(174 days)
The Access Total BhCG (5th IS) assay is a paramagnetic particle, chemiluminescent immunoassay for the 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) assay is a paramagnetic particle, chemiluminescent immunoassay for the 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.
Here's a breakdown of the acceptance criteria and study information for the Access Total βhCG (5th IS) device, based on the provided FDA 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Test/Characteristic | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Method Comparison | R² ≥ 0.90 and slope 1.00 ± 0.10 | Met acceptance criteria (R² and slope not explicitly stated, but deemed met) |
| Bias Estimate | Reference intervals on Access 2 system not appreciably changed on Dxl 9000 system | Supports reference intervals have not changed appreciably |
| Imprecision | N/A (criteria not explicitly stated for all ranges) | Within-laboratory (total) % CV ranged from 2.5% to 4.7% for hCG concentrations > 3.9 mIU/mL |
| Within-laboratory (total) SD ranged from 0.04 to 0.06 for hCG concentrations ≤ 3.9 mIU/mL | ||
| Linearity | Non-linearity within ± 0.39 mIU/mL for values ≤ 3.9 mIU/mL | Met acceptance criteria (non-linearity within specified ranges) |
| Non-linearity within ± 10.0% for values > 3.9 mIU/mL | Met acceptance criteria | |
| Reproducibility | SD ≤ 0.51 for values ≤ 3.9 mIU/mL | Met design input requirements (SD ≤ 0.51 for values ≤ 3.9 mIU/mL) |
| CV < 13.0% for values > 3.9 mIU/mL | Met design input requirements (CV < 13.0% for values > 3.9 mIU/mL) | |
| Limit of Blank (LoB) | N/A (result provided as estimate) | LoB estimate of 0.1 mIU/mL |
| Limit of Detection (LoD) | N/A (result provided as estimate) | LoD estimate of 0.2 mIU/mL |
| Limit of Quantitation (LoQ) | 20% CV AND recovery of ± 0.1 mIU/mL for three reagent lots (when compared to WHO 5th International Standard) | LoQ determined to be 0.6 mIU/mL (IU/L) |
2. Sample Size and Data Provenance for Test Set
The document does not explicitly state the specific sample sizes used for each test (e.g., Method Comparison, Imprecision, Linearity, Reproducibility, LoB/LoD/LoQ). It discusses general results of "studies" but doesn't provide granular details on the number of samples or specimens.
The document does not specify the country of origin of the data or whether the studies were retrospective or prospective.
3. Number of Experts and Qualifications for Ground Truth
Not applicable. This device is an in vitro diagnostic (IVD) immunoassay for the quantitative determination of total βhCG levels. The ground truth for such devices is typically established through analytical methods and reference standards, not through expert human interpretation of images or clinical cases.
4. Adjudication Method for Test Set
Not applicable. As this is an IVD immunoassay, an "adjudication method" involving human experts (like 2+1 or 3+1 for clinical case interpretation) is not relevant. The performance is assessed against analytical criteria and reference standards.
5. MRMC Comparative Effectiveness Study
Not applicable. This is an in vitro diagnostic (IVD) device, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant to this submission.
6. Standalone (Algorithm Only) Performance
Yes, the studies described (Method Comparison, Imprecision, Linearity, Reproducibility, LoB/LoD/LoQ) demonstrate the standalone performance of the Access Total βhCG (5th IS) assay on the DxI 9000 Access Immunoassay Analyzer. These are analytical performance characteristics of the device itself, without human-in-the-loop interpretation.
7. Type of Ground Truth Used
The ground truth for the analytical performance studies (such as LoQ determination) was established by comparison to the WHO 5th International Standard for Chorionic Gonadotropin (NIBSC Code 07/364). This is a recognized international reference standard.
8. Sample Size for Training Set
Not applicable. This is an immunoassay, which does not typically involve a "training set" in the context of machine learning algorithms. Its design and calibration are based on chemical principles and validation against reference materials.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no "training set" in the machine learning sense for this device. The ground truth for ensuring the device's accuracy and performance is established through rigorous analytical verification using reference standards like the WHO International Standard.
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December 27, 2022
Beckman Coulter, Inc. Kate Oelberg Senior Staff Quality and Regulatory Affairs 1000 Lake Hazeltine Drive Chaska, Minnesota 55318
Re: K221990
Trade/Device Name: Access Total βhCG (5th IS) Regulation Number: 21 CFR 862.1155 Regulation Name: Human Chorionic Gonadotropin (hCG) Test System Regulatory Class: Class II Product Code: DHA Dated: July 5, 2022 Received: July 6, 2022
Dear Kate Oelberg:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
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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 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Marianela Perez-torres -S
Marianela Perez-Torres, Ph.D. Acting Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K221990
Device Name ACCESS TOTAL BHCG (5th IS)
Indications for Use (Describe)
The Access Total BhCG (5th IS) assay is a paramagnetic particle, chemiluminescent immunoassay for the 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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| × Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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Access Total βhCG (5th IS) 510(k) Summary
510 (k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92(a)(1).
The assigned 510(k) number is K221990.
Submitted By:
Beckman Coulter, Inc. 1000 Lake Hazeltine Drive Chaska, MN 55318
Contact Person:
Kate Oelberg 1000 Lake Hazeltine Drive Chaska, MN 55318 Phone: (612) 431-7315 Email: kmoelberq@beckman.com
Alternate Contact:
Kuljeet Kaur Office Phone: (952) 465-1914 Email: kkaur@beckman.com
Date Prepared:
July 5, 2022
Device Name:
Common Name: Total βhCG (5th IS) Assay Trade Name: Access Total BhCG (5th IS) Classification Name: Human chorionic gonadotropin (HCG) test system Classification Regulation: [21 CFR 862.1155] Product Code: DHA
Predicate Device:
The Access Total βhCG (5th IS) Assay/Calibrators claim substantial equivalence to previously cleared Access Total βhCG (5th IS) Assay FDA 510(k) Number K130020 cleared on 10/1/2013.
Device Description:
The Access Total βhCG (5th IS) assay is a paramagnetic particle, chemiluminescent immunoassay for the 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.
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Intended Use:
The Access Total βhCG (5 th IS) assay is a paramagnetic particle, chemiluminescent immunoassay for the 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.
Comparison of Technological Characteristics to the Predicate (Assay)
| SystemAttribute/Characteristic | Access Total ββhCG (5th IS)on Dxl 9000 AccessImmunoassay AnalyzerK221990 | Predicate Access TotalββhCG (5th IS) on Dxl 800Access ImmunoassaySystem K130020 |
|---|---|---|
| Intended Use/Indications for Use | The Access Total βhCG (5thIS) assay is a paramagneticparticle, chemiluminescentimmunoassay for thequantitative determination ofhuman Total βhCG (5th IS)levels in human serum andplasma. This assay is intendedfor use as an aid in the earlydetection of pregnancy. | Same |
| Analyte Measured | Total βhCG | Same |
| Standardization | WHO 5th InternationalStandard for ChorionicGonadotropin (NIBSC Code07/364) | Same |
| Technology | Two-step sandwich | Same |
| Format | Chemiluminescent | Same |
| Method | Automated | Same |
| Calibration | Utilizes a stored calibrationcurve | Same |
| Sample Type | Serum or lithium heparinplasma | Same |
| Measuring Range | 0.6 to approximately 1350mIU/mL | Same |
| Stability | Stable at 2 to 10°C for 28 daysafter initial use | Same |
| Reagent Packformulation andpackaging | Access Reagent Packformulation and packaging. | Same |
| Instrument | Dxl 9000 AccessImmunoassay Analyzer | UniCel Dxl 800 AccessImmunoassay System |
| Substrate | Lumi-Phos PRO substrate | Access Substrate |
| Reagent Configurations | Two Configurations:1) 100 determinations, 2) | One Configuration:100 determinations, 2 packs, |
| SystemAttribute/Characteristic | Access Total ββhCG (5th IS)on Dxl 9000 AccessImmunoassay AnalyzerK221990 | Predicate Access Total ββhCG (5th IS) on Dxl 800Access ImmunoassaySystem K130020 |
| packs, 50 tests/pack (forpredicate and candidateinstrument)2) 200 determinations, 2packs, 100 tests/pack (forcandidate instrument only) | 50 tests/pack |
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Summary of Studies:
Method Comparison: The results of the within range method comparison study met the acceptance criteria of R2 ≥ 0.90 and slope 1.00 ± 0.10 and supports the equivalence of the Access Total ßhCG assay on Dxl 9000 to the predicate device, the Access Total BhCG assay on Access 2 Instrument. The bias estimate data supports the reference intervals defined on the Access 2 system have not changed appreciably on the Dxl 9000 system.
Imprecison: The within-laboratory (total) % CV ranged from 2.5% to 4.7%, for hCG concentrations > 3.9 mlU/mL. The within-laboratory (total) SD ranged from 0.04 to 0.06 for hCG concentrations ≤ 3.9 mlU/mL ..
Linearity: This study shows that the acceptance criteria was met for non-linearity within ± 0.39 mlU/mL for values ≤ 3.9 mlU/mL and ± 10.0% for values > 3.9 mlU/mL.
Reproducibility: This study shows that the Access Total ßhCG (5th IS) assav meets design input requirements for reproducibility on the Dxl 9000 with an SD ≤ 0.51 for values ≤ 3.9 mlU/mL and CV < 13.0% for values > 3.9 mlU/mL.
LoB/LoD: The data demonstrated the LoB estimate of the Total βhCG (5th IS) assay is 0.1 mlU/mL and the LoD is 0.2 mIU/mL.
LoQ: LoQ was determined as the lowest concentration which met the design requirements of 20% CV and recovery of ± 0.1 mIU/mL for three reagent lots when compared to the WHO 5™ International Standard for Chorionic Gonadotropin (NIBSC Code 07/364). This study determined the LoQ for Access Total βhCG (5th IS) to be 0.6 mIU/mL (IU/L).
Substantial Equivalence Comparison Conclusion
The information provided in this submission supports a substantial equivalence determination, and therefore 510(k) premarket notification clearance of the Total βhCG (5th IS) assay on DxI 9000 Access Immunoassav Analyzer.
§ 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.