(24 days)
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No
The description details a chemiluminescent immunoassay based on antibody binding and light detection, with no mention of AI or ML algorithms for data analysis or interpretation.
No
This device is an in-vitro diagnostic (IVD) intended for the quantitative determination of LH in serum, which is a diagnostic purpose, not a therapeutic one.
Yes
The device is described as an "ACS LH2" for the "quantitative determination of LH in serum." This measured LH level helps diagnose conditions related to LH imbalances.
No
The device description clearly outlines a chemical assay involving reagents and paramagnetic particles, which are physical components, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "for the quantitative determination of LH in serum". This indicates that the device is used to analyze a biological sample (serum) outside of the body to provide information about a patient's health status (LH levels).
- Device Description: The description details a "two-site chemilumometric (sandwich) assay" that uses antibodies and paramagnetic particles to measure LH. This is a typical methodology for in vitro diagnostic tests.
- Performance Studies: The document includes data on accuracy and precision, which are standard performance metrics for IVD devices.
- Predicate Device: The mention of a "Predicate Device" (K910198; ACS LH Immunoassay) is a strong indicator that this device is being compared to a previously cleared IVD device, a common practice in regulatory submissions for IVDs.
All of these points align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The intended use of ACS LH2 is for the quantitative determination of LH in serum using the Ciba Corning Automated Chemiluminescence Systems.
Product codes
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Device Description
The Ciba Corning ASC LH2 assay is a two-site chemilumometric (sandwhich) assay which uses constant amounts of two antibodies that have specificity for the intact LH molecule. The first antibody or Lite Reagent is a monoclonal mouse anti-LH antibody labeled with acridinium ester. The second antibody or solid phase is a monoclonal mouse anti-LH antibody covalently coupled to paramagnetic particles. A direct relationship exists between the LH in a sample and the relative light units (RLUs) detected by the ACS:180 systems.
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
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Key Metrics
Sensitivity: The ACS LH2 assay measures LH concentrations up to 200 mIU/mL with a minimum detectable concentration of 0.07 mIU/mL.
Accuracy: For 689 samples in the range of 0.1 to 96.6 mIU/mL, the correlation between the ACS LH2 assay and the reference method assay is described by the equation: ACS LH2 = 0.93 (reference method) + 0.87. Correlation coefficient (r) = 0.97.
Precision: Total precision (Total % CV) ranged from 4.0 to 6.0.
Predicate Device(s)
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.
0
Company Confidential
Jul 21 1006
Summary of Safety and Effectiveness
As required by 21 CFR 807.92, the following 510(k) Summary is provided:
1. Submitter Information
| Contact person: | Thomas F. Flynn |
|---|---|
| ----------------- | ----------------- |
Address: Ciba Corning Diagnostics Corp. 63 North Street Medfield, MA 02052
Phone: 508 359-3877 FAX 508 359-3885 e-mail: thomas.flynn@cibadiag.com
Date Summary Prepared: May 24, 1996
2. Device Information
| Proprietary Name: | ACS LH2 Immunoassay |
|---|---|
| Common Name: | LH Immunoassay |
| Classification Name: | Class I, Luteinizing hormone test system, 21 CFR 862.1485 |
3. Predicate Device Information
| Name: | ACS LH Immunoassay |
|---|---|
| Manufacturer: | Ciba Corning Diagnostics Corp. |
| 510(k) Number: | K910198 |
4. Device Description
The Ciba Corning ASC LH2 assay is a two-site chemilumometric (sandwhich) assay which uses constant amounts of two antibodies that have specificity for the intact LH molecule. The first antibody or Lite Reagent is a monoclonal mouse anti-LH antibody labeled with acridinium ester. The second antibody or solid phase is a monoclonal mouse anti-LH antibody covalently coupled to paramagnetic particles. A direct relationship exists between the LH in a sample and the relative light units (RLUs) detected by the ACS:180 systems.
5. Statement of Intended Use
The intended use of ACS LH2 is for the quantitative determination of LH in serum using the Ciba Corning Automated Chemiluminescence Systems.
1
6. Summary of Technological Characteristics
The Ciba Corning LH2 assay is a non-competitive chemiluminescence assay
7. Performance Data
Sensitivity
The ACS LH2 assay measures LH concentrations up to 200 mIU/mL with a minimum detectable concentration of 0.07 mIU/mL.
Accuracy
For 689 samples in the range of 0.1 to 96.6 mIU/mL, the correlation between the ACS LH2 assay and the reference method assay is described by the equation:
ACS LH2 = 0.93 (reference method) + 0.87
Correlation coefficient (r) = 0.97
Precision
Total precision (Total % CV) ranged from 4.0 to 6.0.