(20 days)
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No
The description focuses on standard reflectance photometry and mechanical improvements, with no mention of AI or ML algorithms for analysis or interpretation.
No
The device is described as an "in-vitro semi-quantitative determination" device used to measure chemical constituents of urine, indicating it is for diagnostic purposes, not for treating a condition.
Yes
The text explicitly states "The Roche Diagnostics, Boehringer Mannheim Chemstrip 101 Urine Analyzer is a reflectance photometer for in-vitro semi-quantitative determination of the following urine analytes" and "an automated urinalysis system is a device intended to measure certain of the physical properties and chemical constituents of urine by procedures that duplicate manual urinalysis systems. This device is used in conjunction with certain materials to measure a variety of urinary analytes," clearly indicating its use in diagnosing conditions through analysis of biological samples.
No
The device description explicitly states it is a "reflectance photometer" and details hardware modifications (calibration fail-safe, automated test strip holder, rotating reader head). This indicates it is a physical device with hardware components, not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The description explicitly states it's for "in-vitro semi-quantitative determination of the following urine analytes." "In-vitro" means "in glass" or "outside the body," which is a key characteristic of IVDs. It also lists specific analytes measured in urine, a biological sample.
- Device Description: It further clarifies that it's for "in-vitro semi-quantitative reading of Chemstrip 10 UA urine test strips." This reinforces its use with a diagnostic reagent (the test strips) to analyze a biological sample (urine).
- Regulatory Definition: The text references the Code of Federal Regulations, Title 21 (Food and Drugs), Part 862.2900, which defines an automated urinalysis system as a device intended to measure properties and constituents of urine. This device fits that description.
Therefore, based on the provided information, the Roche Diagnostics, Boehringer Mannheim Chemstrip 101 Urine Analyzer is clearly an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Roche Diagnostics, Boehringer Mannheim Chemstrip 101 Urine Analyzer is a reflectance photometer for in-vitro semi-quantitative determination of the following urine analytes: specific gravity, pH, leukocytes, nitrite, glucose, ketones, urobilinogen, bilirubin and blood.
According to the Code of Federal Regulations, Title 21 (Food and Drugs), Part 862.2900, an automated urinalysis system is a device intended to measure certain of the physical properties and chemical constituents of urine by procedures that duplicate manual urinalysis systems. This device is used in conjunction with certain materials to measure a variety of urinary analytes.
Product codes (comma separated list FDA assigned to the subject device)
KQO, CDM, CEN, JIL, JIN, JIO, JIR, JJB, JMT, JRE, LJX
Device Description
The Chemstrip 101 Urine Analyzer is a reflectance photometer intended for in-vitro semi-quantitative reading of Chemstrip 10 UA urine test strips for the following analytes: specific gravity, pH, leukocytes, nitrite, protein, glucose, ketones, urobilinogen, bilirubin and blood.
The modifications which have been incorporated into the Chemstrip 101 Urine Analyzer are:
1.) an additional calibration fail-safe mechanism;
2.) an automated test strip holder;
3.) a rotating reader head, and
4.) increased results memory capacity
The Chemstrip 101 contains a fail-safe mechanism which prevents a test from being performed after the weekly instrument calibration limit. The device software will prompt the user, via a message display, to "REPEAT CALIBRATION" every 7 days after the last valid calibration. This fail-safe will not allow the user to run a test strip until calibration is performed.
The Chemstrip 101 has eliminated the manual test strip tray by incorporating a motor driven (automated) test strip tray. The user will place the strip on the motorized test tray and the device will automatically move the tray into the instrument for measurement.
The Chemstrip 101 utilizes the same light source (Light Emitting Diodes) and technology (reflectance photometry) as the original analyzer, but the modified device incorporates one reader head since the strip holder is capable of moving the test strip into position under the LEDs for analyte measurement.
The Chemstrip 101 incorporates the ability to store up to 100 sample results with the option of reprinting the results from memory.
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
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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)
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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.
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 862.2900 Automated urinalysis system.
(a)
Identification. An automated urinalysis system is a device intended to measure certain of the physical properties and chemical constituents of urine by procedures that duplicate manual urinalysis systems. This device is used in conjunction with certain materials to measure a variety of urinary analytes.(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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OCT 2 7 1998