(81 days)
Not Found
No
The summary describes a standard automated blood gas analyzer and does not mention any AI or ML capabilities in its description, intended use, or performance studies.
No.
The device is an analyzer that measures various parameters in blood, which are then used in the diagnosis and treatment of conditions. It does not directly provide therapy or treatment itself.
Yes
The device measures various blood parameters (pH, blood gases, electrolytes, glucose, lactate, and oximetry) whose measurements "are used in the diagnosis and treatment of life-threatening acid-base disturbances" and "in the diagnosis and treatment of" specific disease conditions. This definition directly aligns with the purpose of a diagnostic device.
No
The device description explicitly states it is a "portable, automated system intended for in vitro testing of samples of whole blood," indicating it is a hardware device that performs physical measurements.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the analyzer "measures pH, blood gases, electrolytes, glucose, lactate, and oximetry in heparinised whole blood." These are all measurements performed on biological samples in vitro (outside the body).
- Device Description: The "Device Description" further clarifies that the system is "intended for in vitro testing of samples of whole blood".
- Indications for Use: The detailed list of indications for each parameter (pH, pO2, pCO2, Potassium, Sodium, etc.) describes how these measurements are used in the diagnosis and treatment of various disease conditions. This aligns with the purpose of IVD devices, which are used to provide information for diagnostic purposes.
The device analyzes biological samples (whole blood) to provide information used in the diagnosis and treatment of diseases, which is the core definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ABL90 FLEX analyzer is a portable, automated analyzer that measures pH, blood gases, electrolytes, glucose, lactate, and oximetry in heparinised 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.
pH, pO2 and pCO2: pH, pCO2 and pO2 measurements are used in the diagnosis and treatment of life-threatening acid-base disturbances.
Potassium (cKT): potassium measurements are used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels.
Sodium (cNa ): sodium measurements are used in the diagnosis and treatment of aldosteronism, diabetes insipsum, adrenal hypertension, Addison's disease, dehydration, inappropriate antidiuretic secretion, or other diseases involving electrolyte imbalance.
Calcium (cCalcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany.
Chloride (cCF): chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such a cystic fibrosis and diabetic acidosis.
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.
Lactate (cLac): The lactate measurements measure the concentration of lactate in plasma. Lactate measurements are used to evaluate the acid-base status and are used in the diagnosis and treatment of lactic acidosis (abnormally high acidity of the blood.)
Total Hemoglobin (ctHb): total hemoglobin measurements are used to measure the hemoglobin content of whole blood for the detection of anemia.
sO2: oxygen saturation, more specifically the ratio between the concentration of oxyhemoglobin and oxyhemoglobin plus reduced hemoglobin.
FO2Hb: oxyhemoglobin as a fraction of total hemoglobin.
FCOHb: carboxyhemoglobin measurements are used to determine the carboxyhemoglobin content of human blood as an aid in the diagnosis of carbon monoxide poisoning.
FMetHb: methemogiobin as a fraction of total hemoglobin.
FHHb: reduced hemoglobin as a fraction of total hemoglobin.
Fraction of Fetal Hemoglobin (FHbF): FHbF indicates the amount of fetal hemoglobin, FHbF is seldom used clinically.
Product codes (comma separated list FDA assigned to the subject device)
CHL, JGS, CEM, JFP, CGZ, CGA, KHP, GKR, GHS, KQI, JJY, JIX
Device Description
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, and co-oximetry parameters (total hemoqlobin, oxygen saturation, and the hemoglobin fractions FO2Hb, FCOHb, FMetHb, FHHb and FHbF).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
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Intended User / Care Setting
use by trained technologists, nurses, physicians and therapists. It is intended for use in a laboratory environment, near patient or point-of-care setting.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Interference Study:
- Sample Size: 1512 measurements (from 6 different pO2 levels plus control, 7 different glucose levels, 3 analyzers, 6 tests of each sample on each analyzer, 2 runs).
- Data Source: fresh heparinized whole blood samples.
- Annotation Protocol: Not Found, but the study evaluated interference at different pO2 and glucose levels.
Precision Study:
- Sample Size: 2160 measurements (over 20 days, 3 different pO2 levels, 3 different glucose levels, 2 tests of each sample each day, 2 runs).
- Data Source: serum pool sample of glucose.
- Annotation Protocol: evaluated according to CLSI guideline "Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline - Second Edition", EP05-A2.
Method Comparison Study:
- Sample Size: approximately 500 samples.
- Data Source: untreated donor samples in combination with spiked donor blood.
- Annotation Protocol: conducted according to NCCLS guideline "Method Comparison and Bias Estimation Using Patient Samples", EP09-A2.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Interference Study:
- Study Type: Interference study.
- Sample size: 1512 measurements.
- Key Results: Bias 10 mmHg when compared to the control) was met.
Precision Study:
- Study Type: Precision study.
- Sample size: 2160 measurements.
- Key Results: CV% 10 mmHg.
Precision Study:
- CV%: ≤ 10%.
Method Comparison Study:
- Slope: 0.9206
- Intercept: 0.084
- R-squared: 0.9895
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 862.1120 Blood gases (P
CO2 , PO2 ) and blood pH test system.(a)
Identification. A blood gases (PCO2 , PO2 ) and blood pH test system is a device intended to measure certain gases in blood, serum, plasma or pH of blood, serum, and plasma. Measurements of blood gases (PCO2 , PO2 ) and blood pH are used in the diagnosis and treatment of life-threatening acid-base disturbances.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the word "RADIOMETER" in bold, black, sans-serif font. To the right of the word is a circled "R" symbol, which is a registered trademark symbol. The text is horizontally aligned and centered.
P 1 7 2013
510(k) Summary
K131988
-
- Administrative
Device Information ABL90 Flex Device Name: Blood gases (pCO2 and pO2) and blood pH test system Common Name:
CHL, JGS, CEM, JFP, CGZ, CGA, KHP, GKR, GHS, KQI, JJY, JIX Product Code: 21 CFR 862.1120, 862.1600, 862.1345, 862.1170, 864.7425, 864.5620, Device Classification: 862.1145, 862.1665, 862.1150, 864.7455, 862.1660, 862.1450 Class II, II, II, II, II, II, II, II, II, II, II, I (reserved), I (limitation to Classification: · exemption per 21 CFR 862.9 (c)(9)), respectively. Clinical Chemistry (75) and Hematology (81) Classification Panel:
Purpose of submission: Introduction of a modification that consists of labeling and software changes that suppress glucose results obtained from samples with pO2 levels below 10mmHg, and to suppress glucose results >270mg/dL obtained from samples with 10mmHg 270 mg/dL, the
linearity is not specified
and the cGlu value not
usable. ≥25 mmHg
(3.3 kPa) 0.5 - 40 mmol/L
(9 - 720 mg/dL) | | | | | | | | |
:
4
.
:
:
:
Traditional 510(k): Modification to ABL90 Flex -Specific cGlu Suppression
| Predicate: ABL90 Flex (K122729) | |
|---|---|
| Similarities | Differences |
| Electrolyte Measurement | |
| cK+, cNa+, cCa2+, cCl- by potentiometry | Software changes: |
- Suppression of glucose results when
pO2 270mg/dL when pO2 is between 10 -
25mmHg - Message: "Glu not usable" |
| Metabolite Measurement
cGlu, cLac by amperometry | |
| Oximetry Measurement
ctHb, sO2 FO2Hb, FHHb, FCOHb, FMetHb,
FHbF | |
| Hemoglobin Measurement
Spectrophotometry | |
| Identical Performance Characteristics | |
| Two-Point liquid calibration | |
| Menu driven touch screen | |
| Software operating system Microsoft XPE | |
| Sample Introduction Aspiration | |
| Dimensions (length x width x depth) | |
| External Power Source
230/120 V mains | |
.
:
.
.
.
5
| 6. Design Control Activities | ||||
|---|---|---|---|---|
| # / Hazard | Validations and Verifications activities descriptions | Pre-determined Acceptance criteria | Testing results summary | Meet the acceptance criteria or not? |
| 41/Too low | ||||
| Glucose result in | ||||
| the upper | ||||
| reportable range | ||||
| obtained from | ||||
| samples with | ||||
| low pO2 level | Interference study at | |||
| different pO2 | ||||
| levels and at | ||||
| different | ||||
| glucose levels | ||||
| covering the | ||||
| reportable | ||||
| range of the | ||||
| analyser | ||||
| using fresh | ||||
| heparinized | ||||
| whole blood | ||||
| samples. | Bias: ≤10% | |||
| for glucose | ||||
| when pO2 is |
10 mmHg
when
compared to
the control | 6 different pO2 levels
- pO2 ≥90 mmHg as control
7 different glucose levels
3 analyzers
6 tests of each sample on each
analyzer
2 runs
Total of 1512 measurements
The results are valid under the
conditions that
- all glucose results are
suppressed when the pO2
level of the sample is below
10 mmHg, and - all glucose results are
suppressed when pO2 level of
the sample is between 10
mmHg and 25 mmHg and the
glucose level is above 270
mg/dL
all acceptance criteria are met:
Bias 90 mmHg | 18.1 | 0.1 | 0.7 | 4.1 | 240 |
| Glu Mid
$98.7 ± 9 mg/dL$ | 10 mmHg | 101.7 | 1.1 | 3.8 | 3.7 | 240 |
| | 30 mmHg | 101.0 | 0.7 | 3.3 | 3.3 | 240 |
| | >90 mmHg | 101.2 | 0.5 | 3.3 | 3.2 | 240 |
| Glu High
$270 ± 6 mg/dL$ | 10 mmHg | 254.1 | 1.6 | 10.8 | 4.2 | 240 |
| | 30 mmHg | 262.3 | 1.1 | 8.8 | 3.4 | 240 |
| | >90 mmHg | 271.9 | 1.7 | 7.4 | 2.7 | 240 |
Method Comparison
Method comparison study versus a comparative analyzer (ABL735) has been conducted according to NCCLS guideline "Method Comparison and Bias Estimation Using Patient Samples", EP09-A2.
This study was an in-house method comparison using untreated donor samples in combination with spiked donor blood where necessary. A total of 52 different donors are used in data mining and approximately 500 samples are measured
Linear regression of the pooled data qives a slope of 0.9206, intercept of 0.084 and an Re ≥ 0.95; fulfilling the requirements to slope (0.9 - 1.1), intercept (0) and correlation coefficient (≥ 0.95)
7
Traditional 510(k): Modification to ABL90 Flex -Specific cGlu Suppression
Image /page/7/Figure/2 description: The image is a scatter plot titled "Average: ABL90 as function of ABL735". The x-axis is labeled "Read out ABL735", and the y-axis is labeled "Read out ABL90". There is a series of data points plotted on the graph, labeled "Series 1", and a dashed line representing y=x. The equation of the trendline is y = 0.9206x + 0.084, with an R-squared value of 0.9895.
Interference
Interference study has been conducted according to CLSI guideline "Interference Testing in Clinical Chemistry; Approved Guideline - Second Edition", EP07-A2.
This study evaluates the pO2 tension in blood samples as an interfering substance to the glucose measurement.
| Results of Interference Study | |||||||
|---|---|---|---|---|---|---|---|
| CV% | |||||||
| (XTEST- | |||||||
| XCONTROL) | pO₂ [mmHg] | 10 | 15 | 20 | 25 | 50 | 80 |
| cGLu [mg/dL] | 9 | 3.3% | 3.1% | 3.4% | 1.1% | 3.8% | 0.0% |
| 36 | 1.3% | 1.3% | 0.8% | 0.5% | 0.9% | 0.2% | |
| 79 | 2.0% | 1.6% | 0.7% | 0.8% | 0.9% | 0.6% | |
| 119 | 2.0% | 1.5% | 1.5% | 0.9% | 1.3% | 0.4% | |
| 180 | 4.7% | 2.7% | 2.5% | 0.9% | 0.3% | 0.6% | |
| 270 | 7.0% | 6.1% | 3.1% | 2.4% | 2.0% | 1.1% | |
| 450 | 13.6% | 9.3% | 7.1% | 3.8% | 5.0% | 0.7% |
6. Performance Data
The performance data submitted in the original submission (K092686) still apply.
7. Conclusion
The ABL90 FLEX with the modification described above is substantially equivalent in Intended Use, fundamental scientific technology, features, and characteristics to the predicate ABL90 Flex (K122729).
8
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 17, 2013
Radiometer Medical ApS C/O Gitte Juel Friis Akandevei 21 2700 Bronshoj DENMARK
Re: K131988
Trade/Device Name: ABL90 Flex Analyzer Regulation Number: 21 CFR 862.1120 Regulation Name: Blood gases (PCO2, PO2) and blood pH test system Regulatory Class: II Product Code: CHL JGS, CEM, JFP, CGZ, CGA, KHP, GKR, GHS, KQI, JJY, JIX Dated: June 24, 2013 Received: June 28, 2013
Dear Mr. Friis:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
9
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Carol C. Benson -S for
Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
10
Indication for Use
510(k) Number (if known): K131988
Device Name: ABL90 Flex Analyzer
Indication For Use:
Intended Use:
The ABL90 FLEX analyzer is a portable, automated analyzer that measures pH, blood gases, electrolytes, glucose, lactate, and oximetry in heparinised 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-ofcare setting. These tests are only performed under a physician's order.
Indications for use:
pH, pO2 and pCO2: pH, pCO2 and pO2 measurements are used in the diagnosis and treatment of life-threatening acid-base disturbances.
Potassium (cKT): potassium measurements are used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels.
Sodium (cNa ): sodium measurements are used in the diagnosis and treatment of aldosteronism, diabetes insipidus, adrenal hypertension, Addison's disease, dehydration, inappropriate antidiuretic secretion, or other diseases involving electrolyte imbalance. .
Calcium (cCalcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany.
Prescription Use (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use _ (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH. Office of In Vitro Diagnostics and Radiological Health (OIR)
Yung WඳChân -S
Division Sign-Off Office of In Vitro Diagnostics and Radiological Health
510(k)K131988
11
Chloride (cCF): chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such a cystic fibrosis and diabetic acidosis.
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.
Lactate (cLac): The lactate measurements measure the concentration of lactate in plasma. Lactate measurements are used to evaluate the acid-base status and are used in the diagnosis and treatment of lactic acidosis (abnormally high acidity of the blood.)
Total Hemoglobin (ctHb): total hemoglobin measurements are used to measure the hemoglobin content of whole blood for the detection of anemia.
sO2: oxygen saturation, more specifically the ratio between the concentration of oxyhemoglobin and oxyhemoglobin plus reduced hemoglobin.
FO2Hb: oxyhemoglobin as a fraction of total hemoglobin.
FCOHb: carboxyhemoglobin measurements are used to determine the carboxyhemoglobin content of human blood as an aid in the diagnosis of carbon monoxide poisoning.
FMetHb: methemogiobin as a fraction of total hemoglobin.
FHHb: reduced hemoglobin as a fraction of total hemoglobin.
Fraction of Fetal Hemoglobin (FHbF): FHbF indicates the amount of fetal hemoglobin, FHbF is seldom used clinically.
And/Or
× Prescription Use (21 CFR Part 801 Subpart D) Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH. Office of In Vitro Diagnostics and Radiological Health (OIR)
YungW.Chan -S
Division Sign-Off Office of In Vitro Diagnostics and Radiological Health
510(k)K131988