(45 days)
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No
The summary describes a quantitative assay and analyzer system for measuring specific biomarkers in urine. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML applications in medical devices. The performance studies focus on comparing the assay's results to existing methods, not on validating an AI/ML algorithm.
No.
The device is an assay for measuring microalbumin, creatinine, and albumin/creatinine ratio in urine, intended for screening and monitoring microalbuminuria, not for providing therapy or treatment.
Yes
The device "is intended for use in both screening for, and monitoring treatment of, microalbuminuria," which are diagnostic activities.
No
The device description explicitly states it is a "selfcontained reagent/instrument system" and is designed to be used with the "DCA 2000+ Analyzer". This indicates it is a hardware-based 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 "measurement of microalbumin, creatinine and albumin/creatinine ratio in urine." This involves testing biological samples (urine) in vitro (outside the body) to provide information for medical purposes (screening for and monitoring microalbuminuria in diabetic patients).
- Device Description: It describes a "self-contained reagent/instrument system" designed for use in laboratories and point-of-care settings. This aligns with the nature of IVD devices, which are used to perform tests on biological samples.
- Performance Studies: The summary of performance studies mentions comparing results to "currently used tests for microalbumin and creatinine," which are also IVD tests.
- Predicate Devices: The listed predicate devices are all methods and systems for measuring albumin and creatinine in biological samples, further confirming the IVD nature of this device.
The core function of the device is to analyze a biological sample (urine) to provide diagnostic information, which is the defining characteristic of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The DCA 2000+ Microalbumin/Creatinine Assay is a professional use device for the measurement of microalbumin, creatinine and albumin/creatinine ratio in urine. Testing for microalbuminuria (low concentrations of albumin in the urine) is recommended in patients with insulin-dependent diabetes mellitus (IDDM) as well as patients with non-insulin dependent diabetes mellitus (NIDDM). This assay is intended for use in both screening for, and monitoring treatment of, microalbuminuria.
Product codes
75 JIR, 75 CGX
Device Description
The DCA 2000+ Microalbumin/Creatinine Assay is a convenient, quantitative method for measuring low concentrations of albumin (microalbumin), creatinine and albumin/creatinine ratio in urine. The DCA 2000+ Microalbumin/Creatinine Assay is designed to be used with the DCA 2000+ Analyzer and the DCA 2000+ Microalbumin/Creatinine Control Kit. It is self-contained reagent/instrument system that is suitable for use in decentralized, or point-of-care laboratories such as physician office laboratories, clinics and hospitals.
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
professional use device / decentralized, or point-of-care laboratories such as physician office laboratories, clinics and hospitals.
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)
The performance of the DCA 2000 + Microalbumin/Creatinine Assay was studied in clinical settings by typical users of the system and results compared to currently used tests for microalbumin and creatinine. The studies demonstrated that typical users in decentralized, point-of-care laboratories can obtain clinical test results that are substantially equivalent to current methods.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Incstar® Antibody Reagent Set for Microalbumin SPQ™ Test System; Diagnostic Products Corporation Double Antibody Albumin RIA for microalbuminuria; Pharmacia Albumin RIA; Behring Turbitimer semiautomated method for albumin; Beckman Array® nephelometric method for albumin; Roche® Reagent for CREATININE [Roche Cobas™-Mira]; automated Jaffe methods for Hitachi, Olympus and Dupont Dimension analyzers; Sigma manual alkaline picrate method
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 862.1645 Urinary protein or albumin (nonquantitative) test system.
(a)
Identification. A urinary protein or albumin (nonquantitative) test system is a device intended to identify proteins or albumin in urine. Identification of urinary protein or albumin (nonquantitative) is used in the diagnosis and treatment of disease conditions such as renal or heart diseases or thyroid disorders, which are characterized by proteinuria or albuminuria.(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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SEP 2 7 1986
510(k) SAFETY AND EFFECTIVENESS SUMMARY
| Prepared: | August 9, 1996 |
|---|---|
| Submitter: | Bayer Corporation, Business Group Diagnostics |
| Address: | 1884 Miles Avenue, P. O. Box 70 |
| Elkhart, IN 46515 | |
| (219) 262-6929 | |
| Contact: | Rosanne M. Savol, R.A.C. |
| Manager, Regulatory Affairs | |
| Device: | Trade/Proprietary Name: DCA 2000®+Microalbumin/Creatinine Assay |
| Common/Usual Name: Test for microalbumin in urine | |
| Test for creatinine in urine | |
| Document Control Number: K96 | |
| Classification | Division of Clinical Laboratory Devices |
| Panel - Clinical Chemistry and Toxicology | |
| Classification Code - 75 JIR (Urinary Protein or Albumin) | |
| 75 CGX (Alkaline Picrate, Colorimetry, | |
| Creatinine) | |
| Predicate Devices: | Incstar® Antibody Reagent Set for Microalbumin SPQ™ Test |
| System; Diagnostic Products Corporation Double Antibody | |
| Albumin RIA for microalbuminuria; Pharmacia Albumin RIA; | |
| Behring Turbitimer semiautomated method for albumin; Beckman | |
| Array® nephelometric method for albumin; Roche® Reagent for | |
| CREATININE [Roche Cobas™-Mira]; automated Jaffe methods | |
| for Hitachi, Olympus and Dupont Dimension analyzers; Sigma | |
| manual alkaline picrate method | |
| Device Description: | The DCA 2000+ Microalbumin/Creatinine Assay is a |
| convenient, quantitative method for measuring low concentrations | |
| of albumin (microalbumin), creatinine and albumin/creatinine | |
| ratio in urine. The DCA 2000+ Microalbumin/Creatinine Assay | |
| is designed to be used with the DCA 2000+ Analyzer and the |
1
DCA 2000+ Microalbumin/Creatinine Control Kit. It is selfcontained reagent/instrument system that is suitable for use in decentralized, or point-of-care laboratories such as physician office laboratories, clinics and hospitals.
Intended Use: The DCA 2000+ Microalbumin/Creatinine Assay is a professional use device for the measurement of microalbumin, creatinine and albumin/creatinine ratio in urine. Testing for microalbuminuria (low concentrations of albumin in the urine) is recommended in patients with insulin-dependent diabetes mellitus (IDDM) as well as patients with non-insulin dependent diabetes mellitus (NIDDM). This assay is intended for use in both screening for, and monitoring treatment of, microalbuminuria.
Technological Characteristics:
The DCA 2000+ Microalbumin/Creatinine Assay employs an immunoassay for the microalbumin test and an alkaline, colorimetric assay for the creatinine test. The reagents are contained in a reagent cartridge. The DCA 2000+ Analyzer controls the reaction steps and automatically performs all the measurements and calculations. Results are displayed on the instrument screen. The system is factory calibrated.
Assessment of Performance:
The performance of the DCA 2000 + Microalbumin/Creatinine Assay was studied in clinical settings by typical users of the system and results compared to currently used tests for microalbumin and creatinine. The studies demonstrated that typical users in decentralized, point-of-care laboratories can obtain clinical test results that are substantially equivalent to current methods.
Conclusion:
The DCA 2000+ Microalbumin/Creatinine Assay is a convenient method for measuring microalbumin and creatinine in urine. Studies show that it can be used in decentralized and point-of-care laboratories and provide clinical results comparable to other test methods in current clinical laboratory practice.