← Product Code [CGA](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGA) · K252488 # ABL90 FLEX PLUS System (K252488) _Radiometer Medicals Aps · CGA · May 1, 2026 · Clinical Chemistry · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGA/K252488 ## Device Facts - **Applicant:** Radiometer Medicals Aps - **Product Code:** [CGA](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGA.md) - **Decision Date:** May 1, 2026 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 862.1345 - **Device Class:** Class 2 - **Review Panel:** Clinical Chemistry ## Indications for Use The ABL90 FLEX PLUS System is an in vitro diagnostic, portable, automated analyzer that quantitatively measures: glucose in heparinized capillary whole blood. The ABL90 FLEX PLUS System 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. Glucose (cGlu): Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma. ## Device Story ABL90 FLEX PLUS System is a portable, automated in vitro diagnostic analyzer for quantitative glucose measurement. This submission adds capillary heparinized whole blood (via safeCLINITUBES) to existing arterial/venous sample capabilities. Device uses amperometry; electrical current magnitude at electrode chain is proportional to glucose concentration. Operated by trained clinicians (nurses, physicians, technologists) in lab or point-of-care settings. System includes analyzer, sensor cassette, and solution pack. Output is a quantitative glucose concentration value used by clinicians to diagnose and manage carbohydrate metabolism disorders. Benefits include rapid, point-of-care diagnostic capability for glucose monitoring. ## Clinical Evidence No clinical trials were performed. Evidence consists of analytical performance studies: precision (multi-day, 39 donors, fingerstick samples) and method comparison (CLSI EP09c, 114-116 samples) against a comparator method. Precision showed CV% ranging from 1.60% to 3.21% across glucose intervals. Method comparison demonstrated strong correlation (R² 0.97-1.00) and minimal bias. ## Technological Characteristics Amperometric sensor for glucose measurement. System includes automated sample inlet mechanism for capillary (C65 mode), syringe (S65), and short probe (SP65) modes. Consumables include sensor cassettes and solution packs. Connectivity and software architecture are inherited from previously cleared versions (K240998). ## Regulatory Identification A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma. ## Special Controls *Classification.* Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9. ## Predicate Devices - i-STAT G cartridge with the i-STAT 1 System ([K223755](/device/K223755.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} FDA U.S. FOOD & DRUG ADMINISTRATION # 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY ## I Background Information: A 510(k) Number K252488 B Applicant Radiometer Medicals ApS C Proprietary and Established Names ABL90 FLEX PLUS System D Regulatory Information | Product Code(s) | Classification | Regulation Section | Panel | | --- | --- | --- | --- | | CGA | Class II | 21 CFR 862.1345 - Glucose Test System | CH - Clinical Chemistry | ## II Submission/Device Overview: A Purpose for Submission: Modification to a previously cleared device. B Measurand: Glucose (cGlu) C Type of Test: Amperometry: Glucose Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993-0002 www.fda.gov {1} K252488 - Page 2 of 6 ## III Intended Use/Indications for Use: ### A Intended Use(s): See Indications for Use below. ### B Indication(s) for Use: The ABL90 FLEX PLUS System is an in vitro diagnostic, portable, automated analyzer that quantitatively measures: - glucose in heparinized capillary whole blood. The ABL90 FLEX PLUS System 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. Glucose (cGlu): Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma. ### C Special Conditions for Use Statement(s): Rx - For Prescription Use Only ### D Special Instrument Requirements: ABL90 FLEX PLUS System ## IV Device/System Characteristics: ### A Device Description: The ABL90 FLEX PLUS System consists of the ABL90 FLEX PLUS analyzer, sensor cassette (SC) and solution pack (SP) consumables, and related accessories for the analyzer as described in K240998. The ABL90 FLEX PLUS System has an automated sample inlet mechanism, which can collect arterial and venous whole blood through two different measuring modes: the S65 syringe mode and the SP65 short probe mode, and capillary whole blood through the C65 capillary mode. For the C65 modes, samples are loaded using safeCLINITUBES which are 70 and 100μL plastic capillary tubes with balanced heparin, mixing wires and end caps. This submission is for the addition of capillary heparinized whole blood samples for cGlu. The ABL90 FLEX PLUS System is cleared for the quantitative measurement of pH, pO2, pCO2, oximetry (sO2, ctHb, FO2Hb, FCOHb, FMetHb, FHHb) cK+, cNa+, cCa2+, cCl-, cGlu, and {2} cLac using arterial and venous heparinized whole blood samples (K240998, K241037, K252207). The system is cleared for the quantitative measurement of pH, pCO2, ctHb, Cl-, cK+, cNa+, and cCa2+ using capillary heparinized whole blood sample (K240998, K241037, K252207 and K252475). ## B Principle of Operation: Amperometry: The magnitude of an electrical current that flows through an electrode chain is proportional to the concentration of the substance that is oxidized or reduced at an electrode in the chain. The amperometric measuring principle is applied in the cGlu sensor. ## V Substantial Equivalence Information: A Predicate Device Name(s): i-STAT G cartridge with the i-STAT 1 System B Predicate 510(k) Number(s): K223755 C Comparison with Predicate(s): | Device & Predicate Device(s): | K252488 | K223755 | | --- | --- | --- | | Device Trade Name | ABL90 FLEX PLUS System | i-STAT G cartridge with the i-STAT 1 System | | General Device Characteristic Similarities | | | | Intended Use/Indications For Use | Intended to measure glucose in capillary blood samples | Same | | Intended Use Environment | Laboratory environment, or point-of-care setting | Same | | General Device Characteristic Differences | | | | Reportable Range | 18-738 mg/dL | 20-700 mg/dL | ## VI Standards/Guidance Documents Referenced: Clinical and Laboratory Standards Institute (CLSI) EP05-A3 – Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline – Third Edition K252488 - Page 3 of 6 {3} CLSI EP09c 3rd Edition – Measurement Procedure Comparison and Bias Estimation Using Patient Samples ## VII Performance Characteristics (if/when applicable): ## A Analytical Performance: 1. Precision/Reproducibility: Within Sample Precision - Capillary Mode Fingerstick A multi-day precision study to assess heparinized capillary whole blood sample within-run precision in capillary mode was performed at two sites by at least two POC operators at each site. Capillary whole blood from 39 donors via finger stick puncture from two (2) fingers into 2 safeCLINITUBE capillary tubes was collected. Blood from each capillary pair was analyzed in singlet in capillary mode on one ABL90 FLEX PLUS analyzer. Samples were grouped into subintervals based on their mean values. The results are summarized below. | Parameter (unit) | N | Test interval | Mean | Repeatability | | | --- | --- | --- | --- | --- | --- | | | | | | SD | CV% | | cGlu (mg/dL) | 6 | 65 - <99 | 94.483 | 1.507 | 1.60 | | | 60 | 99 - <200 | 134.82 | 2.433 | 1.81 | | | 12 | 200 - <594 | 231.33 | 7.436 | 3.21 | 2. Linearity: Linearity for cGlu was previously established in K241037. 3. Analytical Specificity/Interference: Interference for cGlu was established in K241037. 4. Assay Reportable Range: The results from the studies support the claimed reportable range: cGlu 18-738 mg/dL 5. Traceability, Stability, Expected Values (Controls, Calibrators, or Methods): Traceability of cGlu is described in K241037. Sample Stability: Capillary samples are intended to be used immediately. K252488 - Page 4 of 6 {4} 6. Detection Limit: Detection limits for cGlu were established in K241037. 7. Assay Cut-Off: Not applicable. B Comparison Studies: 1. Method Comparison with Predicate Device: Method comparison studies were conducted for cGlu using heparinized whole blood capillary samples for testing according to CLSI EP09c. Capillary blood samples (with fewer than 10% contrived) collected across 2 POC sites in 2 safeCLINITUBE capillary tubes, with at least two POC users per site were compared to arterial and venous whole blood specimens tested on a comparator method. Specifically, each capillary whole blood sample was measured once on the candidate device in C65 mode and once on the comparator device. A comparison between the two measurements was performed using linear regression analysis. The regression analyses are summarized below. | Parameter | n | Range Min | Range Max | Intercept | Slope | R² | MDL | Bias at MDL | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | cGlu (vs. Arterial on comparator) (mg/dL) | 114 | 37.2 mg/dL | 684 mg/dL | -0.724 | 1.01 | 1.00 | 65 | 0.02 | | | | | | | | | 200 | 1.57 | | cGlu (vs. Venous on comparator) (mg/dL) | 116 | 15.5 mg/dL | 684 mg/dL | -0.206 | 1.01 | 0.97 | 65 | 0.17 | | | | | | | | | 200 | 0.96 | 2. Matrix Comparison: Not applicable. C Clinical Studies: 1. Clinical Sensitivity: Not applicable. 2. Clinical Specificity: Not applicable. K252488 - Page 5 of 6 {5} 3. Other Clinical Supportive Data (When 1. and 2. Are Not Applicable): Not applicable. D. Clinical Cut-Off: Not applicable. E. Expected Values/Reference Range: The sponsor included reference range information in the labeling. VIII. Proposed Labeling: The labeling supports the finding of substantial equivalence for this device. IX. Conclusion: The submitted information in this premarket notification is complete and supports a substantial equivalence decision. K252488 - Page 6 of 6 --- **Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGA/K252488](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGA/K252488) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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