(569 days)
Not Found
No
The summary describes a standard immunoassay with electrochemical detection and does not mention any AI or ML components in the device description, intended use, or performance studies.
No
The device is an in vitro diagnostic test used to detect ß-hCG, aiding in pregnancy detection, and does not provide therapeutic treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that the i-STAT® Total Beta-Human Chorionic (B-hCG) test is an "in vitro diagnostic test." It's used for the "quantitative and qualitative determination of ß-hCG in venous whole blood or plasma samples," which aids in the "early detection of pregnancy."
No
The device description clearly outlines a physical test using an electrochemical sensor chip and antibodies, which is a hardware component. The summary also describes performance studies involving blood and plasma samples, indicating a physical interaction with biological material, not just software processing.
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 i-STAT® Total Beta-Human Chorionic (B-hCG) test is an in vitro diagnostic test. It also describes its purpose: quantitative and qualitative determination of ß-hCG in biological samples (venous whole blood or plasma) to aid in the early detection of pregnancy. This aligns perfectly with the definition of an IVD, which is a medical device intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state or concerning a congenital abnormality.
- Device Description: The description details the technology used to analyze the biological sample (two-site enzyme-linked immunoassay with electrochemical detection) and the components involved (sensor chip, antibodies, conjugate). This further confirms that the device is designed to perform tests on samples outside of the body.
- Controls and Calibration Verification Materials: The mention of controls and calibration verification materials, which are also described as assayed human serum, is typical for IVD systems to ensure the accuracy and reliability of the test results.
The information provided clearly indicates that this device is designed to perform diagnostic tests on biological samples in a laboratory or point-of-care setting, which is the core function of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The i-STAT® Total Beta-Human Chorionic (B-hCG) test is an in vitro diagnostic test for the quantitative and qualitative determination of ß-hCG in venous whole blood or plasma samples using the i-STAT 1 Analyzer Systems. The test is intended to be used as an aid in the early detection of pregnancy and is for prescription use only.
The i-STAT® Total B-hCG Controls are used to monitor performance of the i-STAT Total β-hCC test.
The i-STAT® Total B-hCG Calibration Verification Materials are used to verify the calibration of the i-STAT Total BhCG test throughout the reportable range.
Product codes (comma separated list FDA assigned to the subject device)
DHA, JJX
Device Description
The i-STAT Total ß-hCG test uses a two-site enzyme-linked immunoassay with electrochemical detection of the resulting enzyme signal. Monoclonal antibodies specific for the ß subunit of hCG are localized within a lithographically defined capture region on the surface of a specially designed electrochemical sensor chip. A separate reference sensor of similar construction to the hCG sensor, but without antibodies specific to hCG, is located on the same sensor chip. An alkaline phosphatase-linked monoclonal antibody conjugate specific to a separate epitope on the ß subunit of the hCG molecule is present in a metered amount on the sensor chip.
The i-STAT Total ß-hCG Controls are assayed human serum which are used to monitor the performance of the i-STAT Total ß-hCG test.
The i-STAT Total ß-hCG Calibration Verification materials are assayed human serum used to verify the calibration of the i-STAT Total β-hCG test throughout the reportable range.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
The indication for use "early detection of pregnancy" is generally applicable to females of childbearing age. The reference ranges were established for females ≥ 18 and 40 years.
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D) / point of care.
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
Precision / Reproducibility:
Whole blood samples: targeted at four hCG concentrations: 5 IU/L, 25 IU/L, Mid level (~800 IU/L) and High level (~1500 IU/L). Tested at three external POC sites.
Plasma samples: targeted at four hCG concentrations: 5 IU/L, 25 IU/L, mid level (~1150 IU/L) and high level (~1875 IU/L). Tested at three external POC sites.
Linearity / Test Measuring Interval:
Evaluated in both whole blood and plasma by mixing different proportions of low and high positive ß-hCG samples. Samples ranged from 5 IU/L to >2000 IU/L.
Limit of Blank (LoB), Limit of Detection (LoD) and Limit of Quantitation (LoQ):
LoB: 195 replicate measurements in plasma and 144 replicate measurements in blood using blank plasma and fresh whole blood ( 40 years were collected and tested at four external sites. Subjects self-reported menopausal status. 95th percentile and 95% confidence interval calculated non-parametrically based on CLSI EP28-A3c.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Blood to Plasma Equivalence:
Study to determine bias between blood and plasma samples. Observed bias to plasma was no greater than 10% across all blood samples tested. This supports equivalence between the two sample types and to the predicate device.
Precision / Reproducibility:
Whole blood: Highest observed upper (total) imprecision at 5 IU/L was 0.81 IU/L. Highest observed (total) imprecision was 7.3 %CV at all other levels.
Plasma: Observed (total) imprecision at 5 IU/L was 1.03 IU/L. Highest observed (total) imprecision was 5.6 %CV at all other levels.
Linearity / Test Measuring Interval:
Whole blood: Bias due to non-linearity was 0.1 IU/L at lowest hCG concentration. Percent non-linearity did not exceed 4.1% across all levels between 10 and ~2000 IU/L.
Plasma: Bias due to non-linearity was -0.1 IU/L at lowest hCG concentration. Percent non-linearity did not exceed 2.3% across all levels between 10 and ~2000 IU/L.
Limit of Blank (LoB), Limit of Detection (LoD) and Limit of Quantitation (LoQ):
LoQ determined to be 5 IU/L compared to WHO hCG 5th IS. For plasma samples with hCG at ~5 IU/L, individual bias ranged from -0.2 to -1.2 IU/L. End-users may obtain individual results > 15% negative bias for plasma samples when hCG concentrations are >5 IU/L.
Method Comparison with Predicate Device:
Plasma samples: y = 1.02x - 0.22, r = 0.99, n = 134
Whole blood samples: y = 0.95x + 2.39, r = 0.99, n = 134
Sample Matrix Comparison:
All Deming regression slopes comparing the sample type investigated with the control (Li-Hep plasma) fell between 0.9 and 1.1, indicating equivalence.
Reference Range:
| Reference Population age (years) | N Subjects | N Whole blood results | N Plasma results | Median (IU/L) | Range (IU/L) | 95th Percentile (IU/L), [95% CI] |
|---|---|---|---|---|---|---|
| ≥ 18 and |
§ 862.1155 Human chorionic gonadotropin (HCG) test system.
(a)
Human chorionic gonadotropin (HCG) test system intended for the early detection of pregnancy —(1)Identification. A human chorionic gonadotropin (HCG) test system is a device intended for the early detection of pregnancy is intended to measure HCG, a placental hormone, in plasma or urine.(2)
Classification. Class II.(b)
Human chorionic gonadotropin (HCG) test system intended for any uses other than early detection of pregnancy —(1)Identification. A human chorionic goadotropin (HCG) test system is a device intended for any uses other than early detection of pregnancy (such as an aid in the diagnosis, prognosis, and management of treatment of persons with certain tumors or carcinomas) is intended to measure HCG, a placental hormone, in plasma or urine.(2)
Classification. Class III.(3)
Date PMA or notice of completion of a PDP is required. As of the enactment date of the amendments, May 28, 1976, an approval under section 515 of the act is required before the device described in paragraph (b)(1) may be commercially distributed. See § 862.3.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 16, 2015
ABBOTT POINT OF CARE, INC. MELISSA ROBINSON ASSOCIATE DIRECTOR OF REGULATORY AFFAIRS 400 COLLEGE ROAD EAST PRINCETON NJ 08540
Re: K133002 Trade/Device Name: i-STAT® Total B-hCG Test, i-STAT® Total β-hCG Controls, i-STAT® Total ß-hCG Calibration Verification Materials Regulation Number: 21 CFR 862.1155 Regulation Name: Human chorionic gonadotropin (hCG) test system Regulatory Class: II Product Code: DHA, JJX Dated: April 9, 2015 Received: April 13, 2015
Dear Ms. Robinson:
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 Parts 801 and 809); 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
1
electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Katherine Serrano -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
2
Indications for Use
510(k) Number (if known) K133002
Device Name
i-STAT Total ß-hCG test i-STAT Total B-hCG Controls and i-STAT Total ß-hCG Calibration Verification Materials
Indications for Use (Describe)
The i-STAT® Total Beta-Human Chorionic (B-hCG) test is an in vitro diagnostic test for the quantitative and qualitative determination of ß-hCG in venous whole blood or plasma samples using the i-STAT 1 Analyzer Systems. The test is intended to be used as an aid in the early detection of pregnancy and is for prescription use only.
The i-STAT® Total B-hCG Controls are used to monitor performance of the i-STAT Total β-hCC test.
The i-STAT® Total B-hCG Calibration Verification Materials are used to verify the calibration of the i-STAT Total BhCG test throughout the reportable range.
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/0 description: The image shows a blue logo of Abbott. The logo is a stylized letter 'a' with a rounded, sans-serif font. The 'a' is enclosed in a square shape, with the top and bottom lines of the square forming the top and bottom of the 'a'. The logo is simple and modern, and the blue color gives it a sense of trustworthiness and reliability.
510(k) Summary i-STAT Total ß-hCG Test
This summary of the 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1900 and CFR 807.92.
The assigned 510(k) number is: K133002
Date Summary prepared:
1. Submitted by:
Abbott Point of Care Inc. 400 College Road East Princeton, NJ 08540 Phone: 609-454-9000 FAX: 609-419-9370
Establishment Registration Number: 2245578
Contact:
Melissa Robinson 400 College Road East Princeton, NJ 08540 Phone: 609-454-9371 Fax: 609-419-9370
2. Identification of the Device:
Device Classification Name: System, Test, Human Chorionic Gonadotropin Device Name: i-STAT Total ß-hCG Test Classification: Class II (regulation number 862.1155) Classification Product Code: DHA
Device Classification Name: Quality Control Material (Assayed and Unassayed) Device Name: i-STAT Total ß-hCG Control Level 1, 2, 3 Classification:Class I (regulation 862.1660) Product Code: JJX
Regulation Description: Quality Control Material (Assayed and Unassayed) Device Name: i-STAT Total ß-hCG Calibration Verification Levels 1, 2, 3 Classification:Class I (regulation 862.1660) Product Code: JJX
Image /page/3/Picture/16 description: The image shows the logo for Abbott. On the left is a blue symbol that resembles a lowercase "a". To the right of the symbol is the name "Abbott" in bold, black letters. Below the name is the phrase "A Promise for Life" in a smaller font.
4
Image /page/4/Picture/0 description: The image shows the logo for Abbott, a healthcare company. The logo is a stylized letter "a" in a sans-serif font. The letter is a solid, light blue color. The logo is simple and modern, and it is easily recognizable.
3. Predicate Device
Predicate Device Name: Abbott ARCHITECT System Total ß-hCG Predicate 510(k) Number: K983424 Regulation Number: Class II (regulation number 862.1155) Classification Product Code: DHA
Predicate Device Name: Cliniqa Beta HCG Control Level 1, 2, 3 Predicate 510(k) Number: K121237 Regulation Description: Quality Control Material (Assayed and Unassayed) Classification: Class 1 (regulation 862.1660) Product Code: JJX
Predicate Device Name: Cliniqa Beta HCG Calibration Verification Control Levels 1, 2, 3 Predicate 510(k) Number: K121237 Regulation Description: Quality Control Material (Assayed and Unassayed) Classification: Class 1 (regulation 862.1660) Product Code: JJX
4. Intended Use/Indications for Use:
The i-STAT® Total Beta-Human Chorionic Gonadotropin (B-hCG) test is an in vitro diagnostic test for the quantitative and qualitative determination of ß-hCG in venous whole blood or plasma samples using i-STAT 1 Analyzer Systems. The test is intended to be used as an aid in the early detection of pregnancy and is for prescription use only.
i-STAT Total ß-hCG Controls are used to monitor the performance of the i-STAT Total ß-hCG test.
i-STAT Total B-hCG Calibration Verification materials are used to verify the calibration of the i-STAT Total B-hCG test throughout the reportable range.
5. Device Description:
The i-STAT Total ß-hCG test uses a two-site enzyme-linked immunoassay with electrochemical detection of the resulting enzyme signal. Monoclonal antibodies specific for the ß subunit of hCG are localized within a lithographically defined capture region on the surface of a specially designed electrochemical sensor chip. A separate reference sensor of similar construction to the hCG sensor, but without antibodies specific to hCG, is located on the same sensor chip. An alkaline phosphatase-linked monoclonal antibody conjugate specific to a separate epitope on the ß subunit of the hCG molecule is present in a metered amount on the sensor chip.
5
Image /page/5/Picture/0 description: The image shows the logo for Abbott, a healthcare company. The logo is a stylized letter 'a' in a solid blue color. The 'a' is designed with rounded corners and a modern, minimalist aesthetic. The logo is simple and recognizable, representing the company's brand identity.
The i-STAT Total ß-hCG Controls are assayed human serum which are used to monitor the performance of the i-STAT Total ß-hCG test.
The i-STAT Total ß-hCG Calibration Verification materials are assayed human serum used to verify the calibration of the i-STAT Total β-hCG test throughout the reportable range.
6. Substantial Equivalence Information:
| Characteristic | Predicate Device
Abbott ARCHITECT | Proposed Device
APOC i-STAT System |
|-----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The ARCHITECT Total β-hCG
Assay is a Chemiluminescent
Microparticle Immunoassay
(CMIA) for the quantitative and
qualitative determination of beta-
human chorionic gonadotropin
(β-hCG) in human serum and
plasma for the early detection of
pregnancy. | The i-STAT® Total Beta-Human
Chorionic Gonadotropin (β-hCG)
test is an in vitro diagnostic test
for the quantitative and
qualitative determination of
βhCG in venous whole blood or
plasma samples. The test is
intended to be used as an aid in
the early detection of pregnancy |
| Assay
Methodology | Two site ELISA | Two site ELISA |
| Capture Site | Heterogenous | Heterogenous |
| Capture
Antibodies | Monoclonal | Monoclonal |
| Label Antibody | Monoclonal | Monoclonal |
| Label | Acridinium | Alkaline Phosphotase |
| Analysis
Sequence | Sequential capture/label | Simultaneous capture/label |
| Analysis Time | 15.6 minutes | 10 minutes |
| Sample Type | Serum or plasma | Whole blood or plasma |
| Enzyme
Detection | Chemiluminescent Microparticle
Immunoassay | Electrochemical |
Comparison with predicate (i-STAT Total β-hCG Cartridge):
Image /page/5/Picture/8 description: The image shows the Abbott logo. The logo consists of a blue stylized letter "a" on the left and the word "Abbott" in bold, black font on the right. Below the word "Abbott" is the phrase "A Promise for Life" in a smaller, lighter font.
6
Image /page/6/Picture/0 description: The image shows a blue logo of Abbott. The logo is a stylized letter 'a' with rounded corners. The 'a' is formed by a thick line that starts at the top left, curves down and to the right, then curves back up and to the left, forming a closed shape. The logo is simple and modern, and the blue color is clean and professional.
The table below describes the features of the i-STAT Total ß-hCG Cartridge and predicate device that are apparently different.
| Analysis of Difference | |
|---|---|
| Detection | The ARCHITECT detects an optical signal from the acridinium label while the i-STAT System detects the enzyme label by reacting with a substrate so as to generate an electrochemically detectable product. |
| Label | Acridinium is a chemiluminescent label while alkaline phosphatase is an enzyme label. |
| Analysis Sequence | The ARCHITECT is an ELISA with sequential capture and labeling while the i-STAT System is a simultaneous ELISA with capture and label occurring in parallel. |
| Sample Type | The ARCHITECT accepts serum or plasma while the i-STAT device is intended for whole blood or plasma specimens. This submission includes a detailed analysis of equivalence between blood and plasma for the i-STAT Total β-hCG test (see section 18.2.4). This data supports the claim of equivalence between blood and plasma. |
| Reportable Range | The ARCHITECT reports from 1.20 IU/L to 225,000.00 IU/L; the i-STAT Total β-hCG test has a reportable range of 5.0 IU/L to 2000.0 IU/L. These devices are intended for the early detection of pregnancy, consistent with a β-hCG result above 25 IU/L1. The reportable ranges for these devices both exceed that necessary for this intended use. |
Image /page/6/Picture/6 description: The image shows the logo for Abbott. The logo consists of a blue stylized letter "a" on the left, followed by the word "Abbott" in bold, black letters. Below the word "Abbott" is the tagline "A Promise for Life" in a smaller, lighter font.
1 Tietz NW, Clinical Guide to Laboratory Tests, 4th Ed. 2006. p. 2160-2161.
7
Image /page/7/Picture/0 description: The image shows a blue logo of Abbott. The logo is a stylized letter 'a' with rounded corners. The logo is simple and modern, and it is likely used to represent the company in a variety of contexts.
Comparison with predicate (i-STAT β-hCG Control and Calibration Verification Material):
| Characteristic | Predicate Device | Proposed Device |
|---|---|---|
| Cliniqa Beta HCG Control Level | ||
| 1, 2, 3 and Cliniqa Beta HCG | ||
| Calibration Verification Controls | ||
| Level 1, 2, 3(K121237) | i-STAT Total β-hCG Controls | |
| and Calibration Verification | ||
| Material | ||
| Intended Use | Cliniqa Beta HCG Control Level | |
| 1, Cliniqa Beta HCG Control | ||
| Level 2, Cliniqa Beta HCG | ||
| Control Level 3 are assayed | ||
| quality control material used to | ||
| monitor the precision Beta HCG | ||
| assays. | i-STAT Total β-hCG Controls | |
| are used to monitor the | ||
| performance of the i-STAT | ||
| Total β-hCG test. | ||
| Cliniqa Beta HCG Calibration | ||
| Verification Controls, level 1, 2, | ||
| and 3 are assayed quality control | ||
| materials used to monitor the | ||
| precision of Beta HCG assays. | i-STAT Total β-hCG | |
| Calibration Verification | ||
| materials are used to verify the | ||
| calibration of the i-STAT Total | ||
| β-hCG test throughout the | ||
| reportable range. | ||
| Matrix | Human serum with added buffer | |
| stabilizers, and purified human | ||
| hormones. | Human serum with added | |
| buffer stabilizers, and purified | ||
| human hormones. | ||
| Form | Liquid | Liquid |
| Open Vial | ||
| Stability | 30 days | 30 days |
| Caution | Human Source Material | Human Source Material |
| Values | Specific for each lot | Specific for each lot |
| Stability | Opened: 30 days at 2-8 °C | |
| Shelf Life: 3 years at 2-8 °C | Opened: 30 days at 2-8 °C | |
| Shelf Life: 3 years at 2-8 °C |
Image /page/7/Picture/5 description: The image shows the logo for Abbott. The logo consists of a blue stylized "a" on the left, followed by the word "Abbott" in a bold, dark font. Below "Abbott" is the tagline "A Promise for Life" in a smaller, lighter font. The logo is clean and professional, conveying a sense of trust and reliability.
8
7. Standard/Guidance Documents
CLSI EP05-A2: Evaluation of Precision Performance of Quantitative Measurement Methods
CLSI EP6-A: Evaluation of the Linearity of Quantitative Measurement Procedures CLSI EP07-A2: Interference Testing in Clinical Chemistry
CLSI EP09-A2: Method Comparison and Bias Estimation Using Patient Samples CLSI EP12-A2: User Protocol for Evaluation of Qualitative Test Performance CLSI EP17-A2: Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures
CLSI C28-A3c: Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory
CLSI I/LA30-A: Immunoassay Interference by Endogenous Antibodies ISO 14971: Medical Devices – Application of Risk Management to Medical Devices
i-STAT Total ß-hCG Cartridge Performance Characteristics: 8.
i-STAT Total ß-hCG test cartridge:
Blood to Plasma Equivalence a)
The i-STAT Total B-hCG test is designed to function using whole blood or plasma at the point of care. To support equivalence to our predicate device the estimated bias between blood and plasma was determined. A bias to plasma of no greater than 10% was observed across all blood samples tested. This data supports the claim of equivalence between the two sample types and equivalence to our predicate device.
b) Precision / Reproducibility
The test is designed to have total imprecision 2000 IU/L. In whole blood, the bias due to non-linearity was found to be 0.1 IU/L at the lowest hCG concentration. The percent non-linearity measured in whole blood did not exceed 4.1% across all levels between 10 and ~2000 IU/L. In plasma, the bias due to nonlinearity was found to be -0.1 IU/L at the lowest hCG concentration. The percent non-linearity measured in plasma did not exceed 2.3% across all levels between 10 and ~2000 IU/L.
d) Limit of Blank (LoB), Limit of Detection (LoD) and Limit of Quantitation (LoQ)
The Limit of Blank (LoB) was determined using blank plasma and fresh whole blood that measured 5 IU/L, the individual recovery results for whole blood ranged from 91.1% to 118.5%, and for plasma samples from 81.8% to 103.3% when compared to WHO hCG 5th IS. For whole blood samples with hCG at a concentration of ~5 IU/L, the individual bias ranged from 0.3 to 1.1 IU/L, and for plasma samples from -0.2 to -1.2 IU/L when compared to WHO hCG 5th IS. End-
Image /page/10/Picture/10 description: The image contains the Abbott logo. On the left is a blue stylized letter 'A'. To the right of the 'A' is the word 'Abbott' in bold, black letters. Below 'Abbott' is the phrase 'A Promise for Life' in a smaller font.
11
Image /page/11/Picture/0 description: The image shows a blue logo of Abbott Laboratories. The logo is a stylized letter 'a' with a rounded, sans-serif font. The 'a' is enclosed in a rectangular shape, creating a modern and minimalist design. The blue color is consistent throughout the logo.
users may obtain individual result > 15% negative bias for plasma samples when hCG concentrations are >5 IU/L.
Image /page/11/Picture/4 description: The image shows the logo for Abbott. The logo consists of a stylized letter "a" in blue, followed by the word "Abbott" in black, bold font. Below the word "Abbott" is the tagline "A Promise for Life" in a smaller, black font.
12
Image /page/12/Picture/1 description: The image shows a stylized, lowercase letter 'a' in a sans-serif font. The 'a' is a solid, light blue color. The letter is designed with a rounded, geometric shape, giving it a modern and clean appearance. The logo is likely associated with a company or brand whose name begins with the letter 'a'.
Percent recovery results were pooled across each hCG concentration.
| Level | Expected
Mean (IU/L) | Observed
Mean (IU/L) | % Recovery or
Absolute Bias |
|-------|-------------------------|-------------------------|--------------------------------|
| 1 | 1936.4 | 1974.6 | 102.0 % |
| 2 | 972.7 | 989.3 | 101.7 % |
| 3 | 644.8 | 677.4 | 105.1 % |
| 4 | 484.2 | 509.5 | 105.2 % |
| 5 | 242.2 | 261.4 | 107.9 % |
| 6 | 121.3 | 128.2 | 105.7 % |
| 7 | 60.6 | 62.9 | 103.8 % |
| 8 | 24.3 | 26.6 | 109.5 % |
| 9 | 5.1 | 5.8 | 0.7 IU/L |
Summary Recovery Performance. Whole Blood
Summary Recovery Performance, Plasma
| Level | Expected
Mean (IU/L) | Observed
Mean (IU/L) | % Recovery or
Absolute Bias |
|-------|-------------------------|-------------------------|--------------------------------|
| 1 | 1972.6 | 1811.5 | 91.8 % |
| 2 | 986.5 | 895.5 | 90.8 % |
| 3 | 657.5 | 622.1 | 94.6 % |
| 4 | 493.3 | 475.0 | 96.3 % |
| 5 | 246.9 | 234.1 | 94.8 % |
| 6 | 123.5 | 109.2 | 88.4 % |
| 7 | 61.8 | 54.5 | 88.2 % |
| 8 | 24.8 | 22.6 | 91.0 % |
| 9 | 5.3 | 4.5 | 0.8 IU/L |
9. i-STAT Total β-hCG Controls and Calibration Verification Performance Characteristics:
The i-STAT Total ß-hCG Control and Calibration Verification materials are manufactured by Cliniqa (K121237). The materials were evaluated and cleared for market use in k12137.
Image /page/12/Picture/10 description: The image contains the logo for Abbott. On the left is a blue stylized letter 'a'. To the right of the logo is the word "Abbott" in a bold, sans-serif font. Below the word "Abbott" is the phrase "A Promise for Life" in a smaller, sans-serif font.
13
Image /page/13/Picture/0 description: The image shows the logo for Abbott, a healthcare company. The logo is a stylized letter "a" in a blue color. The "a" is formed by a thick, rounded line that creates a square shape with a gap in the middle.
10. Comparison Studies:
Method Comparison with Predicate Device a)
Method comparison data were collected following CLSI guideline EP9-A2. Blood samples were collected at the POC at four external sites in heparinized evacuated tubes, and analyzed in duplicate on the i-STAT System. The blood tubes were sent to the laboratory and the plasma portion was separated from the red cells. The plasma portion was tested in duplicate on the i-STAT System and the ARCHITECT system within 6 hours of collection. A total of 134 samples spanning the measuring interval of the i-STAT Total ß-hCG test were collected. The data was evaluated by weighted Deming regression analysis, using the first result of each duplicate measurement, and the results were as follows:
| Plasma samples: | $y = 1.02x - 0.22, r = 0.99, n = 134$ |
|---|---|
| Whole blood samples: | $y = 0.95x + 2.39, r = 0.99, n = 134$ |
b) Sample Matrix Comparison
Sample matrix comparison was conducted based on the recommendations of CLSI guideline EP9-A2. Forty levels of hCG across and beyond the intended measurement interval of the i-STAT Total ß-hCG test were prepared using 40 donor samples and spiking each with a stock solution containing hCG antigen. The study took place over 12 testing days and the samples were run in random order across the measurement interval. Four sample types were investigated; lithium-heparin (Li-Hep) whole blood and plasma and sodium-heparin (Na-Hep) whole blood and plasma. Results of each sample type against the control (Li-Hep plasma) were analyzed. All Deming regression slopes comparing the sample type investigated with the control fell between 0.9 and 1.1.
11. Reference Range:
Lithium heparin whole blood and plasma specimens from 123 apparently healthy. non-pregnant females ≥ 18 and 40 years were collected and tested at four external sites. Subjects self-reported their menopausal status, which was defined as 12 months since last menses.
The 95th percentile and 95% confidence interval were calculated non-parametrically based on CLSI EP28-A3c.
Image /page/13/Picture/12 description: The image shows the logo for Abbott. The logo consists of a stylized blue letter "a" on the left, followed by the word "Abbott" in bold, black letters. Below "Abbott" is the tagline "A Promise for Life" in a smaller, lighter font.
14
Image /page/14/Picture/0 description: The image shows a blue logo of Abbott. The logo is a stylized lowercase letter 'a' with rounded corners. The 'a' is formed by a continuous line that starts at the top, curves down and around to form the body of the letter, and then extends upwards to create the right side of the 'a'. The interior of the 'a' is white, creating a contrast with the blue outline.
| Reference
Population
age (years) | N
Subjects | N
Whole
blood
results | N
Plasma
results | Median
(IU/L) | Range
(IU/L) | 95th Percentile
(IU/L), [95% CI] |
|----------------------------------------|---------------|--------------------------------|------------------------|------------------|-----------------|-------------------------------------|
| ≥ 18 and