(31 days)
Not Found
No
The summary describes a chemical reagent and its performance on automated clinical chemistry analyzers. There is no mention of AI or ML in the intended use, device description, or performance studies. The "rate assay" is a chemical kinetics measurement, not an AI/ML algorithm.
No
This device is an in vitro diagnostic test used to measure protein levels in urine and cerebrospinal fluid for diagnostic purposes, not to directly treat a disease or condition.
Yes
The 'Intended Use / Indications for Use' section explicitly states that the measurements obtained by this device are "used in the diagnosis and treatment of a variety of diseases".
No
The device is described as a reagent (in vitro test) used on automated clinical chemistry analyzers, indicating it is a physical component (chemical substance) and not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The description explicitly states it is an "In vitro test for the quantitative determination of protein in urine and cerebrospinal fluid". It also details how the measurements are used in the "diagnosis and treatment of a variety of diseases". This directly aligns with the definition of an IVD, which is used to examine specimens from the human body to provide information for diagnosis, treatment, or prevention of disease.
- Device Description: The description further clarifies that it's an "in vitro test" and describes how it analyzes samples (urine and CSF) on automated clinical chemistry analyzers.
- Performance Studies: The performance studies described (precision and method comparison) are typical for evaluating the analytical performance of an IVD.
The key elements that confirm it's an IVD are the "in vitro test" designation and the use of the results for "diagnosis and treatment".
N/A
Intended Use / Indications for Use
In vitro test for the quantitative determination of protein in urine and cerebrospinal fluid on Roche automated clinical chemistry analyzers.
Measurements obtained by this device are used in the diagnosis and treatment of a variety of diseases involving the liver, kidney or bone marrow as well as metabolic or nutritional disorders.
Protein measurements in urine are 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.
CSF protein measurements are used in diagnosis and treatment of conditions such as meningitis, brain tumors and infections of the central nervous systems.
Product codes (comma separated list FDA assigned to the subject device)
JGQ
Device Description
The Roche/Hitachi Urinary/CSF Protein reagent is an in vitro test for the quantitative determination of protein in urine and cerebrospinal fluid on Roche automated clinical chemistry analyzers.
The modified device includes both the original endpoint assay and the additional rate assay. The new rate assay was developed to provide absorbance limits that will flag high protein samples with high absorbance, thus eliminating the need for prescreening samples for high protein levels. The endpoint assay still requires sample prescreening or inspection of the Reaction Monitor display after completion of the reaction to ensure that high samples are detected and appropriately diluted for rerun. The attached labeling provides a more complete description of this potential high sample / prozone effect.
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)
Substantial equivalency - Similarities:
Performance characteristics:
Precision:
Urine:
Within run and Between run:
- Human urine: Within-run (n = 21) Mean 10.0 mg/dL, SD 0.52 mg/dL, CV 5.2%. Between-run (n = 10) Mean 12.0 mg/dL, SD 0.46 mg/dL, CV 3.8%.
- Control 1: Within-run (n = 21) Mean 21.7 mg/dL, SD 0.42 mg/dL, CV 1.9%. Between-run (n = 10) Mean 34.5 mg/dL, SD 0.60 mg/dL, CV 1.7%.
- Control 2: Within-run (n = 21) Mean 67.3 mg/dL, SD 0.66 mg/dL, CV 1.0%. Between-run (n = 10) Mean 114.37 mg/dL, SD 1.30 mg/dL, CV 1.1%.
CSF:
Within run and Between run:
- Control 1: Within-run (n = 20) Mean 23.1 mg/dL, SD 0.20 mg/dL, CV 0.9%. Between-run (n = 10) Mean 29.3 mg/dL, SD 0.30 mg/dL, CV 1.0%.
- Control 2: Within-run (n = 20) Mean 53.6 mg/dL, SD 0.36 mg/dL, CV 0.7%. Between-run (n = 10) Mean 90.2 mg/dL, SD 0.56 mg/dL, CV 0.6%.
Method comparison:
A comparison of the U/CSF Protein determination with Roche Diagnostics U/CSF Protein reagent using the rate application (y) with the same reagent using the endpoint application (x) gave the following correlations (mg/dL):
Urine samples:
- Passing/Bablok y = 0.988x - 0.434, r = 1.000
- Number of samples measured: 60
- The sample concentrations were between 1.7 and 3286.5 mg/dL.
- Statistics include all results (diluted and undiluted).
CSF samples:
- Passing/Bablok y = 0.984x + 0.480, r = 1.000
- Number of samples measured: 50
- The sample concentrations were between 5.8 and 110.2 mg/dL.
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).
Not Found
§ 862.1635 Total protein test system.
(a)
Identification. A total protein test system is a device intended to measure total protein(s) in serum or plasma. Measurements obtained by this device are used in the diagnosis and treatment of a variety of diseases involving the liver, kidney, or bone marrow as well as other metabolic or nutritional disorders.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.
0
OCT 1 9 2007
510(k) Summary - Roche/Hitachi Urinary/CSF Protein
Introduction and purpose of submission
Roche Diagnostics Corporation hereby submits this Special 510(k): Device Modification to provide notification of modifications to our Urine/CSF Protein test system. The reagent was originally cleared as an endpoint, turbidimetric assay for use as Roche/Hitachi Urinary/CSF Protein via K913615. Subsequent to this filing, a rate (kinetic) application was developed, in addition to the original endpoint assay, and applied to the Hitachi family of analyzers. This additional rate application did not involve any changes to the reagent formulation, and is the sole purpose of this Special 510(k).
1
510(k) Summary – Roche/Hitachi Urinary/CSF Protein,
Continued
| Submitter
name, address,
contact | Roche Diagnostics
9115 Hague Rd
Indianapolis IN 46250
(317) 521-7637
Contact person: Kerwin Kaufman
Date prepared: September 17, 2007 | | | |
|----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------|---------------------------|------------------------|
| Device Name | Proprietary name: Roche/Hitachi Urinary/CSF Protein
Common name: Total Protein
Classification name: Total Protein test system | | | |
| Classification | The FDA has classified Total protein test system in Class II. | | | |
| | Panel | Classification
Number | Classification Name | Regulation
Citation |
| | 75 Clinical
Chemistry | JGQ | Total Protein test system | 21 CFR 862.1635 |
| Establishment
registration | The establishment registration number for Roche Diagnostics GmbH
Penzberg is 9610529.
The establishment registration number for Roche Diagnostics Corporation
Indianapolis is 1823260. | | | |
| Device
Description | The Roche/Hitachi Urinary/CSF Protein reagent is an in vitro test for the
quantitative determination of protein in urine and cerebrospinal fluid on
Roche automated clinical chemistry analyzers.
The modified device includes both the original endpoint assay and the
additional rate assay. The new rate assay was developed to provide
absorbance limits that will flag high protein samples with high absorbance,
thus eliminating the need for prescreening samples for high protein levels.
The endpoint assay still requires sample prescreening or inspection of the
Reaction Monitor display after completion of the reaction to ensure that high
samples are detected and appropriately diluted for rerun. The attached
labeling provides a more complete description of this potential high sample /
prozone effect. | | | |
2
510(k) Summary – Roche/Hitachi Urinary/CSF Protein, Continued
| Intended use
and Summary | Intended Use
The Roche/Hitachi Urinary/CSF Protein reagent is an in vitro test for the
quantitative determination of protein in urine and cerebrospinal fluid on
Roche automated clinical chemistry analyzers. |
|----------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Summary
Protein measurements in urine are 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. |
| | CSF protein measurements are used in diagnosis and treatment of disease
conditions such as meningitis, brain tumors and infections of the central
nervous systems. |
| Predicate
Device | We claim substantial equivalence to the Hitachi Urinary/CSF Protein test
system cleared as K913615. |
| Substantial
equivalency –
Similarities | The table below indicates the similarities and differences between the
modified Urinary/CSF Protein reagent and the predicate device. |
3
510(k) Summary – Roche/Hitachi Urinary/CSF Protein, Continued
| Feature | Predicate device:
Roche/Hitachi Urinary/CSF Protein
K913615 | Modified device:
Roche/Hitachi Urinary/CSF
Protein, Additional RATE
Application |
|--------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|
| General | | |
| Intended Use | For the quantitative determination of
protein in urine (U) and cerebrospinal
fluid (CSF). | In vitro test for the quantitative
determination of protein in urine
and cerebrospinal fluid on Roche
automated clinical chemistry
analyzers. |
| Specimen | Urine and CSF | Same |
| Application | Endpoint assay | Endpoint and Rate application |
| Instrument
Platforms | Roche/Hitachi analyzers | Same |
| Test Principle | | |
| Reference
method | Turbidimetric | Same |
| Reagent information | | |
| Reagent
composition | R1: Sodium hydroxide 530 mmol/L,
EDTA sodium, 74 mmol/L
R2: Benzethonium chloride 32 mmol/L | Same |
| Stability - shelf
life and on-
board | 20-25 °C until expiration date
R1: 3 weeks on board at 2-12 °C
R2: 3 weeks on board at 2-12 °C | 15-25 °C until expiration date
R1: 21 days on board and
refrigerated on the analyzer
R2: 21 days on board and
refrigerated on the analyzer |
| Calibrator | Preciset U/CSF Protein
5 levels: 10, 20, 40, 80, 200 mg/dL
0.9 % NaCl used for a 0 mg/dL level | Same |
| Quality control | Commercially available urine and CSF
protein controls | Same |
| Traceability | This method has been standardized
against the National Bureau of
Standards Reference Material SRM
927a using the biuret method for the
quantitation of protein | Same |
4
510(k) Summary – Roche/Hitachi Urinary/CSF Protein, Continued
| Feature | Predicate device:
Roche/Hitachi Urinary/CSF Protein
K913615 | | | Modified device:
Roche/Hitachi Urinary/CSF Protein,
Additional RATE Application | | | | | | | |
|-----------------------------|-------------------------------------------------------------------|----------------------|-------------|---------------------------------------------------------------------------------------|---------------------|---------------------|----------------------|---------|----------------------|-------------|---------|
| Performance characteristics | | | | | | | | | | | |
| Precision | Urine: (data from K913615 labeling, page 33) | | | Urine:
Within run and Between run: | | | | | | | |
| | | Within-run (n = 120) | | | Within-run (n = 21) | | Between-run (n = 10) | | | | |
| | Sample | Mean
mg/dL | SD
mg/dL | CV
% | Sample | Mean
mg/dL | SD
mg/dL | CV
% | Mean
mg/dL | SD
mg/dL | CV
% |
| | Control 1 | 8.2 | 0.53 | 6.4 | Human urine | 10.0 | 0.52 | 5.2 | 12.0 | 0.46 | 3.8 |
| | Control 2 | 22.4 | 0.30 | 1.4 | Control 1 | 21.7 | 0.42 | 1.9 | 34.5 | 0.60 | 1.7 |
| | Control 3 | 182.4 | 0.90 | 0.5 | Control 2 | 67.3 | 0.66 | 1.0 | 114.37 | 1.30 | 1.1 |
| | | Total (n = 120) | | | | | | | | | |
| | Sample | Mean
mg/dL | SD
mg/dL | CV
% | | | | | | | |
| | Control 1 | 8.2 | 0.65 | 7.9 | | | | | | | |
| | Control 2 | 22.4 | 0.55 | 2.5 | | | | | | | |
| | Control 3 | 182.4 | 1.60 | 0.9 | | | | | | | |
| | CSF: (data from K913615 labeling, page 33) | | | CSF:
Within run and Between run: | | | | | | | |
| | | Within-run | | | | | | | | | |
| | Sample | Mean
mg/dL | SD
mg/dL | CV
% | | Within-run (n = 20) | | | Between-run (n = 10) | | |
| | | | | | Sample | Mean
mg/dL | SD
mg/dL | CV
% | Mean
mg/dL | SD
mg/dL | CV
% |
| | Control 1 (n=120) | 11.4 | 0.42 | 3.7 | Control 1 | 23.1 | 0.20 | 0.9 | 29.3 | 0.30 | 1.0 |
| | Control 2 (n=119) | 23.8 | 0.31 | 1.3 | Control 2 | 53.6 | 0.36 | 0.7 | 90.2 | 0.56 | 0.6 |
| | Control 3 (n=119) | 81.0 | 0.60 | 0.7 | | | | | | | |
| | | Total | | | | | | | | | |
| | Sample | Mean
mg/dL | SD
mg/dL | CV
% | | | | | | | |
| | Control 1 (n=120) | 11.4 | 0.59 | 5.1 | | | | | | | |
| | Control 2 (n=119) | 23.8 | 0.49 | 2.0 | | | | | | | |
| | Control 3 (n=119) | 81.0 | 0.74 | 0.9 | | | | | | | |
Substantial equivalency – Similarities
Continued on next page
:
5
510(k) Summary - Roche/Hitachi Urinary/CSF Protein, Continued
| Feature | Predicate device:
Roche/Hitachi Urinary/CSF Protein
K913615 | Modified device:
Roche/Hitachi Urinary/CSF Protein,
Additional RATE Application |
|-------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Measuring
range | Endpoint Assay:
2-200 mg/dL | Endpoint Assay:
2-200 mg/dL |
| | If results exceed the upper limit of the
measuring range, dilute the specimen
with isotonic saline and repeat the | Rate Assay:
6-200 mg/dL |
| | assay. | Determine samples with U/CSF
protein concentrations > 200 mg/dL
(2000 mg/L) via the rerun function.
On instruments without rerun
function, manually dilute samples
with 0.9% NaCl. Multiply the
result by the appropriate dilution
factor. |
| Lower
detection limit | 2 mg/dL | Endpoint Assay:
2 mg/dL |
| | | Rate Assay
6 mg/dL |
| Expected
values
(literature
reference) | Urine Random: