(240 days)
The Atellica IM Total hCG (ThCG) assay is for in vitro diagnostic use in the quantitative determination of human chorionic gonadotropin (hCG) in human serum using the Atellica IM Analyzer. The Atellica IM ThCG assay is intended for use as an aid in the early detection of pregnancy.
The Atellica IM Total hCG (ThCG) assay is an in vitro diagnostic assay for the quantitative determination of human chorionic gonadotropin (hCG) in human serum using the Atellica IM Analyzer. The assay utilizes a sandwich immunoassay principle with direct chemiluminescent technology. The reagents include a Lite Reagent containing goat polyclonal anti-hCG antibody labeled with acridinium ester and a Solid Phase containing mouse monoclonal anti-hCG antibody covalently coupled to paramagnetic particles. Ancillary reagents like Atellica IM ThCG DIL are also part of the system.
The Siemens Atellica IM Total hCG (ThCG) assay is an in vitro diagnostic device for the quantitative determination of human chorionic gonadotropin (hCG) in human serum, intended as an aid in the early detection of pregnancy.
Here's an analysis of its acceptance criteria and the study that proves its performance:
1. Table of Acceptance Criteria and Reported Device Performance:
The provided document outlines several performance characteristics, including detection capability, precision, and method comparison, against a predicate device (ADVIA Centaur Total hCG assay).
| Performance Characteristic | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Detection Capability | ||
| Limit of Blank (LoB) | Not explicitly stated as acceptance criteria, but lowest measurement result for a blank sample expected to be below LoD/LoQ. | 1.5 mIU/mL (IU/L) |
| Limit of Detection (LoD) | Probability of 95% detection for the lowest concentration. | 1.7 mIU/mL (IU/L) (determined using 601 determinations, with 300 blank and 301 low-level replicates, and an LoB of 1.5 mIU/mL (IU/L)). |
| Limit of Quantitation (LoQ) | Lowest amount of hCG with a percent total error of 30%. | 2.6 mIU/mL (IU/L) (determined using multiple samples prepared from WHO reference material (NIBSC code: 99/688) in the interval 1.9–6.7 mIU/mL (IU/L). All samples were assayed in replicates of 5 in each of 2 runs per day using 2 reagent lots, over a period of 5 days). |
| Precision | Not explicitly stated as numerical acceptance criteria, but typical expectations are low %CV for various levels. | Repeatability (Within-run): Serum 1 (2.4 mIU/mL): 8.8% CV; Serum 2 (12.6 mIU/mL): 2.8% CV; Serum 3 (782.0 mIU/mL): 1.8% CV. Control 1 (6.8 mIU/mL): 4.5% CV; Control 2 (23.4 mIU/mL): 2.6% CV; Control 3 (202.1 mIU/mL): 1.8% CV. Within-Lab: Serum 1 (2.4 mIU/mL): 10.5% CV; Serum 2 (12.6 mIU/mL): 3.4% CV; Serum 3 (782.0 mIU/mL): 2.2% CV. Control 1 (6.8 mIU/mL): 5.5% CV; Control 2 (23.4 mIU/mL): 3.5% CV; Control 3 (202.1 mIU/mL): 2.7% CV. |
| Method Comparison | Correlation coefficient (r) ≥ 0.95 and a slope of 1.0 ± 0.10 compared to the ADVIA Centaur Total hCG assay. | r = 1.00 (for serum samples, n=115, in the range 2.4-947.7 mIU/mL (IU/L)). Regression Equation: $y = 0.94x + 0.23 mIU/mL (IU/L)$. The slope (0.94) is within the 1.0 ± 0.10 criterion. The intercept (0.23) indicates a small constant bias. |
| Interference | Not explicitly stated as acceptance criteria, but generally a bias of ≤ 10% is considered acceptable for common interfering substances. | Most reported bias values for various substances (Acetaminophen, Acetylsalicylic acid, Atropine, Caffeine, EDTA, Ethanol, Gentisic acid, Heparin, Human Serum Albumin, Ibuprofen) are well within the typical ±10% range. For HIL (Hemoglobin, Bilirubin, Lipemia), the assay is designed to have ≤ 10% interference, and reported values are generally within this range (highest reported is 8.9% for Hemoglobin at 5.6 mIU/mL). |
2. Sample Size Used for the Test Set and Data Provenance:
- Detection Capability (LoD): 601 determinations, with 300 blank and 301 low-level replicates. The document doesn't specify data provenance (country of origin or retrospective/prospective).
- Detection Capability (LoQ): Multiple samples prepared from the World Health Organization (WHO) human chorionic gonadotropin reference material (NIBSC code: 99/688). No specific sample count is given for the test set, but it implies a study on prepared samples. Data provenance is implied to be laboratory-based and controlled using a recognized international standard.
- Precision: Not a "test set" from patients, but rather control materials and serum pools. Samples were assayed in duplicate in 2 runs per day for 20 days using two reagent lots on each of two Atellica IM analyzers, leading to
320data points for each serum pool and control (2 duplicates * 2 runs/day * 20 days * 2 analyzers * 1 sample type / 2 for reagent lots = 320 for each condition) - Method Comparison: 115 serum specimens. The data provenance (country of origin, retrospective or prospective) is not specified.
- Interference: "Serum samples" used, concentrations given, but no specific number of unique patient samples mentioned.
- Expected Values: 366 serum samples from 192 apparently healthy non-pregnant females and 174 apparently healthy postmenopausal females. The provenance is not specified. This appears to be a prospective collection for establishing reference ranges.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not applicable as the Atellica IM Total hCG assay is a quantitative diagnostic test for a biomarker (hCG) in serum. The 'ground truth' for such assays is typically established by:
- Reference Methods: Highly accurate and precise laboratory methods.
- Certified Reference Materials: Materials with an assigned value from an authoritative source (like the WHO reference material mentioned for LoQ).
- Clinical Diagnosis: For outcomes like pregnancy, a clinical diagnosis confirms the state, and the device then quantifies the biomarker associated with that state.
There is no mention of human experts establishing a 'ground truth' in the context of image interpretation or subjective diagnosis for this device.
4. Adjudication Method for the Test Set:
This is not applicable as the Atellica IM Total hCG assay is an automated quantitative assay. There is no subjective interpretation or need for adjudication by experts as would be found in image-based diagnostic systems.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance:
This is not applicable. The Atellica IM Total hCG assay is an automated in vitro diagnostic device, not an AI-assisted diagnostic tool that involves human readers interpreting cases. Therefore, an MRMC study related to human reader improvement with AI assistance is not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
The performance studies described (detection capability, precision, method comparison, interference, expected values) represent the standalone performance of the Atellica IM Total hCG assay. This device is designed to provide quantitative results directly from serum samples through an automated analyzer, without direct human-in-the-loop interpretation that would alter the result. The device performance itself is evaluated.
7. The Type of Ground Truth Used:
- Detection Capability (LoD, LoQ): Determined using prepared samples traceable to the World Health Organization (WHO) 4th International Standard (NIBSC code: 99/688) for human chorionic gonadotropin. This is a form of certified reference material ground truth.
- Precision: Internal serum pools and commercial controls with known concentrations served as the basis for evaluating reproducibility.
- Method Comparison: The ADVIA Centaur Total hCG assay (predicate device) served as the comparative reference, implying that its established measurements were the 'ground truth' for comparison, to show substantial equivalence.
- Interference: Spiked serum samples (serum with known amounts of hCG and interferents added) were used.
- Expected Values: Clinical classification of "non-pregnant females" and "postmenopausal females" served as the basis for establishing reference intervals. This aligns with clinical outcome/classification ground truth.
8. The Sample Size for the Training Set:
The document does not explicitly describe a "training set" in the context of machine learning or AI, as this is an immunoassay device. The studies described are performance validation studies. The calibration of the device (using Atellica IM CAL B) and the determination of its "master curve" can be thought of as akin to a training process for an assay, but no sample size for this is provided.
9. How the Ground Truth for the Training Set Was Established:
As mentioned, there isn't a "training set" in the AI/ML sense. The "ground truth" for the assay's operational parameters (like calibration and standardization) is established through:
- Standardization against the World Health Organization (WHO) 4th IS 75/589 reference material. This is a universally recognized standard, meaning calibrator values are traceable to this international reference.
- Two-point calibration using specific calibrators (Atellica IM CAL B) which themselves are assigned values traceable to the WHO standard.
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Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 29, 2018
Siemens Healthcare Diagnostics Inc. Anoop Joy Regulatory Clinical Affairs Specialist 511 Benedict Avenue Tarrytown, NY 10591
Re: K172322
Trade/Device Name: Atellica IM Total hCG (ThCG) Regulation Number: 21 CFR 862.1155 Regulation Name: Human chorionic gonadotropin (HCG) test system Regulatory Class: Class II Product Code: JHI Dated: February 20, 2018 Received: February 21, 2018
Dear Anoop Joy:
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 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR
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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.
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.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely, Kellie B. Kelm -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
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| DEPARTMENT OF HEALTH AND HUMAN SERVICES | |
|---|---|
| Food and Drug Administration | |
| Indications for Use | |
| Form Approved: OMB No. 0910-0120 | |
| Expiration Date: January 31, 2017 | |
| See PRA Statement below. |
| 510(k) Number (if known) | K172322 |
|---|---|
| Device Name | Atellica IM Total hCG (ThCG) |
| Indications for Use (Describe) | The Atellica IM Total hCG (ThCG) assay is for in vitro diagnostic use in the quantitative determination of human chorionic gonadotropin (hCG) in human serum using the Atellica IM Analyzer. The Atellica IM ThCG 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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510(k) Summary of Safety and Effectiveness
Atellica IM Total hCG (ThCG)
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) Number: K172322
. APPLICANT
Siemens Healthcare Diagnostics Inc. 511 Benedict Avenue, Tarrytown, NY 10591 USA
| Contact: | Anoop Joy |
|---|---|
| Regulatory Clinical Affairs Specialist | |
| Phone: | (914) 524-2273 |
| Fax: | (914) 524-3579 |
| E-mail: | anoop.joy@siemens-healthineers.com |
Date Prepared: March 28, 2018
Regulatory Information II.
Assay
Name of Device: Atellica IM Total hCG (ThCG) Classification: Class II Regulation Section: 21 CFR § 862.1155 Product Code: JHI Panel: Clinical Chemistry
PREDICATE DEVICE .
Assay
Name of Device: ADVIA Centaur® Total hCG assay 510 (k): K925277
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The Atellica IM ThCG Assay reagents come in the following configurations:
| Contents | Numberof Tests |
|---|---|
| 1 ReadyPack primary reagent pack containing Atellica IM ThCGLite Reagent and Solid PhaseAtellica IM ThCG master curve and test definition | 90 |
| 5 ReadyPack primary reagent packs containing Atellica IM ThCGLite Reagent and Solid PhaseAtellica IM ThCG master curve and test definition | 450 |
The ReadyPack consists of the following:
Atellica IM ThCG ReadyPack® primary reagent pack Lite Reagent
5.0 ml/reagent pack Goat polyclonal anti-hCG antibody (~0.1 µg/mL) labeled with acridinium ester in buffered saline; sodium azide (0.1%); preservatives
Solid Phase
22.5 mL/reagent pack Mouse monoclonal anti-hCG antibody (~0.02 mg/mL) covalently coupled to paramagnetic particles in buffered saline; sodium azide (0.1%); preservatives.
Atellica IM ThCG DIL ReadyPack ancillary reagent pack
25.0 mL/pack Buffered heat-treated equine serum; EDTA; sodium azide (< 0.1%); preservatives
Atellica IM ThCG DIL
50.0 mL/vial Buffered heat-treated equine serum; EDTA; sodium azide (< 0.1%); preservatives
INDICATIONS FOR USE >
The Atellica IM Total ß-hCG (ThCG) assay is for in vitro diagnostic use in the quantitative determination of human gonadotropin (hCG) in human serum using the Atellica IM Analyzer.
The Atellica IM ThCG assay is intended for use as an aid in the early detection of pregnancy.
INTENDED USE VI.
Same as Indications for Use
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COMPARISION OF TECHNOLOGICAL CHARACTERISTICS WITH THE VII PREDICATE DEVICE
The following table provides a comparison between the predicate and candidate device.
| Assay | ||
|---|---|---|
| Item | Predicate Device | Candidate Device |
| Intended Use | For in vitro diagnostic use in thequantitative determination ofhuman chorionic gonadotropin(hCG) in serum. The resultsobtained from hCG specimens areused as an aid in the assessmentof pregnancy status. This assaydetects the intact hCG moleculeand free beta-subunits of the hCGmolecule. | The Atellica IM Total β-hCG(ThCG) assay is for in vitrodiagnostic use in the quantitativedetermination of humangonadotropin (hCG) in humanserum using the Atellica IMAnalyzer.The Atellica IM ThCG assay isintended for use as an aid in theearly detection of pregnancy. |
| Measurement | Quantitative | Same |
| Assay Range | 2.0–1000 mIU/mL (IU/L) | 2.6–1000 mIU/mL (IU/L) |
| Assay Principle | Sandwich immunoassay | Same |
| Technology | Direct chemiluminescent | Same |
| Sample Type | Serum | Same |
| Sample Volume | 50 µL | 25 µL |
| ReagentVolume | 100 µL of Lite Reagent and 450 µLof Solid Phase | 50 µL of Lite Reagent and 225 µLof Solid Phase |
| IncubationTime | 7.5 minutes at 37°C. | 8 minutes at 37°C |
| Standardization | Standardized against the WorldHealth Organization (WHO) 4th IS75/589 reference material.Assigned values for calibrators aretraceable to thisstandardization. | Same |
| Calibration | 2-point | Same |
| Calibrators | ADVIA Centaur Calibrator B | Atellica IM CAL B |
| Number ofCalibratorLevels | Two levels | Same |
| Controls | Commercial Controls | Same |
| Number ofControl Levels | 2 | Same |
| DetectionAntibody | Goat polyclonal anti-hCG antibodylabeled with acridinium ester | Same |
| CaptureAntibody | Mouse monoclonal anti-hCGantibodycovalently coupled to paramagnetic | Same |
| particles | ||
| ExpectedValues | 2–4 weeks 39.1–8388 (mIU/mL)(IU/L)5–6 weeks 861–88,7696–8 weeks 8636–218,0858–10 weeks 18,700–244,46710–12 weeks 23,143–181,89913–27 weeks 6303–97,17128–40 weeks 4360–74,883 | The 2.5 and 97.5 percentiles of theconcentration values wereconsidered the expected valuerange of the Atellica IM ThCGassay. The expected value range ofnon-pregnant females was 1.5—4.2mIU/mL (IU/L) and thepostmenopausal female populationwas 1.8–10.1 mIU/mL (IU/L) |
Table 1: Substantial Equivalence Comparison
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PERFORMANCE CHARACTERISTICS DATA VIII.
Detection Capability
Detection capability was determined in accordance with CLSI Document EP17-A2.
The LoB corresponds to the highest measurement result that is likely to be observed for a blank sample. The LoB of the Atellica IM ThCG assay is 1.5 mIU/mL (IU/L).
The LoD corresponds to the lowest concentration of hCG that can be detected with a probability of 95%. The LoD for the Atellica IM ThCG assay is 1.7 mlU/mL (IU/L), and was determined using 601 determinations, with 300 blank and 301 low-level replicates, and an LoB of 1.5 mIU/mL (IU/L).
The LoQ corresponds to the lowest amount of hCG in a sample at which the percent total error is 30%. The LoQ of the Atellica IM ThCG assay is 2.6 mIU/mL (IU/L), and was determined using multiple samples prepared from the World Health Organization (WHO) human chorionic gonadotropin reference material (NIBSC code: 99/688) in the interval 1.9–6.7 mIU/mL (IU/L). All samples were assayed in replicates of 5 in each of 2 runs per day using 2 reagent lots, over a period of 5 days
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Precision
Precision was determined in accordance with CLSI Document EP05-A3. Samples were assayed in duplicate in 2 runs per day for 20 days using two reagent lots on each of two Atellica IM analyzers. The following results were obtained:
| Sample | Na | MeanmIU/mL(IU/L) | Repeatability | Between Run | Between Day | Within-Lab | ||||
|---|---|---|---|---|---|---|---|---|---|---|
| SDbmIU/mL(IU/L) | %CVc | SDmIU/mL(IU/L) | %CVc | SDbmIU/mL(IU/L) | %CVc | SDbmIU/mL(IU/L) | %CVc | |||
| Serum 1 | 320 | 2.4 | 0.2 | 8.8 | 0.1 | 3.3 | 0.1 | 4.7 | 0.3 | 10.5 |
| Serum 2 | 320 | 12.6 | 0.4 | 2.8 | 0.2 | 1.6 | 0.1 | 1.0 | 0.4 | 3.4 |
| Serum 3 | 320 | 782.0 | 14.0 | 1.8 | 6.9 | 0.9 | 6.7 | 0.9 | 17.0 | 2.2 |
| Control 1 | 320 | 6.8 | 0.3 | 4.5 | 0.0 | 0.3 | 0.2 | 3.0 | 0.4 | 5.5 |
| Control 2 | 320 | 23.4 | 0.6 | 2.6 | 0.4 | 1.7 | 0.4 | 1.6 | 0.8 | 3.5 |
| Control 3 | 320 | 202.1 | 3.6 | 1.8 | 2.4 | 1.2 | 3.4 | 1.7 | 5.5 | 2.7 |
Number of samples tested. a
മ Standard deviation.
- Coefficient of variation. ು
Method Comparison
The Atellica IM ThCG assay is designed to have a correlation coefficient of ≥ 0.95 and a slope of 1.0 ±0.10 compared to the ADVIA Centaur Total hCG assay. Assay comparison was determined using the weighted Deming regression model in accordance with CLSI Document EP09-A3. The following results were obtained:
| Specimen | Comparative Assay (x) | Regression Equation | Sample Interval | Nᵃ | rᵇ |
|---|---|---|---|---|---|
| Serum | ADVIA Centaur Total hCG | $y = 0.94x + 0.23 mIU/mL (IU/L)$ | 2.4-947.7 mIU/mL (IU/L) | 115 | 1.00 |
a Number of samples tested.
b Correlation coefficient.
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Interference testing was performed in accordance with CLSI Document EP07-A2 using the Atellica IM Analyzer.
The following substances were added to serum samples containing different concentrations of hCG. Bias is the difference in the results between the control sample (does not contain the interferent) and the test sample (contains the interferent) expressed in percent. Analyte results should not be corrected based on the bias.
| Substance | Substance Test Concentration | Analyte ConcentrationmIU/mL (IU/L) | Bias (%) |
|---|---|---|---|
| Acetaminophen | 20 mg/dL | 5.7 | 0.9 |
| 20 mg/dL | 495.3 | 2.9 | |
| Acetylsalicylic acid | 65 mg/dL | 5.4 | 7.3 |
| 65 mg/dL | 502.1 | -0.8 | |
| Atropine | 20 mg/dL | 5.7 | -4.7 |
| 20 mg/dL | 503.6 | -0.9 | |
| Caffeine | 308 $ µmol/L $ | 5.6 | 5.4 |
| 308 $ µmol/L $ | 511.9 | -1.8 | |
| EDTA | 3.4 $ µmol/L $ | 5.5 | 5.9 |
| 3.4 $ µmol/L $ | 508.9 | -2.2 | |
| Ethanol | 100 mg/dL | 6.0 | -6.6 |
| 100 mg/dL | 506.2 | 2.0 | |
| Gentisic acid | 117 $ µmol/L $ | 6.2 | -5.8 |
| 117 $ µmol/L $ | 507.1 | -2.7 | |
| Heparin | 7200 IU/dL | 5.5 | -2.3 |
| 7200 IU/dL | 491.3 | 1.1 | |
| Human Serum Albumin | 6 g/dL | 6.0 | -0.3 |
| 6 g/dL | 511.8 | 1.3 | |
| Ibuprofen | 50 mg/dL | 5.5 | 6.5 |
| 50 mg/dL | 490.1 | -2.7 |
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Hemolysis, Icterus, and Lipemia (HIL): The Atellica IM ThCG assay is designed to have ≤ 10% interference from hemoglobin, bilirubin, and lipemia. Interfering substances were tested at the levels indicated in the table below. Bias is the difference in the results between the control sample (does not contain the interferent) and the test sample (contains the interferent) expressed in percent.
| Substance | Substance Test Concentration | Analyte ConcentrationmIU/mL (IU/L) | Bias (%) |
|---|---|---|---|
| Hemoglobin | 1000 mg/dL (0.62 mmol/L) | 5.6 | 8.9 |
| 1000 mg/dL (0.62 mmol/L) | 501.7 | -1.2 | |
| Bilirubin, conjugated | 40 mg/dL (681 $\mu$ mol/L) | 6.1 | -0.3 |
| 40 mg/dL (681 $\mu$ mol/L) | 530.3 | -1.8 | |
| Bilirubin, unconjugated | 40 mg/dL (681 $\mu$ mol/L) | 6.0 | 0.3 |
| 40 mg/dL (681 $\mu$ mol/L) | 520.8 | -1.8 | |
| Lipemia (Intralipid®) | 3000 mg/dL (34 mmol/L) | 6.1 | 2.0 |
| 3000 mg/dL (34 mmol/L) | 458.8 | 2.4 |
Expected Values
Data were obtained on 366 serum samples from 192 apparently healthy non-pregnant females and 174 apparently healthy postmenopausal females. The expected value range of non-pregnant females was 1.5—4.2 mIU/mL (IU/L) and the postmenopausal female population was 1.8–10.1 mIU/mL (IU/L), as shown in the table below.
| Sample Category | Na | MedianmIU/mL (IU/L) | Reference IntervalmIU/mL (IU/L)2.5-97.5 Percentile |
|---|---|---|---|
| Non-Pregnant Females(Age: 17-54) | 192 | 2.0 | 1.5-4.2 |
| Postmenopausal FemalesAge: ≥ 41 | 174 | 3.9 | 1.8-10.1 |
a Number of samples.
CONCLUSION x
Comparative testing of the Atellica IM ThCG Assay is substantially equivalent in principle and performance to the Predicate Device - ADVIA Centaur® Total hCG assay cleared under 510(k) K925277.
§ 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.