(31 days)
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No
The summary describes a standard immunoassay for measuring LH and does not mention any AI or ML components.
No.
The device is used for the quantitative measurement of lutenizing hormone (LH) in serum or plasma, which is a diagnostic purpose, not a therapeutic one.
Yes
The device is described as being for "quantitative measurement of lutenizing hormone (LH) in serum or plasma," which is a diagnostic measurement.
No
The device description clearly states it is a fluorogenic enzyme assay and describes physical components like a test module, solid phase antibody, and conjugate solutions, indicating it is a hardware-based immunoassay system, not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "quantitative measurement of lutenizing hormone (LH) in serum or plasma." Serum and plasma are biological specimens taken from the human body.
- Device Description: The description details a "fluorogenic enzyme assay" and a "sandwich binding immunoassay" that uses antibodies to detect LH in these biological samples.
- Principle of Operation: The assay works by analyzing components within the biological sample (serum or plasma) to determine the concentration of LH.
These characteristics align with the definition of an In Vitro Diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnostic purposes.
N/A
Intended Use / Indications for Use
OPUS hLH is a fluorogenic enzyme assay for use with the OPUS analyzers used in the quantitative measurement of lutenizing hormone (LH) in serum or plasma.
Product codes
862.1485
Device Description
OPUS hLH is based on the principle of sandwich binding immunoassay. Each test module contains a solid phase anti-LH polyclonal antibody immobilized onto glass fiber. An anti-LH monoclonal antibody/alkaline phosphatase conjugate solution and a wash/substrate soluiton (4-methylumbellifery|phosphate) are sealed in separate wells within the test module.
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)
Precision:
Intra-assay precision: three serum pools, 20 replicates each. %CV's ranged from 4.56% to 6.32%.
Inter-assay precision: three levels of two sets of control sera, assayed in triplicate twice a day for five days (total 30 replicates). %CV's ranged from 4.55% to 5.64%.
Interference: No interference detected by TSH up to 1,000 mIU/L, FSH up to 1,000 mIU/ml, and Prolactin up to 1,000 ng/ml. hOG at levels up to 50,000 mlU/ml and hGH at levels up to 1,000 ng/ml showed less than 0.6% crossreactivity.
Accuracy by Correlation: 143 serum samples ranging from 0.79-109 mlU/ml, compared to a commercially available immunoassay. Correlation coefficient of 0.98, y-intercept value of 1.06, and slope of 1.06.
Accuracy by Recovery: LH added at different concentrations to a normal human serum pool with known endogenous LH concentration, assayed in replicates of three. Percent recovery ranged from 95.3% to 98.1%.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 862.1485 Luteinizing hormone test system.
(a)
Identification. A luteinizing hormone test system is a device intended to measure luteinizing hormone in serum and urine. Luteinizing hormone measurements are used in the diagnosis and treatment of gonadal dysfunction.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.
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510(k) Summary of Safety and Effectiveness for OPUS hLH
Manufacturer Name, Address, phone number, contact name and date of 1. preparation.
Behring Diagnostics Inc. Manufacturer: 151 University Ave Westwood, MA 02090 / 617-320-3000 Contact name: Ruth C. Forstadt
Date of preparation: July 22, 1996
Device Name/Classification 2.
Reagents for hLH assay OPUS HLH
Classification number: Class II (862.1485)
3. Identification of the legally marketed device to which the submitter claims equivalence.
Abbott IMX LH test system
4. Proposed Device Description
OPUS hLH is based on the principle of sandwich binding immunoassay. Each test module contains a solid phase anti-LH polyclonal antibody immobilized onto glass fiber. An anti-LH monoclonal antibody/alkaline phosphatase conjugate solution and a wash/substrate soluiton (4-methylumbellifery|phosphate) are sealed in separate wells within the test module.
5. Proposed Device Intended Use
OPUS hLH is a fluorogenic enzyme assay for use with the OPUS analyzers used in the quantitative measurement of lutenizing hormone (LH) in serum or plasma.
Medical device to which equivalence is claimed and comparison 6. information:
The OPUS hLH test system is substantially equivalent in intended use to the Abbott IMX LH test system. Both products are in vítro diagnostic test systems intended for use as a quantitative measurement of human lutenizing hormone (LH) in serum or plasma. The Abbott IMX LH, like the proposed product, employs the principle of two site or sandwich
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immunoassay. Both methods use a labeled antibody for the quantitative measurement of lutenizing hormone (LH) in human serum or plasma. The OPUS hLH and Abbott IMX LH are both based on a six level calibrator system.
The OPUS hLH differs from the Abbott IMX LH in that the solid phase capture antibody is a mouse monoclonal in the Abbott test, while the solid phase capture antibody is a rabbit monoclonal in the OPUS test. Also, the Abbott IMX LH includes a tri-level control, where as the OPUS hLH test system does not include a control.
Proposed Device Performance Characteristics 7.
Precision of the OPUS hLH test system was evaluated on an OPUS Immunoassay System. Intra-assay precision was determined by the evaluation of three serum pools in replicates of 20 each. %CV's ranged from 4.56% to 6.32%.
Inter-assay precision was determined by the evaluation of three levels of two sets of control sera assayed in triplicate twice a day for five days for a total of thirty replicates. %CV's ranged from 4.55% to 5.64%.
No interference was detected by levels of TSH up to 1,000 mIU/L, FSH up to 1,000 mIU/ml and Prolactin up to 1,000 ng/ml when evaluated using OPUS hLH. hOG at levels up to 50,000 mlU/ml and hGH at levels up to 1,000 ng/ml showed less than 0.6% crossreactivity with the OPUS LH assay.
Accuracy by Correlation
OPUS hLH was compared to a commercially available immunoassay by evaluation of 143 serum samples ranging from 0.79-109 mlU/ml. A correlation coefficient of 0.98 was obtained with a y-intercept value of 1.06 and a slope of 1.06.
Accuracy by Recovery
Recovery was determined by adding LH at different concentrations to a normal human serum pool with a known endogenous LH concentration. The samples were assayed using OPUS hLH in replicates of three. Percent recovery ranged from 95.3% to 98.1%.