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The Human Microalbumin kit for use on SPAPLUS kit is intended for the quantitative measurement of human albumin in human urine using the SPAPLUS turbidimetric analyser. Measurement of albumin in human urine is an aid in the diagnosis of renal disease. This test should be used in conjunction with other laboratory and clinical findings. For in vitro diagnostic use only.

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This document is a 510(k) premarket notification decision letter from the FDA for a medical device. It does not include detailed information about acceptance criteria or specific study results that prove the device meets those criteria.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, nor can I provide information on:

1. A table of acceptance criteria and the reported device performance
2. Sample size used for the test set and data provenance
3. Number of experts and qualifications for ground truth
4. Adjudication method
5. MRMC comparative effectiveness study results
6. Standalone performance results
7. Type of ground truth used
8. Sample size for the training set
9. How ground truth for the training set was established

The document primarily states the FDA's determination that the device, "Human Microalbumin kit for use on SPAPLUS kit," is substantially equivalent to legally marketed predicate devices. It lists the "Indications for Use" for the device, which is "intended for the quantitative measurement of human albumin in human urine using the SPAPLUS turbidimetric analyser. Measurement of albumin in human urine is an aid in the diagnosis of renal disease. This test should be used in conjunction with other laboratory and clinical findings. For in vitro diagnostic use only."

To obtain the information you requested, you would typically need to consult the full 510(k) submission summary or associated clinical/analytical study reports, which are not included in this decision letter.

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