(143 days)
The Stanbio Creatinine LiquiColor® test system is a device intended to measure creatinine levels in serum or urine. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.
The Creatinine LiquiColor® test kit is comprised of two reagents, Reagent 1 (R1) and Reagent 2. To calibrate the test kit, a calibrator is used that has values determined by a similar method.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Creatinine LiquiColor® device:
Acceptance Criteria and Device Performance
The provided document describes a 510(k) submission, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than setting new, explicit acceptance criteria for novel performance claims. However, the performance data presented implicitly sets the "acceptance criteria" by showing performance comparable to the predicate device and within generally accepted analytical limits for clinical assays.
Here's a table summarizing the reported performance, with the understanding that these values, by virtue of leading to substantial equivalence, implicitly served as the 'acceptance criteria' for this submission.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-|
| Method Comparison (Correlation with Predicate) | Serum: Correlation coefficient (r) ≥ ~0.99 (based on observed 0.9991) Regression slope (y) ≈ 1.0 (based on observed 1.4815x - 0.5831, acknowledging a notable slope difference, but still showing strong correlation). | Serum: r = 0.9991, regression equation: y = 1.4815x - 0.5831 |
| | Urine: Correlation coefficient (r) ≥ ~0.98 (based on observed 0.9854) Regression slope (y) ≈ 1.0 (based on observed 1.0545x + 0.3607, showing good agreement). | Urine: r = 0.9854, regression equation: y = 1.0545x + 0.3607 |
| Precision (Intra-assay CV%) | Low CV% (e.g.,
§ 862.1225 Creatinine test system.
(a)
Identification. A creatinine test system is a device intended to measure creatinine levels in plasma and urine. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.(b)
Classification. Class II.