← Product Code [CGA](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGA) · K151639

# ABL80 FLEX and ABL80 FLEX CO-OX (K151639)

_Sendx Medical, Inc. · CGA · Dec 7, 2015 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGA/K151639

## Device Facts

- **Applicant:** Sendx Medical, Inc.
- **Product Code:** [CGA](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGA.md)
- **Decision Date:** Dec 7, 2015
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.1345
- **Device Class:** Class 2
- **Review Panel:** Clinical Chemistry

## Indications for Use

The ABL80 FLEX analyzer is a portable, automated analyzer that measures glucose, in whole blood. The ABL80 FLEX analyzer 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. The ABL80 FLEX CO-OX analyzer is a portable, automated analyzer that measures glucose, in whole blood. The ABL80 FLEX CO-OX analyzer 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. For in vitro diagnostic use.

## Device Story

Portable, automated analyzers (ABL80 FLEX/ABL80 FLEX CO-OX) measure whole blood glucose via amperometric sensing; requires oxygen for enzymatic glucose conversion. Device monitors sample pO2 levels simultaneously; software automatically suppresses/flags glucose results when pO2 is insufficient for accurate measurement. Used in laboratory or point-of-care settings by trained clinicians. Output provided to clinicians for diagnostic decision-making. Modification ensures reporting limitations based on pO2-dependent glucose linearity ranges (36-180 mg/dL for pO2 20-40 mmHg; 36-270 mg/dL for pO2 ≥41 mmHg).

## Clinical Evidence

No clinical data. Bench testing only. Interference study performed per CLSI EP7-A2 using whole blood samples tonometered to varying pO2 levels (control 100 mmHg vs. test levels). Bias calculated against control; acceptance criterion ≤10%. Results confirmed glucose measurement dependency on pO2, establishing validated linearity ranges.

## Technological Characteristics

Portable, automated analyzer; amperometric sensing principle; two-point liquid calibration; sensor cassette and solution pack accessories; software-controlled parameter reporting based on pO2 levels.

## 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

- ABL800 FLEX analyzer ([K043218](/device/K043218.md))

## Submission Summary (Full Text)

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>
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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION SUMMARY
ASSAY ONLY TEMPLATE

A. 510(k) Number:
k151639

B. Purpose for Submission:
To modify the software to incorporate limitations of reporting glucose results when pO₂ value is low.

C. Measurand:
Whole Blood Glucose

D. Type of Test:
Amperometric Test

E. Applicant:
SenDx Medical, Inc.

F. Proprietary and Established Names:
ABL80 FLEX and ABL80 FLEX CO-OX

G. Regulatory Information:
1. Regulation section:
862.1345
2. Classification:
Class II
3. Product code:
CGA

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4. Panel:
Clinical Chemistry

H. Intended Use:

1. Intended use(s):
See indications for use below

2. Indication(s) for use:
The ABL80 FLEX analyzer is a portable, automated analyzer that measures glucose, in whole blood. The ABL80 FLEX analyzer 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.

The ABL80 FLEX CO-OX analyzer is a portable, automated analyzer that measures glucose, in whole blood. The ABL80 FLEX CO-OX analyzer 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.

For in vitro diagnostic use.

3. Special conditions for use statement(s):
For prescription use only

4. Special instrument requirements:
ABL80 FLEX and ABL80 FLEX CO-OX Analyzers

I. Device Description:
The ABL80 FLEX and ABL80 FLEX CO-OX analyzers are portable, automated systems intended for in vitro testing of samples of whole blood for the parameters pH, pO₂, pCO₂, potassium, sodium, calcium, chloride, glucose, hematocrit (ABL80 FLEX analyzer only) and the oximetry parameters (ABL80 FLEX CO-OX only) total hemoglobin, oxygen saturation, FO₂Hb, FCOHb, FMetHb, and FHHb.

The ABL80 FLEX and ABL80 FLEX CO-OX analyzers each exist in two different software configurations differing in the number of parameters available.

The ABL80 FLEX and ABL80 FLEX CO-OX analyzers consist 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 include models for different

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parameter combinations. For each parameter combination, models allowing for different test loads are available. The solution pack is available in four models, one model for each of the four different configurations of the analyzer.

The ABL80 FLEX and ABL80 FLEX CO-OX analyzers were previously cleared in k051804 and k080370. The current modification to the glucose measurement software is to automatically handle certain glucose results depending on the  $\mathrm{pO}_2$  value in the sample. This will allow incorporating limitations of reporting glucose results when the  $\mathrm{pO}_2$  value of the sample is low.

# J. Substantial Equivalence Information:

1. Predicate device name(s): ABL800 FLEX
2. Predicate 510(k) number(s): k043218
3. Comparison with predicate:

|  Item | Candidate Device ABL80 FLEX and ABL80 FLEX CO-OX | Predicate ABL800 FLEX (k043218)  |
| --- | --- | --- |
|  Intended Use | The ABL80 FLEX and ABL80 FLEX CO-OX analyzers are portable, automated analyzer that measures glucose in whole blood. | Same, plus the following parameters: pH, pO2, pCO2, potassium, sodium, calcium, chloride, glucose, lactate, total bilirubin, and co-oximetry parameters (total hemoglobin, oxygen saturation, and the hemoglobin fractions FO2Hb, FCOHb, FMetHb, FHHb and FHbF)  |
|  Intended Use Site | Laboratory and Point of Care | Laboratory  |
|  Measuring Method | Amperometric | Same  |
|  Calibration Method | Two-point liquid calibration | Same  |
|  Glucose measuring range | 36-180 mg/dL (pO2 between 20 - 40 mmHg); 36-270 mg/dL (pO2 ≥ 41 mmHg). | 36-270 mg/dL  |

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K. Standard/Guidance Document Referenced (if applicable):

CLSI EP7-A2: Interference testing in clinical chemistry; Approved Guideline – Second Edition (2005).

CSLI EP05-A2: Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline – Second Edition (2004).

CSLI EP6-A: Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach; Approved Guideline (2003).

CLSI EP09-A3: Measurement procedure comparison and bias estimation using patient samples; Approved Guideline - Third Edition (2013).

CLSI EP17-A2: Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline – Second Edition (2012).

L. Test Principle:

The amperometric test principle is used for the measurement of both pO₂ and glucose because glucose measurement is dependent upon enough pO₂ in the sample; therefore, pO₂ and glucose are measured simultaneously. The magnitude of an electric flow of current is proportional to the concentration of the substance being oxidized or reduced at an electrode.

M. Performance Characteristics (if/when applicable):

1. Analytical performance:

a. Precision/Reproducibility:
See k051804 and k080370.

b. Linearity/assay reportable range:
See k051804 and k080370.

c. Traceability, Stability, Expected values (controls, calibrators, or methods):
See k051804 and k080370.

d. Detection limit:
See k051804 and k080370.

e. Analytical specificity:

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Analytical Specificity for glucose measurement was reviewed and cleared in k051804 and k080370. However, additional studies were conducted to further characterize the impact of, or interference from, limitations on the amounts of oxygen in the sample. The cause of this interference effect is that the enzymatic conversion of glucose in the sensor is oxygen consuming, the oxygen coming from the sample. The interference study was performed according to the CLSI "Interference testing in clinical chemistry; Approved Guideline - Second Edition", CLSI document EP7-A2. Testing was performed on three ABL80 FLEX and three ABL80 FLEX CO-OX instruments with five levels of glucose and four levels of  $\mathsf{pO}_2$ . Base pools of whole blood were prepared for each glucose level and split into two samples with one being tonometered to  $100\mathrm{mmHg}$ $\mathsf{pO}_2$  (control sample) and the other to the  $\mathsf{pO}_2$  level being tested (test sample). Each sample was tested on the ABL80 FLEX and ABL80 FLEX CO-OX analyzers, and the glucose bias for each test sample vs. the control sample was calculated. The bias for the test sample was calculated and should be less than or equal to the acceptance criterion which was set to  $10\%$  of the control value. Results are summarized below:

ABL80 FLEX:

|  Glucose Concentration (mg/dL) | pO2mmHg  |   |   |   |
| --- | --- | --- | --- | --- |
|   |  < 20 | 20 | 40 | 80  |
|  270 | -67% | -17% | -5% | 1%  |
|  180 | -51% | -3% | 9% | -1%  |
|  90 | -37% | -7% | -6% | 0%  |
|  54 | -26% | -10% | 6% | 1%  |
|  36 | Not needed | -7% | -4% | 2%  |

ABL80 FLEX CO-OX:

|  Glucose Concentration (mg/dL) | pO2mmHg  |   |   |   |
| --- | --- | --- | --- | --- |
|   |  < 20 | 20 | 40 | 80  |
|  270 | -69% | -20% | 3% | 0%  |
|  180 | -55% | -4% | 8% | 0%  |
|  90 | -42% | -8% | -7% | -2%  |
|  54 | -31% | -9% | 6% | 0%  |
|  36 | Not needed | -9% | -4% | 2%  |

The interference study test results support the glucose linearity ranges shown below and documented in the labeling:

Glucose linearity versus  $\mathsf{pO}_2$  level

|  pO2(mmHg) range | Glucose concentration (mg/dL) linearity range  |
| --- | --- |
|  20 – 40 | 36 – 180  |
|  ≥ 41 | 36 – 270  |

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The labeling (reference manual and owner's manual) highlights awareness of dependency of glucose measurement on sample pO₂ levels and includes the following description for flagging glucose results outside the validated glucose linear range and the pO₂ level of the sample:

- All glucose results at pO₂ level &lt;20 mmHg are suppressed and flagged by the symbol “&gt;” with a message “Glu not usable. pO₂ too low for reliable cGlucose measurement”.
- All glucose results &gt;180 mg/dL at pO₂ level between 20 – 40 mmHg will be suppressed and flagged by the symbol “&gt;” with a message “Glu not usable. pO₂ too low for reliable cGlucose measurement”.
- When the measured value of pO₂ is not numeric (Not Reportable (N/R)) or pO₂ parameter is Lockout (P/L) or Not Derived (N/D) or Inactive (I/A) or QC Lockout (L/O), then the results for glucose measurement will not be displayed and the symbol “N/R” is displayed.
- If the results are outside the test range of the analyzer for glucose measurement (see table above), the results are highlighted in red and flagged with “↑” or “↓”.

f. Assay cut-off:

Not applicable

2. Comparison studies:

a. Method comparison with predicate device:

See k051804 and k080370.

b. Matrix comparison:

Not applicable

3. Clinical studies:

a. Clinical Sensitivity:

Not applicable

b. Clinical specificity:

Not applicable

c. Other clinical supportive data (when a. and b. are not applicable):

Not applicable

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4. Clinical cut-off:
Not applicable

5. Expected values/Reference range:
The glucose reference range for adults' arterial blood at 37 °C is 70.02 – 104.9 mg/dL (3.89 – 5.83 mmol/L)
Reference: Tietz NW, Logan NM. Reference ranges. In: Tietz NW, ed. Fundamentals of clinical chemistry. 3rd ed. Philadelphia: WB Saunders Company, 1987: 944-75.

N. Proposed Labeling:
The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.

O. Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGA/K151639](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGA/K151639)

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