804) on November 1, 2005, based on substantial equivalence to a predicate device.
It is intended for use by trained technologists, nurses, physicians, and therapists in decentralized settings such as point-of-care or near-patient testing environments. The system is supplied as a portable analyzer and is designed for use with cassettes. No information regarding sterility, single-use or reusable status, MRI safety, specific sizes, storage conditions, or additional authorizations beyond the FDA 510(k) clearance is provided in the data.
Other devices from Sendx Medical, Inc.
Questions
AI-generated answers, 6 Oct 2026
What is the ABL80 FLEX Analyzer used for?
The ABL80 FLEX Analyzer is designed for measuring pH, blood gases (Pco2, Po2), electrolytes, glucose, and hematocrit in whole blood samples, intended for use by trained healthcare professionals in decentralized settings such as point-of-care or near-patient testing environments.
How is the ABL80 FLEX Analyzer supplied and what does it require for operation?
The system is supplied as a portable analyzer and is designed for use with cassettes; it requires cassettes to perform measurements on whole blood samples, though specific cassette models or supply details are not provided in the data.
What regulatory pathway was used for the ABL80 FLEX Analyzer?
The ABL80 FLEX Analyzer received traditional 510(k) clearance (K051804) from the FDA on November 1, 2005, based on substantial equivalence to a predicate device, and is classified as a Class II device under product code CHL and regulation number 862.1120.