(72 days)
Not Found
Not Found
No
The description details a standard ELISA assay, a biochemical method, and does not mention any computational or algorithmic components indicative of AI/ML. The performance study is a simple linear regression comparison, not an AI/ML model evaluation.
No
The device is an in vitro diagnostic (IVD) assay designed to quantitatively measure CrossLaps™ in human urine, which is an indicator of bone resorption. It is used for diagnosis and monitoring, not for treating or preventing disease.
Yes
The device is described as an "ELISA assay" intended for "quantitative determination of CrossLaps™ in human urine," where "the measurement of CrossLaps™ is used as an indicator of human bone resorption." This directly points to its use in assessing a biological state for diagnostic purposes.
No
The device is an ELISA assay kit, which is a laboratory test kit containing reagents and physical components for performing a biochemical assay. It is not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the assay is "intended for the quantitative determination of CrossLaps™ in human urine." This is a classic definition of an in vitro diagnostic test – it's used to analyze a sample taken from the human body (urine) outside of the body ("in vitro") to provide information about a person's health status (as an "indicator of human bone resorption").
- Device Description: The "Device Description" further clarifies that the kit is used for the "quantitative measurement of Type I Collagen Telopeptide (CrossLaps™) in human urine" using an ELISA method. This describes the specific technology used to perform the in vitro analysis.
- Performance Studies: The "Summary of Performance Studies" describes a study comparing the device to a predicate device using human urine samples, which is typical for demonstrating the performance of an IVD.
The information provided clearly indicates that this device is designed to be used outside of the human body to analyze a biological sample for diagnostic purposes.
N/A
Intended Use / Indications for Use
The DSL ACTIVE CrossLaps™ ELISA assay is intended for the quantitative determination of CrossLaps™ in human urine. The measurement of CrossLaps™ is used as an indicator of human bone resorption.
Product codes
Not Found
Device Description
The DSL 10-1700 ACTIVE CrossLaps™ ELISA kit was developed for the quantitative measurement of Type I Collagen Telopeptide (CrossLaps™) in human urine. The ELISA format is a competitive binding protein assay. CrossLaps™ in the urine sample competes with antigen coated to the microtitration wells for the enzyme labelled CrossLaps™ antibody. CrossLaps™ in the sample binds to the enzvme labelled antibody displacing it from binding to the antigen coated wells. Separation of free from bound CrossLaps™ is achieved by aspirating and washing the wells. The resultant is analyzed in a spectrophotometer for bound absorbance. The amount of enzyme-labeled CrossLaps™ bound to the microtiter well is inversely proportional to the concentration of the CrossLaps™ present in the sample.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Urine samples from sixty individuals were collected and assayed using both methods. Samples were chosen based on expected levels so that samples with low, intermediate and high levels would be evaluated.
Summary of Performance Studies
To demonstrate substantial equivalence between the two assays, urine samples from sixty individuals were collected and assayed using both methods. Samples were chosen based on expected levels so that samples with low, intermediate and high levels would be evaluated. Linear regression analysis of the results obtained for the comparison gave the equation Y =3.18(X) + 16.69 with a correlation coefficient of (r) = 0.95.
Key Metrics
Correlation coefficient (r) = 0.95
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.1400 Hydroxyproline test system.
(a)
Identification. A hydroxyproline test system is a device intended to measure the amino acid hydroxyproline in urine. Hydroxyproline measurements are used in the diagnosis and treatment of various collagen (connective tissue) diseases, bone disease such as Paget's disease, and endocrine disorders such as hyperparathyroidism and hyperthyroidism.(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
Image /page/0/Picture/0 description: The image shows a stylized logo or symbol in black against a white background. It appears to be an abstract design, possibly representing letters or initials. The design features curved lines and shapes that create a sense of flow and connection. The logo has a modern and minimalist aesthetic.
Diagnostic Systems Laboratories, nc 445 Medical Center Boulevard Webster Texas 77598-4217 USA Tel 713.332.9678 Fax 713.554.4220
Customer Assistance Center Tel 800.231.7970 Fax 713.338.1895
KxO171
SUMMARY OF SAFETY AND EFFECTIVENESS
湖南 28 136
Name of Device: DSL 10-1700 ACTIVE CrossLaps™ ELISA Kit Classification Name: Enzymeimmunoassay, Type I Collagen Telopeptide Analyte Code and Name: Type I Collagen Telopeptide
Submitter: John Willis Diagnostic Systems Laboratories, Inc. 445 Medical Center Boulevard Webster. Texas 77598 Phone:713-332-9678
Date: March 15, 1996
The DSL ACTIVE CrossLaps™ ELISA kit was developed for the quantitative measurement of Type I Collagen Telopeptide (CrossLaps™) in human urine. The ELISA format is a competitive binding protein assay. CrossLaps™ in the urine sample competes with antigen coated to the microtitration wells for the enzyme labelled CrossLaps™ antibody. CrossLaps™ in the sample binds to the enzvme labelled antibody displacing it from binding to the antigen coated wells. Separation of free from bound CrossLaps™ is achieved by aspirating and washing the wells. The resultant is analyzed in a spectrophotometer for bound absorbance. The amount of enzyme-labeled CrossLaps™ bound to the microtiter well is inversely proportional to the concentration of the CrossLaps™ present in the sample.
The DSL ACTIVE CrossLaps™ ELISA assay is intended for the quantitative determination of CrossLaps™ in human urine. The measurement of CrossLaps™ is used as an indicator of human bone resorption.
The DSL 10-1700 ACTIVE CrossLaps™ ELISA is substantially equivalent to the OSTEX OSTEOMARK assay. Both kits are used in vitro as an indicator of human bone resorption.
To demonstrate substantial equivalence between the two assays, urine samples from sixty individuals were collected and assayed using both methods. Samples were chosen based on expected levels so that samples with low, intermediate and high levels would be evaluated. Linear regression analysis of the results obtained for the comparison gave the equation Y =3.18(X) + 16.69 with a correlation coefficient of (r) = 0.95.