(35 days)
No
The device description and performance studies focus on a homogeneous enzyme colorimetric assay and standard analytical validation methods, with no mention of AI or ML.
No.
This device is an in-vitro diagnostic test used for the quantitative determination of LDL-cholesterol, which aids in the diagnosis and treatment of lipid disorders. It does not directly provide therapy or treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that "Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases." This indicates its purpose is to aid in diagnosis.
No
The device is an in-vitro diagnostic assay consisting of chemical reagents (R1 and R2) for the quantitative determination of LDL-cholesterol. It is a physical product, not 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 LDL-cholesterol in human serum and plasma". This is the defining characteristic of an in vitro diagnostic device – it is used to examine specimens taken from the human body.
- Device Description: The description details the reagents used to perform the test on human serum and plasma samples.
- Intended User/Care Setting: It is listed as "Prescription Use", which is common for IVD devices used in a clinical setting.
The information provided clearly indicates that this device is designed to be used outside of the body (in vitro) to diagnose or aid in the diagnosis of conditions by analyzing human biological samples.
N/A
Intended Use / Indications for Use
The LDL-Cholesterol Gen. 3 assay is an in-vitro test for the quantitative determination of LDL-cholesterol in human serum and plasma on Roche/Hitachi cobas c systems. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.
Product codes
LBR
Device Description
The LDL-Cholesterol Gen. 3 assay is a homogeneous enzyme colorimetric assay which provides the quantitative measurement of LDL-cholesterol in human serum and plasma.
Reagents are packaged in a cassette labeled with their instrument positioning R1 (Reagent 1) and R2 (Reagent 2).
R1 contains Bis-trisb) buffer: 20.1 mmol/L, pH 7.0; 4-aminoantipyrine:0.98 mmol/L; ascorbic oxidase (AOD, Acremonium spec.): >= 66.7 µkat/L; peroxidase (recombinant from Basidiomycetes): >= 166.7 µkat/L; BSA: 4.0 g/L; preservative R2 contains MOPSC) buffer: 20.1 mmol/L, pH 7.0; EMSE: 2.16 mmol/L, cholesterol esterase (Pseudomonas spec.): >= 33.3 µkat/L; cholesterol oxidase (recombinant from E.coli)): >= 31.7 µkat/L; peroxidase (recombinant from Basidiomycetes): >= 333.3 µkat/L; BSA: 4.0 g/L; detergents; preservative
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Human serum and plasma
Indicated Patient Age Range
Not Found
Intended User / Care Setting
For prescription use only.
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
LoB Protocol: One analyte free sample was tested in five-fold determinations on two analyzers over three days, for a total of N=60 determinations. Three lots of reagent were used for testing. The LoB is determined as the 95th percentile of the 60 measured values.
LoD Protocol: Five low-analyte samples were measured in singlicate on two analyzers over three days. Three lots of reagent were used for testing.
LoQ Protocol: A low-level sample set of five samples were tested in five replicates per sample on five days with three reagent lots, one run per day on one analyzer. The mean, the SD, and the %CV of 5 days were calculated for each sample. The mean concentration was plotted versus the %CV and LoQ is determined based on the precision at 10% CV.
Precision: One analyzer and 3 reagent lots using 5 human serum sample pools and two control samples (4 aliquots per run, 1 run per day, 21 days).
Drug Interference: Two sample pools, containing a low (approximately 100 mg/dL) and high (approximately 400 mg/dL) concentration of LDL are used. These sample pools are divided into an appropriate number of aliquots. One aliquot is not spiked with the drugs and it is used as the reference sample for LDL concentration. The LDL concentration in the sample is determined with n = 3 measurements on a cobas c 501 analyzer. The other sample aliquots, with either the high or low LDL concentrations, are spiked with the respective amount of drug. The LDL concentration of the spiked aliquots are determined in triplicate and the mean of the triplicate determinations is compared to the LDL concentration determined for the reference aliquot (mean of n=3).
VLDL, HDL, Chylomicrons Interference:
HDL-cholesterol: Two sample pools, containing a low and high concentration of LDL were used. These sample pools were divided into two aliquots. One aliquot was not spiked with HDL and it was used as the reference sample for LDL concentration. The LDL concentration in the sample was determined with n = 3 measurements on a cobas c 501 analyzer. The other sample aliquot, with either the high or low LDL concentrations, was spiked with the respective amount of HDL. The LDL concentration of the spiked aliquots were determined in triplicate and the mean of the triplicate determinations was compared to the LDL concentration determined for the reference aliquot (mean of n=3).
VLDL-cholesterol: VLDL were isolated from fresh human serum by ultracentrifugation method. Two sample pools, containing a low and high concentration of LDL were used. The samples were spiked with increasing amounts of VLDL fraction with increasing amounts of VLDL concentrations. The sample pools were split into two aliquots. One aliquot was spiked with VLDL-fraction the second was diluted with 0.9% NaCl as the reference. The mean of the duplicate determinations is compared to the LDL concentration determined for the reference aliquot (mean of n=2).
Chylomicrons (Triglycerides): Chylomicrons were separated from fresh non-fasting human samples by centrifugation. Four sample pools, containing a low and high concentration of LDL were used. The samples were spiked with increasing amounts of chylomicrons. Triglycerides concentrations were measured in all samples. The sample pools were split into two aliquots. One aliquot was spiked with chylomicrons the second was diluted with 0.9% NaCl. The mean of the duplicate determinations was compared to the LDL concentration determined for the reference aliquot (mean of n=2). The four samples contain chylomicron concentrations >= 2000 mg/dL Triglycerides. Additional samples with lower concentrations of Chylomicron Triglycerides
§ 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
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
ROCHE DIAGNOSTICS OPERATIONS (RDO) NOEL MENCIAS REGULATORY AFFAIRS CONSULTANT 9115 HAGUE ROAD INDIANAPOLIS IN 46250
January 28, 2015
Re: K143691
Trade/Device Name: LDLC3 LDL-Cholesterol Gen.3 Regulation Number: 21 CFR 862.1475 Regulation Name: Lipoprotein test system Regulatory Class: I, Meets limitations of the exemption as per 21 CFR 862.9 (c)(4) Product Code: LBR Dated: December 23, 2014 Received: December 24, 2014
Dear Noel Mencias:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Katherine Serrano -S
For : Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K143691
Device Name LDLC3 LDL-Cholesterol Gen.3
Indications for Use (Describe)
The LDL-Cholesterol Gen. 3 assay is an in-vitro test for the quantitative determination of LDL-cholesterol in human serum and plasma on Roche/Hitachi cobas c systems. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| × Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
| Date prepared: | December 23, 2014 |
|---|---|
| Purpose of submission | In accordance with 21 CFR 807.87, Roche Diagnostics hereby submits official notification as required by Section 510(k) of the Federal Food, Drug and Cosmetics Act of our intention to market the device described in this Premarket Notification [510(k)]. This candidate device is a new reagent that was developed by Roche Diagnostics. The previous generation of reagent, LDL-Cholesterol plus 2nd generation, was cleared in 510(k) K974733 and serves as the predicate device. The candidate and predicate devices use the same calibrator and controls. Only the reagents differ. This submission presents data to support clearance of this new reagent. |
| Measurand | Lipoprotein |
| Type of test | Quantitative homogeneous enzyme colorimetric method |
| Applicant | Noel B. Mencias, Regulatory Affairs Consultant Roche Diagnostics 9115 South Hague Road Indianapolis, IN 46250 Telephone: (317) 521-3172 Fax: (317) 521-2324 Email: noel.mencias@roche.com |
| Candidate device names | Proprietary name: LDLC3 LDL-Cholesterol Gen. 3 Common name: LDL-Cholesterol Gen. 3 Classification name: Lipoprotein Test System (21 CFR 862.1475) |
510(k) Summary for LDLC3 LDL-Cholesterol Gen. 3
4
| Regulatory
| information | Product Code | Classification | Regulation | Panel |
|---|---|---|---|---|
| LBR | Class I | 21 CFR 862.1475 | ||
| (Lipoprotein test system) | Clinical | |||
| Chemistry | ||||
| 75 | ||||
| LDLC3 LDL-Cholesterol Gen. 3 meets the limitation of exemption per 21 | ||||
| CFR 862.9 (c)(4) - for cardiovascular risk. | ||||
| Intended use | The LDL-Cholesterol Gen. 3 assay is intended for use as an in vitro test for | |||
| the quantitative determination of LDL-Cholesterol in human serum and | ||||
| plasma on Roche/Hitachi cobas c systems. | ||||
| Indications for | ||||
| use | The LDL-Cholesterol Gen. 3 assay is an in-vitro test for the quantitative | |||
| determination of LDL-cholesterol in human serum and plasma on | ||||
| Roche/Hitachi cobas c systems. Lipoprotein measurements are used in the | ||||
| diagnosis and treatment of lipid disorders (such as diabetes mellitus), | ||||
| atherosclerosis, and various liver and renal diseases. | ||||
| Special | ||||
| conditions for | ||||
| use | For prescription use only. | |||
| Special | ||||
| instrument | ||||
| requirements | For use on the Roche/Hitachi cobas c clinical chemistry analyzer. | |||
| Continued on next page |
5
| Candidate
device
description | The LDL-Cholesterol Gen. 3 assay is a homogeneous enzyme colorimetric
assay which provides the quantitative measurement of LDL-cholesterol in
human serum and plasma.
Reagents are packaged in a cassette labeled with their instrument positioning
R1 (Reagent 1) and R2 (Reagent 2). |
|------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | R1 contains Bis-trisb) buffer: 20.1 mmol/L, pH 7.0; 4-
aminoantipyrine:0.98 mmol/L; ascorbic oxidase (AOD, Acremonium
spec.): ≥ 66.7 µkat/L; peroxidase (recombinant from Basidiomycetes):
≥ 166.7 µkat/L; BSA: 4.0 g/L; preservative R2 contains MOPSC) buffer: 20.1 mmol/L, pH 7.0; EMSE: 2.16
mmol/L, cholesterol esterase (Pseudomonas spec.): ≥ 33.3 µkat/L;
cholesterol oxidase (recombinant from E.coli)): ≥ 31.7 µkat/L;
peroxidase (recombinant from Basidiomycetes): ≥ 333.3 µkat/L;
BSA: 4.0 g/L; detergents; preservative |
| Predicate
device | Roche Diagnostics claims substantial equivalence to LDL-Cholesterol plus
2nd generation reagent on the cobas c 501. The reagent was originally cleared
in K974733 on the Boehringer Mannheim/Hitachi clinical chemistry
analyzers, and later cleared in a Special 510(k) K012287 on COBAS
INTEGRA. The application to the cobas c 501 analyzer was cleared on
October 3, 2006 in K060373/A001 following the FDA Policy Document
"Replacement Reagent and Instrument Family Policy – 12/11/2003." |
6
Substantial The following table compares the similar features of the candidate device to Equivalence – the predicate device that was cleared in 510(k) K974733. Assay Similarities
| Assay Comparison Similarities | |||
|---|---|---|---|
| Feature | Predicate Device: | ||
| LDL_C Cholesterol Plus 2nd | |||
| generation | Candidate Device: | ||
| LDLC3 LDL-Cholesterol Gen. 3 | |||
| Intended Use | In vitro test for the quantitative | ||
| determination of LDL-Cholesterol in | |||
| human serum and plasma on | |||
| Roche/Hitachi cobas c systems. | Same | ||
| Sample Types | Human Serum and Plasma | Same | |
| Test Principle | Homogenous enzymatic colorimetric | ||
| assav | Same | ||
| Reagent Shelf Life | |||
| Stability | 2-8 ℃ until expiration date | Same | |
| Reagent On-Board | |||
| Stability | 12 weeks | Same | |
| Measuring Range | 0.10 - 14.2 mmol/L (3.86 - 548 mg/dL) | 3.87 -549 mg/dL | |
| Lower Limit of | |||
| Measurement | LDL(lower detection limit) = 0.10 | ||
| mmol/L (3.866 mg/dL) | LoB = 0.406 mg/dL | ||
| LoD = 0.99 mg/dL | |||
| LoQ = 2.28 mg/dL | |||
| Expected Values | Adult levels: | ||
| Optimal: LoB Protocol: One analyte free sample was tested in five-fold determinations on two analyzers over three days, for a total of N=60 determinations. Three lots of reagent were used for testing. The LoB is determined as the 95th percentile of the 60 measured values. |
LoD Protocol: Five low-analyte samples were measured in singlicate on two analyzers over three days. Three lots of reagent were used for testing.
LoD was calculated as:
LoD = LoB + 1.653 x SDtot
Where:
SD ot = Square root [0.2 x ((SD sample 22 + (SD ample 2 + (SD sample 2 + (SD sample 2) + (SD sample 2) .
LoQ Protocol: A low-level sample set of five samples were tested in five replicates per sample on five days with three reagent lots, one run per day on one analyzer. The mean, the SD, and the %CV of 5 days were calculated for each sample. The mean concentration was plotted versus the %CV and LoQ is determined based on the precision at 10% CV.
The LoB, LoD, and LoQ claims represent the specifications for each.
| Result (mg/dL) | Claim (mg/dL) | |
|---|---|---|
| Limit of Blank | 0.406 | 3.87 |
| Limit of Detection | 0.99 | 3.87 |
| Limit of Quantitation | 2.28 | 3.87 |
11
Precision was determined according to CLSI EP5-A2 with one analyzer and 3 Precision reagent lots using 5 human serum sample pools and two control samples (4 aliquots per run, 1 run per day, 21 days). The following results were obtained:
Repeatability Summary
| Specimen | Mean
mg/dL (mmol/L) | SD mg/dL
(mmol/L) | CV
(%) |
|------------------------|------------------------|----------------------|-----------|
| Precinorm L | 104 (2.69) | 0.8 (0.02) | 0.7 |
| Precipath
HDL/LDL-C | 191 (4.93) | 1.2 (0.03) | 0.7 |
| Human Serum 1 | 11.7 (0.302) | 0.2 (0.004) | 1.2 |
| Human Serum 2 | 113 (2.93) | 0.8 (0.02) | 0.7 |
| Human Serum 3 | 303 (7.83) | 2.3 (0.06) | 0.7 |
| Human Serum 4 | 142 (3.67) | 1.2 (0.03) | 0.7 |
| Human Serum 5 | 526 (13.6) | 4.3 (0.11) | 0.8 |
Intermediate Precision
| Mean | SD mg/dL | CV | |
|---|---|---|---|
| Specimen | mg/dL (mmol/L) | (mmol/L) | (%) |
| Precinorm L | 104 (2.69) | 2.3 (0.06) | 2.3 |
| Precipath | |||
| HDL/LDL-C | 194 (5.02) | 4.2 (0.11) | 2.1 |
| Human Serum 1 | 12.2 (0.316) | 0.3 (0.008) | 2.5 |
| Human Serum 2 | 117 (3.03) | 2.3 (0.06) | 2.1 |
| Human Serum 3 | 315 (8.14) | 6.2 (0.16) | 1.9 |
| Human Serum 4 | 143 (3.71) | 3.1 (0.08) | 2.1 |
| Human Serum 5 | 530 (13.7) | 10.8 (0.28) | 2.0 |
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| Analytical
Specificity -
interference
from common
drugs.
Simvastatin,
Bezafibrate,
and Nicotinic
Acid | Sixteen commonly used drugs were examined for potential interference on
measurement with LDL-Cholesterol Gen.
Two sample pools, containing a low (approximately 100 mg/dL) and high
(approximately 400 mg/dL) concentration of LDL are used. These sample
pools are divided into an appropriate number of aliquots. One aliquot is not
spiked with the drugs and it is used as the reference sample for LDL
concentration. The LDL concentration in the sample is determined with n = 3
measurements on a cobas c 501 analyzer. |
|-------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The other sample aliquots, with either the high or low LDL concentrations,
are spiked with the respective amount of drug. The LDL concentration of the
spiked aliquots are determined in triplicate and the mean of the triplicate
determinations is compared to the LDL concentration determined for the
reference aliquot (mean of n=3). |
13
| Analytical |
|---|
| Specificity - |
| interference |
| from common |
| drugs, |
| Simvastatin, |
| Bezafibrate, |
| and Nicotinic |
| Acid, |
| Simvastatin, |
| Bezafibrate, |
| and Nicotinic |
| Acid (continued) |
The table below summarizes the common drug interferences data:
| Drug | Highest Concentration Shown Not to Interfere
with LDLC3 (drug concentrations in mg/L) |
|----------------------|------------------------------------------------------------------------------------------|
| Acetylcysteine | 553 |
| Ampicillin-Na | 1000 |
| Ascorbic acid | 5000 |
| Cyclosporine | 5 |
| Cefoxitin | 2500 |
| Heparin | 5000 U |
| Levodopa | 20 |
| Methyldopa +1.5 | 20 |
| Metronidazole | 200 |
| Phenylbutazone | 400 |
| Doxycyclin | 50 |
| Acetylsalicylic Acid | 1000 |
| Rifampicin | 60 |
| Acetaminophen | 200 |
| Ibuprofen | 500 |
| Theophylline | 100 |
Additional testing was done on Simvastatin, Bezafibrate, and Nicotinic Acid. The table below summarizes the interference data:
| Drug | Highest Concentration Shown Not to Interfere
with LDLC3 (drug concentrations in mg/L) |
|----------------|------------------------------------------------------------------------------------------|
| Simvastatin | 16 |
| Bezafibrate | 120 |
| Nicotinic Acid | 400 |
All data passed the following acceptance criteria: Difference in recovery to the reference sample: ≤± 10%
14
| Analytical
Specificity –
interference
from VLDL,
HDL,
Chylomicrons | The effects of interference by VLDL-cholesterol, HDL-cholesterol,
Chylomicrons on the LDLC3 test system was tested. |
|-----------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | HDL-cholesterol: Two sample pools, containing a low and high
concentration of LDL were used. These sample pools were divided into two
aliquots. One aliquot was not spiked with HDL and it was used as the
reference sample for LDL concentration. The LDL concentration in the
sample was determined with n = 3 measurements on a cobas c 501 analyzer. |
| | The other sample aliquot, with either the high or low LDL concentrations,
was spiked with the respective amount of HDL. The LDL concentration of
the spiked aliquots were determined in triplicate and the mean of the triplicate
determinations was compared to the LDL concentration determined for the
reference aliquot (mean of n=3). |
| | The mean of the triplicate determinations was compared to the LDL
concentration determined for the reference aliquot (mean of n=3). |
| | VLDL-cholesterol: VLDL were isolated from fresh human serum by
ultracentrifugation method. Two sample pools, containing a low and high
concentration of LDL were used. The samples were spiked with increasing
amounts of VLDL fraction with increasing amounts of VLDL concentrations. |
| | The sample pools were split into two aliquots. One aliquot was spiked with
VLDL-fraction the second was diluted with 0.9% NaCl as the reference. |
| | The mean of the duplicate determinations is compared to the LDL
concentration determined for the reference aliquot (mean of n=2). |
15
| Analytical
Specificity –
interference
from VLDL,
HDL,
Chylomicrons
(continued) | Chylomicrons (Triglycerides): Chylomicrons were separated from fresh
non-fasting human samples by centrifugation. Four sample pools**,
containing a low and high concentration of LDL were used. The samples
were spiked with increasing amounts of chylomicrons. Triglycerides
concentrations were measured in all samples. The sample pools were split
into two aliquots. One aliquot was spiked with chylomicrons the second was
diluted with 0.9% NaCl. The mean of the duplicate determinations was
compared to the LDL concentration determined for the reference aliquot
(mean of n=2). ** The four samples contain chylomicron concentrations ≥
2000 mg/dL Triglycerides. Additional samples with lower concentrations of
Chylomicron Triglycerides Data passed the following acceptance criteria: 3.87 mg/dL-549 mg/dL: ≤ ± 10%
Measuring range supported by Linearity Data (mg/dL)
| Plasma | Serum | |
|---|---|---|
| Range tested | 3.66 - 584 | 3.53 - 565 |
| Range found | 3.66 - 584 | 3.53 - 565 |
| Recommended measuring range | 3.87 - 549 | 3.87 - 549 |
Linear Regression Equation for Serum: y = 1.0171x - 0.3682
Linear Regression Equation for Plasma: y = 1x + 0 r2 = 0.9995
19
| Method
Comparison to
Predicate | A total of 100 human serum samples (including 5 spiked with human LDL
rich serum and 2 diluted with 0.9% NaCl, range of 4.99 - 534 mg/dL) were
tested in singlicate with the LDLC Gen2 assay and the LDLC3 reagent on
cobas c 501. |
|--------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Sample size (n) = 100 |
| | Passing/Bablok
y = 0.984x = 0.786 mg/dL
r = 0.999 |
| Conclusion | The submitted information in this premarket notification supports a
substantial equivalence decision. |