(121 days)
The HemoChek Urine Collection Kit is a prescription device intended to collect a urine specimen in midstream or by dipping the absorbent pad in a cup containing urine, contain the specimen, and preserve the specimen after collection and during mailing from the collection area to the laboratory for testing of creatinine and microalbumin concentrations.
The HemoChek Urine Collection Kit is a device used by a person under the supervision of a trained health care professional to obtain a urine specimen midstream or by dipping the absorbent pad in a cup of urine, contain the specimen, and preserve the specimen after collection and during mailing to the laboratory for testing of creatinine and microalbumin concentrations. The device consists of the following:
- A collector pad holder/handle with a collector pad and a protective cover over the pad, contained in a sealed "peel-apart" plastic envelope. The collector pad holder/ handle itself consists of two parts, a collector pad holder and a collector pad slider. The collector pad is held in the holder/handle by a pin in the slider that fits into a hole in the collector pad, and by the holder, which keeps the pad from falling off the pin. The slider has a round indicator port in it. A blue color appears in this indicator port when a sufficient amount of urine has been collected.
- A Specimen Tube with a screw-on lid, containing preservative fluid.
- A clear plastic sealed envelope that contains both of the above items.
- A Patient Identification Card which contains the patient's name, address, Social Security Number, Insurance information, the Doctor's name and a bar-coded label which is peeled off and attached to the Collection Tube after the sample has been taken.
- A set of instructions.
- A zip lock bag into which the Specimen Tube is placed after the sample has been taken.
- A mailer into which the zip lock bag is placed.
- A polyethylene mailing envelope which contains all of the above items and is used to mail the HemoChek Urine Collection Kit to the patient.
The provided text describes a 510(k) summary for the HemoChek Urine Collection Kit, a device intended for collecting and preserving urine specimens for laboratory testing of creatinine and microalbumin concentrations.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria or a detailed table of exact performance metrics. Instead, the "Summary of Device Testing" section provides a qualitative statement about the device's performance relative to preserved urine.
| Acceptance Criterion (Inferred) | Reported Device Performance |
|---|---|
| Equivalence of collected specimen to preserved urine | "The test results demonstrated that the samples collected with the HemoChek device produce substantially the same results as specimens of preserved and unpreserved urine" when tested for creatinine and microalbumin concentrations. This implies that the device's collection and preservation method maintains the integrity of these analytes comparable to established methods. |
| Suitability for intended use (collection and preservation) | The study's conclusion, "HemoChek Urine Collection Kit is substantially equivalent to legally marketed predicate devices and effective for its intended use," suggests that the device successfully performs its core functions of collection and preservation without negatively impacting the analytical results. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the exact sample size ("number of urine pools" or "number of specimens") used for the testing. It vaguely states: "several tests were conducted from the same urine pool".
- Data Provenance: The document does not provide information on the country of origin of the data or whether the study was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
The document does not mention the involvement of experts to establish a "ground truth" in the context of clinical interpretation or diagnosis. The "ground truth" in this study refers to the chemical concentrations of creatinine and microalbumin in urine specimens. This "ground truth" would be established by laboratory analysis using validated assays on both HemoChek collected samples and comparator (preserved and unpreserved) urine samples. It is implied that standard laboratory practices and accredited testing methods were used to determine these concentrations, but details about the specific laboratory or personnel qualifications are not provided.
4. Adjudication Method for the Test Set
Not applicable. This study focuses on the analytical performance of the collection and preservation method for specific biochemical markers, not on the interpretation of medical images or diagnostic decisions that would typically require an adjudication method among experts.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. An MRMC study is typically used to assess the impact of an AI algorithm on human reader performance for tasks like diagnosis or detection. This document describes the evaluation of a physical urine collection and preservation device, not an AI algorithm, and therefore an MRMC study is not relevant or mentioned.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. This device is a physical urine collection kit, not an algorithm. The "standalone performance" in this context refers to the device's ability to collect and preserve urine specimens such that the analytes within remain stable for subsequent laboratory testing, which is implicitly what the "Summary of Device Testing" addresses.
7. Type of Ground Truth Used
The ground truth used was laboratory analytical results for creatinine and microalbumin concentrations. The comparison was made between:
- Specimens collected with the HemoChek device
- Preserved urine specimens (presumably collected using a standard, established preservation method)
- Unpreserved urine specimens (presumably tested immediately or under controlled conditions)
The "ground truth" for the HemoChek device's performance was its ability to yield "substantially the same results" as these comparator samples.
8. Sample Size for the Training Set
Not applicable. This is a physical medical device (urine collection kit), not a machine learning model or algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
§ 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.