(144 days)
The DiaSorin LIAISON® XL HCG assay uses chemiluminescent immunoassay (CLIA) technology on the LIAISON® XL Analyzer for the quantitative determination of total human chorionic gonadotropin (hCG and ßhCG) in human serum for early detection of pregnancy. Total hCG is the measurement of intact and beta-hCG.
The method for the quantitative determination of hCG is a sandwich chemiluminescence immunoassay. A specific mouse monoclonal antibody is coated on the magnetic particles (solid phase); another monoclonal antibody is linked to an isoluminol derivative (isoluminol-antibody conjugate). All assay steps and incubations are performed by the LIAISON® XL Analyzer.
During the first incubation, hCG present in calibrators, samples or controls binds to the solid phase monoclonal antibody, and subsequently after a washing step in a second incubation the antibody conjugate reacts with hCG already bound to the solid phase.
Subsequently, the starter reagents are added and a flash chemiluminescence reaction is thus induced. The light signal, and hence the amount of isoluminol-antibody conjugate, is measured by a photomultiplier as relative light units (RLU, relative light units) and is directly related to hCG concentration present in calibrators, samples or controls.
Here's an analysis of the DiaSorin LIAISON® XL HCG Premarket Notification (K131037) based on the provided text, focusing on acceptance criteria and study details:
Acceptance Criteria and Device Performance for DiaSorin LIAISON® XL HCG
The DiaSorin LIAISON® XL HCG assay is a chemiluminescent immunoassay (CLIA) for the quantitative determination of total human chorionic gonadotropin (hCG and βhCG) in human serum for early detection of pregnancy. The submission aims to demonstrate substantial equivalence to the Roche ELECSYS® HCG +Beta Test (K003178).
The document details several performance studies to support the device's claims.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state "acceptance criteria" as pass/fail thresholds for each performance characteristic. Instead, it reports the results of the performance studies which implicitly serve as the basis for demonstrating substantial equivalence. For the purpose of this analysis, I will infer the intended acceptance of "good performance" based on the reported values and comparison to the predicate where applicable.
| Performance Characteristic | Implicit Acceptance Criteria (or Reference) | Reported Device Performance (DiaSorin LIAISON® XL HCG) |
|---|---|---|
| Method Comparison | Good correlation with predicate device | y = 0.973x - 0.2233; R² = 0.9933 (vs. predicate) |
| Reference Range | Clearly defined ranges for non-pregnant populations | - Premenopausal (<50): 97.5% < 1.54 mIU/mL hCG - Postmenopausal (≥50): 97.5% < 6.67 mIU/mL hCG |
| Reproducibility/Precision | Low %CV for within-run and total precision across different hCG levels | - QC1 (6.4 mIU/mL): Total %CV 10.7% - QC2 (23.3 mIU/mL): Total %CV 6.0% - QC3 (175.1 mIU/mL): Total %CV 3.5% - HCG-11 (60.2 mIU/mL): Total %CV 4.9% - HCG-12 (25.5 mIU/mL): Total %CV 6.3% - HCG-13 (431.4 mIU/mL): Total %CV 3.0% - HCG-14 (893.2 mIU/mL): Total %CV 3.2% - HCG-15 (4169.0 mIU/mL): Total %CV 3.7% - HCG-16 (9607.6 mIU/mL): Total %CV 3.2% |
| Dilution Linearity | Good linear regression between obtained and expected concentrations | Y (obtained mIU/mL) = 1.0158X (expected mIU/mL) - 0.1450 |
| LoB (Limit of Blank) | Low value | 0.17 mIU/L |
| LoD (Limit of Detection) | Low value | 0.36 mIU/L |
| LoQ (Limit of Quantitation) | Low value | 1.5 mIU/L |
| Recovery | % recovery near 100% across spiked levels | - 5 mIU/mL: 91.8% - 25 mIU/mL: 105.9% - 500 mIU/mL: 94.9% - 5000 mIU/mL: 92.9% - 9000 mIU/mL: 96.9% |
| Interfering Substances | No significant interference at specified concentrations | No interference reported at tested concentrations for various substances (Triglycerides, Hemoglobin, Bilirubin, Albumin, RF, LH, FSH, hGH, TSH, common medications) |
2. Sample Size Used for the Test Set and Data Provenance
- Method Comparison: One hundred sixty-three (163) serum samples. The data provenance is not explicitly stated (e.g., country of origin) but is implied to be clinical samples spanning the assay's reportable range. The study was performed according to CLSI EP9-A2 guideline. It is a retrospective analysis using collected samples.
- Reference Range/Expected Values:
- 74 healthy, non-pregnant premenopausal women (<50 years old).
- 70 healthy, postmenopausal women (≥ 50 years old).
- The study was performed according to CLSI Approved Guideline C28-A3. Data provenance is not explicitly stated.
- Reproducibility/Precision: A coded panel comprised of 6 frozen serum samples (low, medium, high levels) and 3 commercial controls. Each sample/control was tested 160 times (N=160 in the table). This study was performed at DiaSorin Inc., implying internal, controlled data. The CLSI document EP05-A2 was consulted.
- Dilution Linearity: Two serum pools containing high hCG concentrations. Details on individual sample numbers beyond "two serum pools" are not provided. The study followed CLSI EP6-A.
- LoB/LoD/LoQ: The methodology followed CLSI EP17-A2, which typically involves multiple replicates of blank and low-concentration samples. Specific sample sizes are not explicitly stated for individual calculations but are implied by the CLSI standard.
- Recovery: Five levels of spiked samples (prepared from five human sera), tested in duplicates.
- Interfering Substances: Controlled studies at two hCG levels for each interfering substance, implying multiple tests per substance. The testing was based on CLSI-EP7-A2.
The data appears to be primarily from internal studies (e.g., DiaSorin Inc. for reproducibility) or clinical samples whose specific origin (e.g., country) is not disclosed but collected according to CLSI guidelines, indicating a general clinical relevance. All studies appear to be retrospective analyses of collected samples or controlled laboratory experiments.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
For this type of in-vitro diagnostic device (an immunoassay for HCG), the "ground truth" for the test set is established by the actual concentration of hCG in the samples, measured through established reference methods or spiking procedures. This is typically determined by laboratory equipment calibration against recognized standards (e.g., WHO reference standard IS 75/537, as noted for traceability). It does not involve human experts (like radiologists) interpreting images or clinical cases to establish ground truth.
4. Adjudication Method for the Test Set
Adjudication methods (like 2+1, 3+1) are common in studies involving human interpretation of data (e.g., image-based diagnosis). Since this is an immunoassay for quantitative measurement of a biomarker, "adjudication" in that sense is not applicable. The accuracy of measurements is assessed against established reference materials or methods, and potential discrepancies would be investigated through re-testing, calibration checks, or review of laboratory protocols.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. MRMC studies are typically performed for diagnostic imaging devices where different human readers interpret cases with and without AI assistance. This submission pertains to an automated in-vitro diagnostic assay for a biochemical marker, which does not involve human readers interpreting "cases" in the same way.
6. Standalone (Algorithm Only) Performance
Yes, the performance data presented (Method Comparison, Reference Range, Reproducibility, Dilution Linearity, LoB/LoD/LoQ, Recovery, Interfering Substances) is the standalone performance of the DiaSorin LIAISON® XL HCG assay. As an automated immunoassay, it operates without direct human intervention in the measurement process once the sample is loaded and the assay initiated. The results are generated directly by the LIAISON® XL Analyzer.
7. The Type of Ground Truth Used
The ground truth used for the performance studies is primarily:
- Reference Intervals: Established by testing samples from well-defined healthy populations (premenopausal, postmenopausal women) whose non-pregnant status is the established biological ground truth.
- Known Concentrations: For method comparison, linearity, LoB/LoD/LoQ, and recovery, the ground truth is often established through:
- Predicate Device Measurements: In method comparison, the predicate device results (Roche Elecsys® HCG +Beta Test) serve as a comparative ground truth.
- Spiked Samples: For recovery and linearity studies, samples are "spiked" with known concentrations of hCG (traceable to WHO reference standard IS 75/537), providing a known expected value.
- Reference Materials: Calibration and accuracy are traceable to the 3rd WHO reference standard IS 75/537, which is the ultimate gold standard for hCG concentration.
- CLSI Guidelines: Adherence to CLSI guidelines ensures standardized and accepted methods for determining these performance characteristics.
8. The Sample Size for the Training Set
The document does not specify a "training set" size. This is because the DiaSorin LIAISON® XL HCG assay is a traditional immunoassay, not an AI/machine learning model that requires a distinct training phase on a dataset of images or complex inputs to learn patterns. The "training" in this context refers to the development and optimization of the assay reagents, protocols, and instrument parameters by DiaSorin scientists, not the algorithmic training of an AI system.
9. How the Ground Truth for the Training Set Was Established
As noted above, there is no "training set" in the context of an AI/machine learning system. For the development and optimization of the immunoassay, the "ground truth" would have been established through a rigorous process of:
- Analytical Chemistry and Biology: Ensuring antibody specificity, optimal reaction conditions, signal detection, and calibration against internationally recognized standards (like the WHO hCG reference standard).
- Internal Development and Verification: DiaSorin's R&D team would have used a wide range of precisely characterized HCG samples (known concentrations, spiked samples, clinical samples) to develop and refine the assay. The ultimate "ground truth" during this phase would be the known concentration of HCG in these samples, traceable to the WHO standard.
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DiaSorin LIAISON® XL HCG Premarket Notification
5.0 510(k) SUMMARY
SUBMITTED BY:
Mari Mever Director, Regulatory Affairs DiaSorin Inc. 1951 Northwestern Avenue P.O. Box 285 Stillwater, MN 55082-0285 Phone (651) 439-9710 Fax (651) 351-5669 Email: mari.meyer@diasorin.com
SEP
06
2013
NAME OF DEVICE:
Trade Name:
Common Names/Descriptions:
Classification Names:
LIAISON® XL HCG
Human Chorionic Gonadotropin (hCG)
Human Chorionic Gonadotropin (hCG) test system
Product Code:
DHA
PREDICATE DEVICE:
Roche ELECSYS® HCG +Beta Test Reference K003178
DEVICE DESCRIPTION:
INTENDED USE:
The DiaSorin LIAISON® XL HCG assay uses chemiluminescent immunoassay (CLIA) technology on the LIAISON® XL Analyzer for the quantitative determination of total human chorionic gonadotropin (hCG and ßhCG) in human serum for early detection of pregnancy. Total hCG is the measurement of intact and beta-hCG.
KIT DESCRIPTION:
The method for the quantitative determination of hCG is a sandwich chemiluminescence immunoassay. A specific mouse monoclonal antibody is coated on the magnetic particles (solid phase); another monoclonal antibody is linked to an isoluminol derivative (isoluminol-antibody conjugate). All assay steps and incubations are performed by the LIAISON® XL Analyzer.
During the first incubation, hCG present in calibrators, samples or controls binds to the solid phase monoclonal antibody, and subsequently after a washing step in a second incubation the antibody conjugate reacts with hCG already bound to the solid phase.
Subsequently, the starter reagents are added and a flash chemiluminescence reaction is thus induced. The light signal, and hence the amount of isoluminol-antibody
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conjugate, is measured by a photomultiplier as relative light units (RLU, relative light units) and is directly related to hCG concentration present in calibrators, samples or controls.
COMPARISON TO PREDICATE DEVICE:
The DiaSorin LIAISON XL HCG assay is substantially equivalent in principle and performance to the Roche Elecsys® HCG +Beta Test (K003178) which was FDA cleared December 14, 2002.
| Table 1: Table of Similarities | ||
|---|---|---|
| Characteristic | New DeviceLIAISON® XL HCG | Predicate DeviceRoche ELECSYS® HCG + BetaTest System (K003178) |
| Intended Use | In-vitro assay for the quantitativedetermination of total humanchorionic gonadotropin (hCG andβhCG) in human serum for earlydetection of pregnancy using theLIAISON® XL Analyzer. | Immunoassay for the in-vitroquantitative determination of the sumof human chorionic gonadotropin(hCG) plus the hCG Beta subunit inhuman serum and plasma. |
| Indications forUse | For the early detection ofpregnancy. | For the early detection of pregnancy. |
| MeasuredAnalyte | human chorionic gonadotropin(hCG) plus the hCG Beta subunit | human chorionic gonadotropin (hCG)plus the hCG Beta subunit |
| Assay Type | Chemiluminescent Immunoassay | ElectrochemiluminescentImmunoassay |
| Test principle | Sandwich chemiluminescentImmunoassay | Sandwich chemiluminescentImmunoassay |
| Solid Support | Paramagnetic particles coated withrecombinant hCG | Paramagnetic particles coated withstreptavidin and coupled tobiotinylated monoclonal hCG-specificantibodies |
| Reagent IntegralStorage | On-board or in refrigerator@ 2-8°C | On-board or in refrigerator@ 2-8°C |
| SampleHandling/Processing | Automated | Automated |
| Unit of Measure | mlU/mL | mlU/mL |
| Traceability | 3rd WHO reference standard IS75/537. | 3rd WHO reference standard IS75/537. |
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| Table 2 : Table of Differences | ||
|---|---|---|
| Characteristic | New DeviceLIAISON® HCG | Predicate DeviceRoche ELECSYS® HCG + BetaTest System (K003178) |
| Instrument | LIAISON® XL Analyzer | Roche Elecsys® Immunoassayanalyzer |
| Calibration | Two-point calibrator verification ofstored master curve.Included with the kit. | Two-point calibrator verification ofstored master curve. Not includedwith the kit. |
| Measuring range | 1.5 - 10,000 mIU/mL | 0.100 - 10,000 mIU/mL |
| Sample Matrix | Human serum | Human serum and plasma |
| Sample size | 30 μL | 10 μL |
| ConjugateAntibody | Anti-hCG antibodies (mouse)labeled with isoluminol | Biotinylated monoclonal anti-hCGantibodies (mouse) |
| Open storage2-8°C | 4 weeks | 12 weeks |
| Controls | No Controls Provided | 2 Levels |
PERFORMANCE DATA:
Method Comparison:
One hundred sixty-three (163) serum samples, that spanned the reportable range of the assay, were tested and analyzed by Weighted Deming Regression. The method comparison study was performed according to CLSI EP9-A2 guideline.
Results:
Weighted Deming Regression analysis was performed on the results across the range of LIAISON® XL HCG assay yielding agreement of y= 0.973x _0.2233; R2 = 0.9933.
Reference Range/Expected Values:
The reference range study was performed according to CLSI Approved Guideline C28-A3. Human serum samples from apparently healthy non-pregnant premenopausal and postmenopausal subjects were tested to determine the reference range for the LIAISON® XL HCG assay. The results are listed below:
· In a study performed on 74 healthy, non-pregnant premenopausal women (<50 years old), 97.5% of the values obtained were below 1.54 mIU/mL hCG.
· In a study performed on 70 healthy, postmenopausal women (≥ 50 years old). 97.5% of the values obtained were below 6.67 mlU/mL hCG.
Consider these limits as guidelines only. It is important for each laboratory to establish its own reference range, representative of its typical population.
Reproducibility/Precision:
A twenty day reproducibility/precision study was performed at DiaSorin Inc. A coded panel comprised of 6 frozen serum samples was prepared by DiaSorin Inc. The coded panel contained levels of low, medium and high samples. Commercial controls (3
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levels) were also tested in the study. The CLSI document EP05-A2 was consulted in the preparation of the testing protocol.
Results
The twenty day results are summarized in the following table as sample overall mean HCG concentration in mIU/mL, computed SDs and %CVs for within run and total across lots.
| PanelID# | N | meanmlU/mL | Between LotSD | Between Lot%CV | TotalSD | Total%CV |
|---|---|---|---|---|---|---|
| QC1 | 160 | 6.4 | 0.02 | 0.3% | 0.68 | 10.7% |
| QC2 | 160 | 23.3 | 0.07 | 0.3% | 1.41 | 6.0% |
| QC3 | 160 | 175.1 | 2.31 | 1.3% | 6.04 | 3.5% |
| HCG-11 | 160 | 60.2 | 0.01 | 0.0% | 2.95 | 4.9% |
| HCG-12 | 160 | 25.5 | 0.31 | 1.2% | 1.60 | 6.3% |
| HCG-13 | 160 | 431.4 | 6.44 | 1.5% | 13.03 | 3.0% |
| HCG-14 | 160 | 893.2 | 15.85 | 1.8% | 28.97 | 3.2% |
| HCG-15 | 160 | 4169.0 | 72.01 | 1.7% | 153.66 | 3.7% |
| HCG-16 | 160 | 9607.6 | 29.89 | 0.3% | 298.61 | 3.2% |
Dilution Linearity:
Two serum pools containing high hCG concentrations were tested neat and after serially diluting following CLSI EP6-A.
The results were analyzed by a Weighted Deming fit of observed hCG concentration versus expected hCG concentration.
Both sample sets yielded similar linear regressions. An example is shown below:Y(obtained mIU/mL) = 1.0158X(expected mIUmL) - 0.1450
LoB/LoD/LoQ:
The Limit of Blank, Limit of Detection and Limit of Quantitation were determined according to CLSI EP17-A2: Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures: Approved Guideline June 2012- Second Edition.
Results:
Limit of Blank: 0.17 mIU/L Limit of Detection: 0.36 mIU/L Limit of Quantitation: 1.5 mIU/L
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DiaSorin LIAISON® XL HCG Premarket Notification
Recovery
A recovery study using five levels of spiked samples, which were prepared by adding the targeting amount of WHO 30 reference standard into five human sera and tested in duplicates using one lot of reagents on one instrument, was conducted. The overall % recovery for each spiked level was determined and are tabulated below.
| Spiked level (mIU/mL) | Overall %recovery |
|---|---|
| 5 | 91.8 |
| 25 | 105.9 |
| 500 | 94.9 |
| 5000 | 92.9 |
| 9000 | 96.9 |
Interfering Substances:
Controlled studies of potentially interfering substances at two hCG levels showed no interference at the concentration for each substance listed below in the LIAISON® XL HCG assay. The testing was based on CLSI-EP7-A2.
| Substance | Highest Concentration Tested |
|---|---|
| Triglycerides | 3000 mg/dL |
| Hemoglobin | 1000 mg/dL |
| Unconjugated bilirubin | 20 mg/dL |
| Conjugated bilirubin | 20 mg/dL |
| Albumin | 6 g/dL |
| Rheumatoid Factor | 194 IU/L |
| Luteinizing Hormone (LH) | 500 mIU/mL |
| Follicle-stimulating hormone (FSH) | 500 mIU/mL |
| Human Growth Hormone (hGH) | 100 ng/mL |
| TSH | 200 mIU/mL |
| Acetaminophen | 20 mg/dL |
| Acetylsalicylic Acid | 20 mg/dL |
| Ascorbic Acid | 20 mg/dL |
| Atropine | 20 mg/dL |
| Caffeine | 20 mg/dL |
| EDTA | 80 mg/dL |
| Ethanol | 1% |
| Gentisic Acid | 20 mg/dL |
| Glucose | 2 g/dL |
| Salicylic Acid | 20 mg/dL |
CONCLUSION:
The material submitted in this premarket notification is complete and supports the basis for substantial equivalence to the Roche ELECSYS® HCG + Beta Test System (K003178). The labelling is sufficient and satisfies the requirements of 21 CFR Part 809.10.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, but with a more abstract and modern design.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 6, 2013
DiaSorin Inc. C/O Mari Meyer Director, Regulatory Affairs 1951 Northwestern Avenue P.O. Box 285 STILLWATER MN 55082
Re: K131037
Trade/Device Name: DiaSorin LIASON® XL HCG Regulation Number: 21 CFR 862.1155 Regulation Name: Human chorionic gonadotropin (HCG) test system Regulatory Class: II Product Code: DHA Dated: August 14, 2013 Received: August 21, 2013
Dear Ms. Meyer:
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 electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact 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/ResourcesforYou/Industry/default.htm. 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
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Indications for Use
510(k) Number (if known): K131037
Device Name: LIAISON® XL HCG
Indications for Use: The DiaSorin LIAISON® XL HCG assay uses chemiluminescent immunoassay (CLIA) technology on the LIAISON® XL Analyzer for the quantitative determination of total human chorionic gonadotropin (hCG and BhCG) in human serum for early detection of pregnancy. Total hCG is the measurement of intact and betahCG.
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 (OIR)
Denise Johnson-lyles -S 2013.09.06 07:55:38 -04'00'
Division Sign-Off Office of In Vitro Diagnostics and Radiological Health
510(k)k131037
§ 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.