(152 days)
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No
The document describes an update to an "Intralipid correction algorithm" which is a standard signal processing or data correction technique, not indicative of AI/ML. There are no mentions of AI, ML, deep learning, neural networks, or related terms.
No.
The device measures various parameters in whole blood for diagnosis and treatment monitoring, but it does not directly administer therapy or provide therapeutic intervention.
Yes
Explanation: The device is explicitly stated to measure various parameters (pH, blood gases, electrolytes, glucose, lactate, and oximetry) that are "used in the diagnosis and treatment of life-threatening acid-base disturbances" and "used to monitor electrolyte balance in the diagnosis and treatment of disease conditions," among other diagnostic applications for specific analytes. This directly aligns with the definition of a diagnostic device.
No
The device description clearly states it is a "portable, automated system" that measures various parameters in whole blood, indicating it is a physical hardware device with integrated software, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the device "measures pH, blood gases, electrolytes, glucose, lactate, and oximetry in heparinised whole blood." It also lists specific clinical conditions that these measurements are used to diagnose and treat. This clearly indicates that the device is intended for testing samples taken from the human body to provide information for diagnostic purposes.
- Device Description: The device description further clarifies that it is "intended for in vitro testing of samples of whole blood". "In vitro" means "in glass" or "outside the body," which is a key characteristic of IVDs.
- Regulatory Context: The presence of a predicate device (K111897 ABL90 Flex) with a K number (indicating a 510(k) submission to the FDA) strongly suggests that this device is regulated as a medical device, and given its function, specifically as an IVD.
Therefore, based on the provided information, the ABL90 FLEX analyzer fits the 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 (cK+): 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 (cCa2): calcium measurements are used in the diagnosis and treatment of . parathyroid disease, a variety of bone diseases, chronic renal disease and tetany.
Chloride (cCI): chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such a cystic fibrosis and diabetic acidosis.
Glucose (cClu): 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: methemoglobin 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
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, calcium, chloride, glucose, lactate, and co-oximetry parameters (total hemoglobin, oxygen saturation, and the hemoglobin fractions FO2Hb, FCOHb, FMetHb, FHHb and FHbF).
The change consists of an update to the Intralipid correction algorithm for Oxi parameters. The purpose of this update is to improve the suppression of Intralipid interference.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
The ABL90 FLEX 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.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
- Study Type: Interference verification study, In-house method comparison study
- Sample Size: between 76 and 282 samples per parameter spanning the measuring range. Between 9 and 25% of the samples had elevated intralipid index values.
- Key Results:
- Interference: Interferences have been determined and specified in the Reference Manual. Pass.
- Method Comparison: 95% confidence intervals for the new algorithm contain part of the predicted bias intervals for the old algorithm at the medical decision points. Pass. Existing method comparison claims still valid.
- Slope and Intercept (Method Comparison):
- For most parameters (ctHb, SO2, FCOHb, FMetHb, FO2Hb, FHHb): Slope = 1.00, Intercept = varies slightly (e.g., -0.10 g/dL, 0.08%, -0.35%, -0.26%, 0.28%, -0.02%), r = 1.00.
- For FHbF: Slope = 0.87, Intercept = -4.24%, r = 0.89.
- All passed acceptance criteria.
- LOQ: LoQs fulfilled acceptance criteria and were not affected by the change. Pass. Existing LoQ claims still valid.
- Bias and Imprecision: 0.56% of measurements affected. In no case was the significance level a below 30% (typically >80%). The a acceptance level is >=5%. This implies equal series mean for current and improved Intralipid algorithm for all the Oxi parameters. Recalculation verified that the acceptance criteria were met. Pass. Existing claims for bias and imprecision obtained in-house are still valid.
- Linearity: Recalculation verified that the acceptance criteria were met. Pass. Existing linearity claims still valid.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K111897 ABL90 Flex
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Special 510(k): ABL90 Flex - Improved Intralipid correction algorithm for Oxi parameters
Section 5. 510(k) Summary
1. Administrative
Device Information
Device Name: ABL90 Flex Common Name: Blood gases and blood pH test system Product Code: CHL (JGS, CEM, JFP, CGZ, CGA, KHP, GKR, GHS, KQI, JJY, JIX) Registration Number: 21 CFR 862.1120 Classification: Class II Classification Panel: Clinical Chemistry
Submitter
Company Name: Radiometer Medical ApS ER Number: 3002807968 Address: Aakandevej 21 2700 Broenshoei Denmark +45 3827 3827 Phone: Fax: +45 3827 2727 Contact person: Soeren Boegestrand e-mail: soren.bogestrand@radiometer.dk
2. Description of Device Modification
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, calcium, chloride, glucose, lactate, and co-oximetry parameters (total hemoglobin, oxygen saturation, and the hemoglobin fractions FO2Hb, FCOHb, FMetHb, FHHb and FHbF).
The change consists of an update to the Intralipid correction algorithm for Oxi parameters. The purpose of this update is to improve the suppression of Intralipid interference.
3. Intended Use
The ABL90 FLEX is a portable, automated analyzer that measures pH, blood gases, electrolytes, glucose, lactate and oximetry in heparinised whole blood. The ABL90 FLEX 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.
4. Substantial Equivalence
The ABL90 FLEX with the Improved Intralipid correction algorithm for Oxi parameters is substantially equivalent in Intended Use, fundamental scientific technology, features, and characteristics to the predicate:
510(k) Number/Device Manufacturer: K111897 ABL90 Flex, Radiometer Medical ApS MAY 0 7 2013
1
Special 510(k):
ABL90 Flex - Improved Intralipid correction algorithm for Oxi parameters
·
| Similarities | ||
|---|---|---|
| Issue | SE Device | Predicate Device (K111897) |
| Intended Use | Same | The ABL90 FLEX is a portable, automated analyzer that |
| measures pH, blood gases, electrolytes, glucose, | ||
| lactate and oximetry in heparinised whole blood. The | ||
| ABL90 FLEX 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. | ||
| Blood Gas | ||
| Measurement | Same | pH, pO2, pCO2 by potentiometry |
| Electrolyte | ||
| Measurement | Same | cK+, cNa+, cCa2+, cCl- by potentiometry |
| Metabolite | ||
| Measurement | Same | cGlu, cLac by amperometry |
| Oximetry | ||
| Measurement | Same | ctHb, sO2, FO2Hb, FHHb, FCOHb, FMetHb, FHbF by |
| spectrophotometry | ||
| Performance | ||
| Characteristics | Same | Identical Performance Characteristics |
| Calibration | Same | Two-Point liquid calibration |
| User Interface | Same | Menu driven touch screen |
| Software operating | ||
| system | Same | Microsoft XPE |
| Sample Introduction | Same | Aspiration |
| Dimensions (height | ||
| x width x depth) | Same | 17.7 x 9.8 x 11.4 in |
| Weight | Same | 11.1 kg |
| Ethernet | Same | 1 x RJ45 connector, |
| 100Base-Tx Fast Ethernet | ||
| USB | Same | Three connectors for USB port |
| Differences | ||
|---|---|---|
| Issue | SE Device | Predicate Device |
| (K111897) | ||
| Software version | Software version 2.6 MR4 | Software version 2.5 MR2 |
| Intralipid correction | ||
| algorithm for Oxi | ||
| parameters | Improved Intralipid correction | |
| algorithm for Oxi parameters | ||
| implemented in Software | ||
| version 2.6 MR4. | - |
2
Special 510(k):
ABL90 Flex - Improved Intralipid correction algorithm for Oxi parameters
5. Performance Data
No performance characteristics are affected by the change. The performance data submitted in the original submission (K092686) still apply except the interference effect from intralipid to oximetry parameters was further reduced. The Reference Manual was updated to reflect the interference changes from intralipid to oximetry parameters.
3
Special 510(k):
ABL90 Flex - Improved Intralipid correction algorithm for Oxi parameter
Summary of Design Control activiti '9
Risk Assessment
We conducted an FMEA risk and mitigated all identified hazards to As Low As Reasonaly Practicable (ALARP) per ISO
14971, and verified software mitigations by using test proto
Performance testin
| Issue | Acceptance
criteria | Verification
method | Result and Pass/fail | Comments |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------|
| Interference | Clinically relevant interferences
must be known and specified in
the labeling. | Verification study
according to EP17-A2 | Interferences have been
determined and specified in the
Reference Manual
Pass | |
| Method
comparison | Method comparison claims must
be unchanged, i.e. 95%
confidence intervals for the new
algorithm must contain part of
the predicted bias intervals for
the old algorithm at the medical
decision points as per EP9-A2. | In-house method
comparison study vs.
previous algorithm
according to EP9-A2
with between 76 and
282 samples per
parameter spanning
the measuring range.
Between 9 and 25% of
the samples had
elevated intralipid
index values. | 95% confidence intervals for the
new algorithm contain part of
the predicted bias intervals for
the old algorithm at the medical
decision points..
Pass. | Existing method
comparison claims
still valid |
RADIOMETER
4
RADIOMETER Special 510(k):
ABL90 Flex - Improved Intralipid correction algorithm for Oxi parameter
面
Parameters for algorithmic correction of intraoperative Flexion/Extension aB190.
| Issue | Acceptance criteria | Verification method | Result and Pass/fail | Comments | ||||
|---|---|---|---|---|---|---|---|---|
| Slope | Intercept | r | Slope | Intercept | r | |||
| Method | ||||||||
| comparison | 0.9-1.1 | $0.975 | In-house method | |||||
| comparison study vs. | ||||||||
| previous algorithm | ||||||||
| according to EP9-A2 | ||||||||
| with between 76 and | ||||||||
| 282 samples per | ||||||||
| parameter spanning | ||||||||
| the measuring range. | 1.00 | -0.10 g/dL | 1.00 | Existing method | ||||
| comparison claims | ||||||||
| still valid | ||||||||
| 0.9-1.1 | $0.975 | 1.00 | 0.08% | 1.00 | ||||
| 0.9-1.1 | $0.975 | 1.00 | -0.35% | 1.00 | ||||
| 0.9-1.1 | $0.975 | 1.00 | -0.26% | 1.00 | ||||
| 0.9-1.1 | $0.975 | 1.00 | 0.28% | 1.00 | ||||
| 0.9-1.1 | $0.975 | 1.00 | -0.02% | 1.00 | ||||
| 0.85- | ||||||||
| 1.15 | $0.85 | Between 9 and 25% of | ||||||
| the samples had | ||||||||
| elevated intralipid | ||||||||
| index values. | 0.87 | -4.24% | 0.89 | |||||
| LOQ | LoQ claims must be unchanged. | Data analysis and | ||||||
| recalculation of | ||||||||
| existing LoQ | ||||||||
| verification data. | LoQs fulfilled acceptance criteria | |||||||
| and were not affected by the | ||||||||
| change. | Existing LoQ | |||||||
| claims still valid | ||||||||
| Pass. | ||||||||
| ctHb | SO2 | FCOHb | FMetHb | FO₂Hb | FHHb | FHbF |
・・
:
5
Special 510(K):
ABRI on FLEX - Improved Intralingual correction algorithm
Special 510(k):
ABL90 Flex - Improved Intralipid correction algorithm for Oxi parameter
RADIOMETER ®
| Issue | Acceptance
criteria | Verification
method | Result and Pass/Fail | Comments |
|-----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|
| Bias and
imprecision (S₀
and CVₓ) | Claims for bias and imprecision
obtained in-house must be
unchanged, i.e. less than or equal
to values specified in section 7 of
the existing Reference Manual. | Data analysis and
recalculation of
existing performance
verification data
obtained in-house.
Hypothesis H0:
$μimproved = μcurrent$ was
tested statistically. | 0.56% of measurements
affected. In no case was the
significance level α below 30%
(typically >80%). The α
acceptance level is ≥5%. This
implies equal series mean for
current and improved Intralipid
algorithm for all the Oxi
parameters. | Existing claims for
bias and
imprecision
obtained in-house
are still valid |
| | | Values for samples
exceeding the index
value initiating the
new correction were
recalculated and bias
and imprecision were
recalculated based on
this and compared
with the existing
claims. | Recalculation verified that the
acceptance criteria were met.
Pass | |
| Issue | Acceptance
criteria | Verification
method | Result and Pass/fail | Comments |
| Linearity | Linearity claims must be
unchanged, ie. the deviations
from linearity must be less than
or equal to existing claims. | Values for samples
exceeding the index
value initiating the
new correction were
recalculated and
deviations from
linearity were
recalculated based on
this and compared
with the existing
claims. | Recalculation verified that the
acceptance criteria were met.
Pass | Existing linearity
claims still valid |
6
0 RADIOMETER
Special 510(k):
ABL90 Flex - Improved Intralipid correction algorithm for Oxi parameter
.
7
Image /page/7/Picture/0 description: The image shows the word "RADIOMETER" in bold, sans-serif font. To the right of the word is a circled "R" symbol, which is a registered trademark symbol. The text and symbol are in black against a white background.
Special 510(k):
ABL90 Flex - Improved Intralipid correction algorithm for Oxi parameters
7. Conclusion
The ABL90 FLEX with the improved Intralipid algorithm described above is substantially equivalent in Intended Use, fundamental scientific technology, and characteristics to the predicate ABL90 Flex (K111897). For the implementation of the change design control principles (risk management, verification and validation) have been applied which indicated that the change is of no impact to the performance of the device.
8
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/8/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The text is in all caps and is written in a sans-serif font.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 7, 2013
Radiometer Medical ApS C/O Søren Bøgestrand Akandevej 21 2700 Brønshøj DENMARK
Re: K123748
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: April 04, 2013 Received: April 08, 2013
Dear Søren Bøgestrand:
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
Page 2- Søren Bøgestrand
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/ucm11:5809.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
Indications for Use
510(k) Number (if known): K123748
Device Name: ABL90 FLEX Analyzer
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-ofcare 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 (cK+): 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 (cCa2): calcium measurements are used in the diagnosis and treatment of . parathyroid disease, a variety of bone diseases, chronic renal disease and tetany.
Prescription Use X (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)
And/Or
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Yung-W.Chan-S
Division Sign-Off Office of In Vitro Diagnostics and Radiological Health
K123748 510(k)
11
Chloride (cCI): chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such a cystic fibrosis and diabetic acidosis.
Glucose (cClu): 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: methemoglobin 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.
Prescription Use X (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 (OR)
YungWChan -S
Division Sign-Off Office of In Vitro Diagnostics and Radiological Health
K123748 510(k)