(271 days)
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No
The summary describes a standard immunoassay for detecting hCG levels and does not mention any AI or ML components. The performance studies are based on traditional analytical methods.
No
This device is an immunoassay system designed to quantitatively determine total BhCG levels, as an aid in the early detection of pregnancy. It is a diagnostic tool, not a therapeutic device that treats or prevents a disease.
Yes
This device is intended for the quantitative determination of total BhCG levels, which is used as an aid in the early detection of pregnancy. This constitutes providing information to aid in diagnosis.
No
The device description explicitly states that the system comprises the assay, calibrators, and the Access Immunoassay analyzers, indicating the presence of hardware components (the analyzers).
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "quantitative determination of total BhCG levels in human serum and plasma" and is "intended for use as an aid in the early detection of pregnancy." This involves testing biological samples (serum and plasma) in vitro (outside the body) to provide diagnostic information.
- Device Description: It describes an "immunoassay" system that measures a substance (BhCG) in human samples. Immunoassays are a common type of IVD.
- Performance Studies: The document details various performance studies like Method Comparison, Imprecision, Linearity, Limit of Detection, Analytical Specificity, etc. These are standard tests performed to validate the performance of an IVD.
- Predicate Device: It lists a predicate device which is also an "immunoassay" for "Total hCG Assay," further indicating its classification as an IVD.
All these points align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Access Total (BhCG (5th IS) assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of total BhCG levels in human serum and plasma using the Access Immunoassay Systems. The assay is intended for use as an aid in the early detection of pregnancy.
The Access Total BhCG (5th IS) calibrators are intended to calibrate the Access Total BhCG (5" IS) assay for the quantitative determination of total BhCG levels in human serum and plasma using the Access Immunoassay Systems.
Product codes (comma separated list FDA assigned to the subject device)
DHA, JIX
Device Description
The Access Total βhCG (5" IS) assay (standardized to WHO 5" International Standard), Access Total BhCG (5th IS) calibrators, and the Access Immunoassay analyzers comprise the Access Immunoassay System for the quantitative determination of total βhCG in human serum and plasma.
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
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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)
Method Comparison: A comparison of 224 serum samples with hCG concentrations ranging from approximately 3.2 to 1095.9 mIU/mL were run on both the Access Total BhCG (5th IS) immunoassay and the predicate Siemens ADVIA Centaur Total hCG immunoassay. The results were compared using Passing-Bablok regression and Pearson correlation with the predicate on the x-axis. The observed linear fit had a slope = 1.04 with 95% confidence interval of 1.02 to 1.06, an intercept = 2.87 mIU/mL and a r = 0.99.
Imprecision: Serum and plasma samples within run imprecision ranged from 1.8 to 4.8 %CV, between run imprecision ranged from 0.9 to 6.0 %CV, and total imprecision ranged from 2.6 to 6.6 %CV at levels between 3.9 and 1350 mlU/mL. The assay exhibits total imprecision of less than 10% CV for concentrations greater than 3.9 mIU/mL 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 Beckman Coulter. The logo consists of a circular graphic on the left and the words "BECKMAN" and "COULTER" stacked on top of each other on the right. The circular graphic appears to have a stylized design within it, possibly representing a fluid or wave pattern.
510(k) Summary Prepared September 30, 2013
This summary of 510(k) safety and effectiveness is being submitted in accordance with the requirements of 21 CFR 807.92.
Submitter's Name and Address
Beckman Coulter, Inc. 1000 Lake Hazeltine Drive Chaska, MN 55318
Primary Contact: Geraldine Baglien (952) 368-7645 (952) 368-7610 (fax)
Alternate Contact: Jeffrey Koll (952) 368-1361 (952) 368-7610 (fax)
Device Name
| Trade Name: | Access Total βhCG (5th IS) Assay and Access Total
βhCG (5th IS) Calibrators on the Access®
Immunoassay Systems |
|----------------------|----------------------------------------------------------------------------------------------------------------------|
| Common Name: | Human chorionic gonadotropin |
| Classification Name: | Human chorionic gonadotropin (HCG) test system
(21 CFR 862.1155)
Secondary Calibrator (21CFR 862.1150) |
Predicate Device
ADVIA Centaur Total hCG Assay (K925277) Manufactured by Siemens Healthcare Diagnostics, Inc.
OCT 0 1 2013
1
Device Description
The Access Total βhCG (5" IS) assay (standardized to WHO 5" International Standard), Access Total BhCG (5th IS) calibrators, and the Access Immunoassay analyzers comprise the Access Immunoassay System for the quantitative determination of total βhCG in human serum and plasma.
Intended Use
The Access Total (ShCG (5th IS) assay is a paramagnetic particle, chemiluminescent immunoassay for the in vitro quantitative determination of total βhCG levels in human serum and plasma using the Access Immunoassay Systems. This assay is intended for use as an aid in the early detection of pregnancy.
The Access Total βhCG (5th IS) Calibrators are intended to calibrate the Access Total BhCG (5" IS) assay for the quantitative determination of total BhCG levels in human serum and plasma using the Access Immunoassay Systems.
2
Comparison of Technological Characteristics
| Parameter | Access Total BhCG (50" IS) | Predicate ADVIA Centaur Total |
|---|---|---|
| Assay and Access Total BhCG | hCG | |
| (5th IS) Calibrators | ||
| Intended use | The Access Total BhCG (5th IS) | |
| assay is a paramagnetic particle, | ||
| chemiluminescent immunoassay | ||
| for the quantitative determination | ||
| of total BhCG levels in human | ||
| serum and plasma using the | ||
| Access Immunoassay Systems. | ||
| This assay is intended for use as | ||
| an aid in the early detection of | ||
| pregnancy. | ||
| The Access Total BhCG (5th IS) | ||
| Calibrators are intended to | ||
| calibrate the Access Total BhCG | ||
| (5" IS) assay for the quantitative | ||
| determination of total BhCG levels | ||
| in human serum and plasma using | ||
| the Access Immunoassay | ||
| Systems | For in vitro diagnostic use in the | |
| quantitative determination of | ||
| human chorionic gonadotropin | ||
| (hCG) in serum using the ADVIA | ||
| Centaur and ADVIA Centaur XP | ||
| systems. The results obtained from | ||
| hCG specimens are used as an aid | ||
| in the assessment of pregnancy | ||
| status. The assay detects the | ||
| intact hCG molecule and free beta- | ||
| subunit of the hCG molecule | ||
| Analyte Measured | Total BhCG (intact hCG and free | |
| beta-subunit) | Intact hCG and free beta-subunit | |
| hCG | ||
| Standardization | WHO 50 International Reference | |
| Preparation, Chorionic | ||
| Gonadotropin, NIBSC Coded | ||
| 07/364 | WHO 4th International Reference | |
| Preparation, Chorionic | ||
| Gonadotropin, NIBSC Coded | ||
| 75/589 | ||
| Technology | Sandwich immunoassay | Sandwich immunoassay |
| Format | Chemiluminescent | Chemiluminescent |
| Method | Automated | Automated |
| Calibration | Utilizes a stored calibration curve | Utilizes a stored calibration curve |
| Calibrator Levels | 6 levels | |
| (0 mlU/mL, and approximately 6, | ||
| 35, 195, 620 and 1350 mlU/mL) | 2 levels | |
| (Low at approximately 7 mIU/mL | ||
| and High at approximately 300 | ||
| mlU/mL) | ||
| Calibrator Matrix | Bovine serum albumin | Equine serum |
| Calibration Curve | ||
| Stability | 28 days | 28 days |
| Sample Type | Serum or plasma | Serum |
| Measuring Range | 0.6 - 1350 mIU/mL (IU/L) | 2.0 - 1000 mIU/mL (IU/L) |
3
Summary of Studies
Method Comparison: A comparison of 224 serum samples with hCG concentrations ranging from approximately 3.2 to 1095.9 mIU/mL were run on both the Access Total BhCG (5th IS) immunoassay and the predicate Siemens ADVIA Centaur Total hCG immunoassay. The results were compared using Passing-Bablok regression and Pearson correlation with the predicate on the x-axis. The observed linear fit had a slope = 1.04 with 95% confidence interval of 1.02 to 1.06, an intercept = 2.87 mIU/mL and a r = 0.99.
Imprecision: Serum and plasma samples within run imprecision ranged from 1.8 to 4.8 %CV, between run imprecision ranged from 0.9 to 6.0 %CV, and total imprecision ranged from 2.6 to 6.6 %CV at levels between 3.9 and 1350 mlU/mL. The assay exhibits total imprecision of less than 10% CV for concentrations greater than 3.9 mIU/mL and