(105 days)
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No
The summary describes a standard in vitro diagnostic reagent and analyzer for measuring lactate dehydrogenase activity using a photometric method. There is no mention of AI, ML, image processing, or any data-driven algorithms beyond standard statistical analysis for performance evaluation.
No
This device is an in vitro diagnostic reagent used to measure lactate dehydrogenase activity in serum to aid in the diagnosis and treatment of certain diseases. It does not directly treat or prevent a disease.
Yes
The "Intended Use / Indications for Use" section explicitly states that "Lactate Dehydrogenase measurements are used in the diagnosis and treatment of liver diseases... cardiac diseases... and tumors..." and "This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only." This clearly indicates its purpose in providing information for diagnostic purposes.
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: The "Intended Use / Indications for Use" section explicitly states that the reagent is intended for the "quantitative determination of lactate dehydrogenase activity in serum" and that these measurements are "used in the diagnosis and treatment of liver diseases... cardiac diseases... and tumors...". This clearly indicates a diagnostic purpose.
- "For in vitro diagnostic use only": This phrase is explicitly stated in the Intended Use section, which is a common and definitive indicator of an IVD.
- Device Description: The description mentions it's for "quantitative in vitro diagnostic determination of LD activity in serum".
- Intended User / Care Setting: The intended users are "clinical laboratories or physician office laboratories," which are typical settings for IVD testing.
- Predicate Device: The mention of a "Predicate Device(s)" with a K number (K931786) is a strong indicator that this device is being submitted for regulatory clearance as an IVD, as predicate devices are used for comparison in the regulatory process for IVDs.
N/A
Intended Use / Indications for Use
Indications for use: The S-Test Lactate Dehydrogenase Reagent is intended for the quantitative determination of lactate dehydrogenase activity in serum using the S40 Clinical Analyzer. Lactate Dehydrogenase measurements are used in the diagnosis and treatment of liver diseases such as acute viral hepatitis, cirrhosis, and metastatic carcinoma of the liver, cardiac diseases such as myocardial infarction, and tumors of the lung or kidneys. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.
Product codes
CFJ
Device Description
The S-Test Lactate Dehydrogenase (LD) reagent cartridge, used with the S40 Clinical Analyzer, is intended for the quantitative in vitro diagnostic determination of LD activity in serum based on a photometric test measuring the rate of conversion of NADH from NAD in an enzyme assay. It is composed of a bi-reagent cartridge, and is intended for use in clinical laboratories or physician office laboratories.
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
Performance data on the S-Test LD included precision, accuracy, and detection limit data.
Precision: In testing conducted at three LD levels for 22 days, the within-run CV ranged from 1.5 to 2.4%, and total CV ranged from 6 to 7.1%. In precision studies at three separate Physician Office Laboratory (POL) sites and in-house over 5 days, the within-run CV ranged from 0.9 to 4.3% and total CV ranged from 0.9 to 5.1%.
Accuracy: In the correlation study, 81 samples with LD values ranging from 26 to 652 U/L were assayed on the S40 Clinical Analyzer using S-Test LD (y) and a comparative method (x). Least squares regression analysis yielded a correlation coefficient of 0.9857, a standard error estimate of 19.8, a confidence interval slope of 0.934 to 1.008, and a confidence interval intercept of -13.3 to 2.7. In patient correlation studies at four separate POL sites using the S40 Clinical Analyzer and a comparative method, least-squares regression analysis yielded correlation coefficients of 0.9971 to 0.9989, standard error estimates of 6.4 to 10.5, confidence interval slopes of 0.941 to 1.001, and a confidence interval intercepts of -11.1 to 11.0.
Detection limit: The detection limit was 9 U/L.
Key Metrics
Precision (within-run CV 1.5-2.4%, total CV 6-7.1%; POL within-run CV 0.9-4.3%, total CV 0.9-5.1%), Accuracy (correlation coefficient 0.9857 for 81 samples, 0.9971 to 0.9989 for POL studies), Detection Limit (9 U/L).
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.1440 Lactate dehydrogenase test system.
(a)
Identification. A lactate dehydrogenase test system is a device intended to measure the activity of the enzyme lactate dehydrogenase in serum. Lactate dehydrogenase measurements are used in the diagnosis and treatment of liver diseases such as acute viral hepatitis, cirrhosis, and metastatic carcinoma of the liver, cardiac diseases such as myocardial infarction, and tumors of the lung or kidneys.(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.
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SEY U 9 2009
ﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤ
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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 22, 2009 | |
| Device: | Trade Name: | S-Test LD Reagent cartridge |
| | Classification: | Class II Exempt |
| | Common/Classification Name: | Lactate Dehydrogenase Test
System
(21 C.F.R. § 862.1440)
Product Code CFJ |
| Predicate
Devices: | Manufacturer for analyzer/reagent system predicate:
Alfa Wassermann ACE plus ISE/Clinical Chemistry System
ACE Lactate Dehydrogenase Reagent (K931786) | |
| Device
Description: | The S-Test Lactate Dehydrogenase (LD) reagent cartridge, used with
the S40 Clinical Analyzer, is intended for the quantitative in vitro
diagnostic determination of LD activity in serum based on a
photometric test measuring the rate of conversion of NADH from NAD
in an enzyme assay. It is composed of a bi-reagent cartridge, and is
intended for use in clinical laboratories or physician office laboratories. | |
| Intended Use: | Indications for use: The S-Test Lactate Dehydrogenase Reagent is
intended for the quantitative determination of lactate dehydrogenase
activity in serum using the S40 Clinical Analyzer. Lactate
Dehydrogenase measurements are used in the diagnosis and treatment
of liver diseases such as acute viral hepatitis, cirrhosis, and metastatic
carcinoma of the liver, cardiac diseases such as myocardial infarction,
and tumors of the lung or kidneys. This test is intended for use in
clinical laboratories or physician office laboratories. For in vitro
diagnostic use only. | |
| Technological
Characteristics: | The S-Test LD Reagent is contained in a bi-reagent cartridge. Reagent 1 contains: Lithium L-lactate and diethanolamine buffer. Reagent 2
contains: Nicotinamide adenine dinucleotide. | |
| Performance
Data: | Performance data on the S-Test LD included precision, accuracy, and
detection limit data. | |
| | Precision: In testing conducted at three LD levels for 22 days, the
within-run CV ranged from 1.5 to 2.4%, and total CV ranged from 6
to 7.1%. In precision studies at three separate Physician Office
Laboratory (POL) sites and in-house over 5 days, the within-run CV
ranged from 0.9 to 4.3% and total CV ranged from 0.9 to 5.1%. | |
| | Accuracy: In the correlation study, 81 samples with LD values ranging
from 26 to 652 U/L were assayed on the S40 Clinical Analyzer using S-
Test LD (y) and a comparative method (x). Least squares regression
analysis yielded a correlation coefficient of 0.9857, a standard error
estimate of 19.8, a confidence interval slope of 0.934 to 1.008, and a
confidence interval intercept of -13.3 to 2.7. In patient correlation
studies at four separate POL sites using the S40 Clinical Analyzer and a
comparative method, least-squares regression analysis yielded
correlation coefficients of 0.9971 to 0.9989, standard error estimates of
6.4 to 10.5, confidence interval slopes of 0.941 to 1.001, and a
confidence interval intercepts of -11.1 to 11.0. | |
| | Detection limit: The detection limit was 9 U/L. | |
| Conclusions: | Based on the foregoing data, the device is safe and effective. These
data also indicate substantial equivalence to the predicate device. | |
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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 stylized eagle with three lines forming its body and wing, and a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA". The eagle is positioned to the right of the text, and the text is arranged around the circumference of the circle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Alfa Wassermann, Inc. c/o Dr. Hyman Katz 4 Henderson Drive West Caldwell, NJ 07006
SEP 0 9 2009
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002
Re: K091544
Trade/Device Name: S-Test Lactate Dehydrogenase (LD), Model RC 0017 Regulation Number: 21 CFR § 862.1440 Regulation Name: Lactate dehydrogenase test system Regulatory Class: Class II Product Code: CFJ Dated: July 7, 2009. Received: July 8, 2009
Dear Dr. Hyman 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 of medical devicerelated adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820).
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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/Resourcesfor You/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
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Indication for Use
510(k) Number (if known): K091544
Device Name: S-Test Lactate Dehydrogenase (LD)
Indication For Use:
The S-Test Lactate Dehydrogenase Reagent is intended for the quantitative determination of lactate dehydrogenase activity in serum using the S40 Clinical Analyzer. Lactate Dehydrogenase measurements are used in the diagnosis and treatment of liver diseases such as acute viral hepatitis, cirrhosis, and metastatic carcinoma of the liver, cardiac diseases such as myocardial infarction, and tumors of the lung or kidneys. 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) . And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OVD)
signature
Sign-Off Division Affice of In Vitro Diagnostic Device Evaluation and Safety
510(k) K091544