(74 days)
Not Found
No
The device description details a chemical reaction and enzymatic process for determining HDL cholesterol. There is no mention of AI or ML in the device description, intended use, or performance studies. The performance studies focus on traditional statistical metrics like correlation and linear regression, not metrics typically associated with AI/ML model evaluation.
No
This device is an in vitro diagnostic device used for quantitative determination of HDL cholesterol, which is a diagnostic purpose, not a therapeutic one.
Yes
The "Intended Use / Indications for Use" section explicitly states that "The Roche UNIMATE HDL Direct reagent is an in vitro diagnostic device".
No
The device is a reagent, which is a chemical substance used in a laboratory test. It is not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
The document explicitly states in the "Intended Use / Indications for Use" section: "The Roche UNIMATE HDL Direct reagent is an in vitro diagnostic device intended for use in clinical and physician's office laboratories (POL) on COBAS MIRA systems for the quantitative determination of High Density Lipoprotein Cholesterol (HDL CHOL) in serum."
This statement clearly identifies the device as an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The Roche UNIMATE HDL Direct reagent is an in vitro diagnostic test for the quantitative determination of High Density Lipoprotein Cholesterol (HDL CHOL) in serum. UNIMATE HDL Direct is intended for use in clinical and physician's office laboratories (POL) on COBAS MIRA systems. Determination of HDL cholesterol is useful for early detection of an increased risk of atherosclerosis.
Product codes (comma separated list FDA assigned to the subject device)
CHH, LBR, JIS
Device Description
The Roche UNIMATE HDL Direct reagent is an in vitro diagnostic test for the quantitative determination of High Density Lipoprotein Cholesterol (HDL CHOL) in serum. UNIMATE HDL Direct is intended for use in clinical and physician's office laboratories (POL) on COBAS MIRA systems. Determination of HDL cholesterol is useful for early detection of an increased risk of atherosclerosis.
Low HDL levels are recognized as a strong and common risk factor for atherosclerotic Coronary Artery Disease (CAD). Therefore, determination of HDL cholesterol is routinely offered as part of a lipid profile. Usually VLDL and LDL are selectively precipitated from serum or plasma samples followed by determination of cholesterol in the HDL - containing supernatant. These techniques require a centrifugation step to remove the precipitated lipoproteins and thus cannot be fully automated. UNIMATE HDL Direct, however, allows for the direct specific determination of HDL cholesterol in the presence of LDL, VLDL and chylomicrons without any sample pretreatment, therefore, lending itself to automated routine analysis.
The principle of the Roche UNIMATE HDL Direct reagent is based on the absorbance of synthetic polymers and polyanions to the surface of lipoproteins. LDL, VLDL, and chylomicrons are transformed into a detergent-resistant form, whereas HDL is not. Combined actions of polymers, polyanions and detergent solubilizes cholesterol from HDL, but not from LDL, VLDL, and chylomicrons. Solubilized cholesterol is oxidized by the sequential enzymatic action of cholesterol esterase and cholesterol oxidase. The H,O, produced in this reaction is reacted with chromogens to form a colored dye. The increase in absorbance at 550 nm is directly proportional to the HDL cholesterol concentration of the sample.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
clinical and physician's office laboratories (POL)
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Comparative performance studies were performed at three different physician office laboratories (POLs) on a minimum of 50 split samples provided by each laboratory. Aliquots of each sample were also tested in-house at Roche Diagnostics Systems' (RDS) laboratory to establish a reference site for comparative purposes. The study utilized COBAS MIRA Systems in use at each of the POLs.
Sample size: For Site #1, n=50; for Site #2, n=59; for Site #3, n=65.
Source: split samples provided by each POL laboratory.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Comparative performance studies were performed at three different physician office laboratories (POLs) on a minimum of 50 split samples provided by each laboratory. Aliquots of each sample were also tested in-house at Roche Diagnostics Systems' (RDS) laboratory to establish a reference site for comparative purposes. The study utilized COBAS MIRA Systems in use at each of the POLs. The results obtained for each sample at each POL site were compared to results using the POL's usual method and to Roche UNIMATE HDL Direct reagent's results.
The sample results obtained at the POL user sites for the UNIMATE HDL Direct studies were compared to the RDS reference laboratory UNIMATE HDL Direct sample results and gave the following results:
Site #1: n = 50, Correlation r = 0.990, Linear Regression y = 1.03x - 0.03 mmol/L (-1.0 mg/dL)
Site #2: n = 59, Correlation r = 0.994, Linear Regression y = 1.06x - 0.07 mmol/L (-2.5 mg/dL)
Site #3: n = 65, Correlation r = 0.991, Linear Regression y = 0.97X - 0.03 mmol/L (-1.2 mg/dL)
The sample results obtained at the POL user sites for their usual methodologies were compared to the POL user sites UNIMATE HDL Direct sample results and gave the following correlations for each independent study:
Site #1: n = 50, Correlation r = 0.965, Linear Regression y = 0.86x + 0.12 mmol/L (4.7 mg/dL)
Site #2: n = 59, Correlation r = 0.986, Linear Regression y = 0.99x + 0.0 mmol/L (0.0 mg/dL)
Site #3: n = 65, Correlation r = 0.944, Linear Regression y = 1.07x - 0.16 mmol/L (-6.1 mg/dL)
Within-run testing of 20 replicates was performed on three serum pools and, on Roche N and Roche P controls. Total precision was determined by performing duplicate determinations twice a day over five days for a total of 20 determinations at each POL site. Each POL site achieved the NCEP goals of CVs = 42 mg/dL, and SDs of
§ 862.1475 Lipoprotein test system.
(a)
Identification. A lipoprotein test system is a device intended to measure lipoprotein in serum and plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.(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.
0
Image /page/0/Picture/1 description: The image shows the Roche logo. The logo consists of the word "Roche" in bold, sans-serif font, enclosed within a hexagon. The hexagon is outlined in black, and the word "Roche" is also in black.
K973369 510(k) Summary
ROCHE UNIMATE HDL DIRECT REAGENT
In accordance with the Safe Medical Devices Act of 1990, a 510(k) summary is provided as outlined in 21 CFR 807.92.
I. Identification of 510(k) Sponsor:
Roche Diagnostic Systems, Inc. a subsidiary of Hoffmann-La Roche, Inc. Branchburg Township 1080 U.S. Highway 202 Somerville, New Jersey 08876-3771
510(k) Submission dated September 5, 1997
James W. Haynes Contact: Regulatory Affairs Associate Phone: (908) 253-7569 Fax: (908) 253-7547
II. Device Name:
The device name, including both the trade/proprietary name and the classification name are provided in the table below.
| Proprietary Name | Classification Name | Product Code | Regulation Number |
|---|---|---|---|
| Roche UNIMATE HDL Direct reagent | |||
| (with POL claim) | Cholesterol test system | CHH | 862.1175 |
Table 1
1
Identification of the legally marketed device to which the 510(k) sponsor claims III. equivalence:
The following table identifies the legally marketed device to which Roche Diagnostic Systems, Inc. claims equivalence.
| Proprietary Name | Predicate Product Name | K number | Date of substantial equivalence |
|---|---|---|---|
| Roche UNIMATE HDL | |||
| Direct reagent | |||
| (with POL claim) | Roche UNIMATE HDL Direct | ||
| reagent | K971902 | 6/16/97 |
Table 2
IV. Description of the Device/Statement of Intended Use:
The Roche UNIMATE HDL Direct reagent is an in vitro diagnostic test for the quantitative determination of High Density Lipoprotein Cholesterol (HDL CHOL) in serum. UNIMATE HDL Direct is intended for use in clinical and physician's office laboratories (POL) on COBAS MIRA systems. Determination of HDL cholesterol is useful for early detection of an increased risk of atherosclerosis.
Low HDL levels are recognized as a strong and common risk factor for atherosclerotic Coronary Artery Disease (CAD). Therefore, determination of HDL cholesterol is routinely offered as part of a lipid profile. Usually VLDL and LDL are selectively precipitated from serum or plasma samples followed by determination of cholesterol in the HDL - containing supernatant. These techniques require a centrifugation step to remove the precipitated lipoproteins and thus cannot be fully automated. UNIMATE HDL Direct, however, allows for the direct specific determination of HDL cholesterol in the presence of LDL, VLDL and chylomicrons without any sample pretreatment, therefore, lending itself to automated routine analysis.
The principle of the Roche UNIMATE HDL Direct reagent is based on the absorbance of synthetic polymers and polyanions to the surface of lipoproteins. LDL, VLDL, and chylomicrons are transformed into a detergent-resistant form, whereas HDL is not. Combined actions of polymers, polyanions and detergent solubilizes cholesterol from HDL, but not from LDL, VLDL, and chylomicrons. Solubilized cholesterol is oxidized by the sequential enzymatic action of cholesterol esterase and cholesterol oxidase. The H,O, produced in this reaction is reacted with chromogens to form a colored dye. The increase in absorbance at 550 nm is directly proportional to the HDL cholesterol concentration of the sample.
2
Summary of the technological characteristics of the new device in comparison to V. those of the predicate.
The Roche UNIMATE HDL reagent was previously cleared on June 16, 1997 (K971902) for use in clinical laboratories. The proposed labeling for the Roche UNIMATE HDL reagent has been modified to include the use of this product in physician office laboratories.
In addition, Roche has documented traceability to the National Reference System for Cholesterol by performing a direct comparison with the cholesterol reference method using fresh human specimens that cover the National Cholesterol Education Program (NCEP) medical decision points.
VI. Brief discussion of the clinical and nonclinical tests relied on for a determination of substantial equivalence:
Comparative performance studies were performed at three different physician office laboratories (POLs) on a minimum of 50 split samples provided by each laboratory. Aliquots of each sample were also tested in-house at Roche Diagnostics Systems' (RDS) laboratory to establish a reference site for comparative purposes. The study utilized COBAS MIRA Systems in use at each of the POLs. The results obtained for each sample at each POL site were compared to results using the POL's usual method and to Roche UNIMATE HDL Direct reagent's results.
The sample results obtained at the POL user sites for the UNIMATE HDL Direct studies were compared to the RDS reference laboratory UNIMATE HDL Direct sample results and gave the following results:
| Parameter | Site #1 | Site #2 | Site #3 |
|---|---|---|---|
| n = | 50 | 59 | 65 |
| Correlation | r = 0.990 | r = 0.994 | r = 0.991 |
| Linear Regression | y = 1.03x - 0.03 mmol/L | ||
| (-1.0 mg/dL) | y = 1.06x - 0.07 mmol/L | ||
| (-2.5 mg/dL) | y = 0.97X - 0.03 mmol/L | ||
| (-1.2 mg/dL) |
Table 3
3
The sample results obtained at the POL user sites for their usual methodologies were compared to the POL user sites UNIMATE HDL Direct sample results and gave the following correlations for each independent study:
| able
T
0 | A
t |
| ---------------- | -------- |
|---|
| Parameter | Site #1 | Site #2 | Site #3 |
|---|---|---|---|
| n = | 50 | 59 | 65 |
| Correlation | r = 0.965 | r = 0.986 | r = 0.944 |
| Linear Regression | y = 0.86x + 0.12 mmol/L | ||
| (4.7 mg/dL) | y = 0.99x + 0.0 mmol/L | ||
| (0.0 mg/dL) | y = 1.07x - 0.16 mmol/L | ||
| (-6.1 mg/dL) |
Within-run testing of 20 replicates was performed on three serum pools and, on Roche N and Roche P controls. Total precision was determined by performing duplicate determinations twice a day over five days for a total of 20 determinations at each POL site. Each POL site achieved the NCEP goals of CVs ≤ 6% at ≥ 42 mg/dL, and SDs of ≤ 2.50 mg/dL at