(141 days)
Bayer's "NEW MULTIPLES" Reagent Strips are firm plastic strips that contain reagent areas to test for low level protein (15 mg/dL albumin), high level protein (>30 mg/dL protein), creatinine, occult blood, glucose, ketone (acetoacetic acid), leukocytes, nitrite, pH, specific gravity, bilirubin, and urobilinogen. A protein to creatinine ratio is also determined. The strips are read visually by comparison to a color chart on the bottle label. The "NEW MULTIPLES" Reagent Strips can also be read instrumentally on the CLINITEK®50, CLINITEK® 100, CLINITEK® 200+ and CLINITEK® 500 Urine Chemistry Analyzers.
Bayer's "NEW MULTIPLES" Reagent Strips are intended for use in at-risk patient groups to assist diagnosis in the following areas: kidney function, carbohydrate metabolism (e.g., diabetes mellitus), urinary tract infections and liver function. The strips also measure physical characteristics, including acid-base balance and urine concentration. Test results can be used along with other diagnostic information to rule out certain disease states. Bayer's "NEW MULTIPLES" Reagent Strips are for professional use in Point -Of-Care locations such as physicians offices or clinics and centralized laboratory locations such as in hospitals.
Bayer's "NEW MULTIPLES" Reagent Strips are firm plastic strips for urinalysis that contain reagent areas for low level protein (15 mg/dL albumin), high level protein (>30 mg/dL protein), creatinine, blood, glucose, ketone (acetoaceticacid), nitrite, pH, specific gravity, bilirubin, and urobilinogen. A protein-to-creatinine ratio is also determined. New Multiples Reagent Strips are manually dipped into a urine specimen and "read" visually using a color chart. "NEW MULTIPLES" Reagent Strips may also be read instrumentally, using the CIINITEK® family of Urine Chemistry Analyzers. The method is designed for use with random, overnight or timed specimens. Semi-quantitative results are available within one minute.
The provided document describes a 510(k) submission for "NEW MULTIPLES" Reagent Strips for urinalysis. However, it does not contain explicit acceptance criteria or a detailed study proving the device meets specific performance thresholds with numerical data, such as sensitivity, specificity, or agreement percentages against a gold standard. Instead, it offers a general statement about performance assessment.
Here's a breakdown of the information that can be extracted or inferred based on your request, and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
MISSING: The document does not explicitly state numerical acceptance criteria (e.g., "The device must achieve >90% sensitivity"). It only generically states that performance was comparable.
Reported Device Performance (General Statements):
| Parameter Tested | Reported Device Performance |
|---|---|
| Overall | "The studies demonstrated that typical users in centralized and point-of-care laboratories can obtain clinical test results that are comparable to commonly used laboratory methods." |
| Overall | "Studies show that the product provides clinical results comparable to other test methods in current clinical practice." |
| Protein (low, high) & Creatinine | New reagent areas for these analytes were incorporated, and their performance is encompassed by the general statements above. |
2. Sample Size Used for the Test Set and Data Provenance
MISSING: The document does not specify the sample size (number of urine specimens) used for the performance assessment.
Data Provenance: The study was conducted "in clinical setting by typical users." This suggests prospective data collection, likely within US-based healthcare settings given the FDA submission. The document doesn't explicitly state the country of origin, but it's implied to be within the jurisdiction of the submitting company (Bayer Corporation, Elkhart, Indiana, USA).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
MISSING: The document does not specify the number of experts or their qualifications used to establish ground truth for the test set. It mentions comparison to "commonly used laboratory methods." This implies that the ground truth was established by these reference methods, likely performed by trained laboratory personnel.
4. Adjudication Method for the Test Set
MISSING: The document does not describe any adjudication method (e.g., 2+1, 3+1, none). The comparison was made against "commonly used laboratory methods."
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
NO: The document does not describe a multi-reader, multi-case comparative effectiveness study with or without AI assistance. The device is a reagent strip for urinalysis, not an AI-powered diagnostic tool. The "readers" are either humans performing visual interpretation or the CLINITEK® Urine Chemistry Analyzers. The comparison is between the "NEW MULTIPLES" Reagent Strips (read visually or instrumentally) and "current MULTISTIX® 10 SG Reagent Strips and commonly used laboratory methods."
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
YES (conceptually, for instrumental reading): The device can be "read instrumentally, using the CLINITEK® family of Urine Chemistry Analyzers." When read instrumentally, this represents an "algorithm only" performance (the analyzer's internal algorithms interpreting the color changes). The performance of this instrumental reading was compared to existing methods.
7. Type of Ground Truth Used
The ground truth was established by "commonly used laboratory methods." This implies various laboratory reference tests relevant to each analyte (e.g., quantitative protein assays, enzymatic creatinine assays, culture for UTI, etc.) rather than expert consensus on visual interpretation, pathology, or outcomes data directly.
8. Sample Size for the Training Set
NOT APPLICABLE / MISSING: The document does not describe a "training set" in the context of machine learning or AI. The product is a chemical reagent strip. The development process would involve extensive R&D and formulation optimization, but not typically a "training set" for an learnable algorithm.
9. How the Ground Truth for the Training Set Was Established
NOT APPLICABLE / MISSING: As there's no mention of a training set in the AI sense, this information is not provided. The development of the reagent strips involved chemical principles and optimizations rather than data-driven algorithm training.
§ 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.