(89 days)
Not Found
No
The summary describes a reagent and analyzer for a photometric chemical reaction to measure LDL cholesterol. There is no mention of AI or ML in the device description, intended use, or performance studies.
No.
The device is an in vitro diagnostic reagent used to quantitatively determine LDL concentration, aiding in the diagnosis and treatment of lipid disorders but not directly providing therapy.
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 role in disease diagnosis.
No
The device is a reagent cartridge used with a clinical analyzer, which are physical components and not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: Explicitly states "For in vitro diagnostic use only." and describes the quantitative determination of LDL concentration in serum or heparin plasma for the diagnosis and treatment of lipid disorders, atherosclerosis, and various liver and renal diseases. This clearly indicates it's used to test samples taken from the body to provide information for diagnosis.
- Device Description: Describes the reagent cartridges as being "intended for quantitative in vitro diagnostic determination of LDL cholesterol concentrations in serum or heparin plasma".
- Intended User/Care Setting: Specifies use in "clinical laboratories or physician office laboratories," which are typical settings for IVD testing.
N/A
Intended Use / Indications for Use
The S-Test Low Density Lipoprotein Cholesterol Reagent is intended for the quantitative determination of LDL concentration in serum or heparin plasma using the S40 Clinical Analyzer. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.
Product codes
MRR
Device Description
The S-Test Low Density Lipoprotein (LDL) Cholesterol reagent cartridges, used with the S40 Clinical Analyzer, are intended for quantitative in vitro diagnostic determination of LDL cholesterol concentrations in serum or heparin plasma based on a photometric test measuring the formation of a reddish purple complex in a coupled enzymatic reaction.
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 laboratories or physician office laboratories.
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
Not Found
Summary of Performance Studies
Precision: In testing at three LDL levels for 22 days, the within-run CV ranged from 1.2 to 2.2%, and total CV ranged from 2.2 to 2.5%. In precision studies at three separate Physician Office Laboratory (POL) sites over 5 days, the within-run CV ranged from 0.8 to 2.8% and total CV ranged from 1.2 to 2.8%.
Accuracy: In a correlation study, 110 serum samples with LDL values ranging from 11 to 388 mg/dL were assayed on the S40 Clinical Analyzer using S-Test LDL (y) and a comparative method (x). Least-squares regression analysis yielded a correlation coefficient of 0.996, a standard error estimate of 6.6, a confidence interval slope of 0.948 to 0.982, and a confidence interval intercept of -1.7 to 3.4. In patient correlation studies at three separate POL sites using the S40 Clinical Analyzer and a comparative method, least-squares regression analysis yielded correlation coefficients of 0.995 to 0.997, standard error estimates of 6.0 to 8.0, confidence interval slopes of 0.895 to 0.967, and confidence interval intercepts of -4.6 to 13.6.
Sensitivity: The detection limit was 1 mg/dL.
Serum vs. Plasma: A study was performed by running LDL determinations on 34 paired samples drawn from the same patients in serum and lithium heparin plasma tubes. The use of plasma was confirmed in a matrix comparison study using the paired t-test for means: Range: 13 to 350 mg/dL (serum), t-Statistic = 1.71, t-Critical value 2.03 at a = 0.05, not statistically significant.
Key Metrics
Precision: Within-run CV ranged from 1.2 to 2.2%, total CV ranged from 2.2 to 2.5%. POL sites: within-run CV ranged from 0.8 to 2.8%, total CV ranged from 1.2 to 2.8%.
Accuracy: Correlation coefficient of 0.996, standard error estimate of 6.6, confidence interval slope of 0.948 to 0.982, confidence interval intercept of -1.7 to 3.4. POL sites: correlation coefficients of 0.995 to 0.997, standard error estimates of 6.0 to 8.0, confidence interval slopes of 0.895 to 0.967, and confidence interval intercepts of -4.6 to 13.6.
Sensitivity: Detection limit was 1 mg/dL.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
AUG Ó 3 2009
Attachment 2 – 510(k) Summary
510(k) SUMMARY
| 510(k) Owner: | Alfa Wassermann Diagnostic Technologies, LLC
4 Henderson Drive
West Caldwell, NJ 07006 | |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|
| Contact: | Hyman Katz, Ph.D.
Phone: 973-852-0158
Fax: 973-852-0237 | |
| Date Summary
Prepared: | May 5, 2009 | |
| Device: | Trade Name: | S-Test LDL Reagent cartridge |
| | Classification: | Class I Exempt |
| | Common/Classification Name: | Low Density Lipoprotein Cholesterol Test
System
(21 C.F.R. § 862.1475)
Product Code MRR |
| Predicate
Devices: | Manufacturer for analyzer/reagent system predicate:
Alfa Wassermann ACE plus ISE/Clinical Chemistry System
ACE Low Density Lipoprotein Cholesterol Reagent (K991733) | |
| Device
Description: | The S-Test Low Density Lipoprotein (LDL) Cholesterol reagent cartridges,
used with the S40 Clinical Analyzer, are intended for quantitative in vitro
diagnostic determination of LDL cholesterol concentrations in serum or
heparin plasma based on a photometric test measuring the formation of a
reddish purple complex in a coupled enzymatic reaction. | |
| Intended Use: | The S-Test Low Density Lipoprotein Cholesterol Reagent is intended for the
quantitative determination of LDL concentration in serum or heparin plasma
using the S40 Clinical Analyzer. Lipoprotein measurements are used in the
diagnosis and treatment of lipid disorders (such as diabetes mellitus),
atherosclerosis, and various liver and renal diseases. This test is intended for
use in clinical laboratories or physician office laboratories. For in vitro
diagnostic use only. | |
| Technological
Characteristics: | The S-Test LDL Reagent is contained in a bi-reagent cartridge. Reagent 1
contains 4-aminoantipyrine, cholesterol esterase, cholesterol oxidase,
peroxidase, and a surfactant in Good's buffer. Reagent 2 contains a different
surfactant, N,N-bis (4-sulfobutyl)-m-toluidine, disodium salt in Good's buffer. | |
| Performance
Data: | Performance data on the S-Test LDL reagent included precision, accuracy,
sensitivity data and matrix comparison data. | |
| | Precision: In testing at three LDL levels for 22 days, the within-run CV
ranged from 1.2 to 2.2%, and total CV ranged from 2.2 to 2.5%. In precision
studies at three separate Physician Office Laboratory (POL) sites over 5 days,
the within-run CV ranged from 0.8 to 2.8% and total CV ranged from 1.2 to
2.8%. | |
| | Accuracy: In a correlation study, 110 serum samples with LDL values ranging
from 11 to 388 mg/dL were assayed on the S40 Clinical Analyzer using S-
Test LDL (y) and a comparative method (x). Least-squares regression analysis
yielded a correlation coefficient of 0.996, a standard error estimate of 6.6, a
confidence interval slope of 0.948 to 0.982, and a confidence interval intercept
of -1.7 to 3.4. In patient correlation studies at three separate POL sites using
the S40 Clinical Analyzer and a comparative method, least-squares regression
analysis yielded correlation coefficients of 0.995 to 0.997, standard error
estimates of 6.0 to 8.0, confidence interval slopes of 0.895 to 0.967, and
confidence interval intercepts of -4.6 to 13.6. | |
| | Sensitivity: The detection limit was 1 mg/dL. | |
| | Serum vs. Plasma: A study was performed by running LDL determinations on
34 paired samples drawn from the same patients in serum and lithium heparin
plasma tubes. The use of plasma was confirmed in a matrix comparison study
using the paired t-test for means: Range: 13 to 350 mg/dL (serum), t-Statistic
= 1.71, t-Critical value 2.03 at a = 0.05, not statistically significant. | |
| Conclusions: | Based on the foregoing data, the device is safe and effective. These data also
indicate substantial equivalence to the predicate device. | |
·
1
・
and the same of the same of the same of the same of
and the comments of the comments of the comments of the comments of
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized wing shapes.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993
Alfa Wasserman, Inc. c/o Mr. Hyman Katz Vice President, Quality & Regulatory Affairs 4 Henderson Drive West Caldwell, NJ 07006
AUG 0 3 2009
Re: K091333
Trade Name: S-Test LDL Cholesterol (LDL) Regulation Number: 21 CFR $862.1475 Regulation Name: Lipoprotein test system. Regulatory Class: Class I Product Codes: MRR Dated: May 5, 2009 Received: May 6, 2009
Dear Mr. Katz:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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); and good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820).
3
Page 2
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or ( 301 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
G.C.H
Courtney C. Harper, Ph.D. Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
4
Indication for Use
510(k) Number (if known): K091333
Device Name:
S-Test Low Density Lipoprotein (LDL) Cholesterol
Indication For Use:
The S-Test Low Density Lipoprotein Cholesterol Reagent is intended for the quantitative determination of LDL concentration in serum or heparin plasma using the S40 Clinical Analyzer. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.
Prescription Use X (21 CFR Part 801 Subpart D) Over the Counter Use -(21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
And/Or
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K091333