(441 days)
Not Found
No
The description focuses on quantitative determination and calculation of standard lipid and glucose values, with no mention of AI/ML terms or methodologies. The performance study summary only mentions a software upgrade for substantial equivalence, not related to AI/ML capabilities.
No.
The device is used for in vitro diagnostic testing to measure various substances in blood for diagnosis and treatment of disorders, not for therapeutic intervention.
Yes
The document states that the Alere Cholestech LDX® System is "for in vitro diagnostic use only" and that the measurements it provides are "used in the diagnosis and treatment of disorders."
No
The device description explicitly states it is a "small, portable analyzer and test cassette system," indicating the presence of hardware components in addition to any software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The document explicitly states multiple times that the system is "for in vitro diagnostic use only."
- Intended Use: The intended use describes the device as being used for the "quantitative determination" of various substances (cholesterol, HDL, triglycerides, glucose) in "whole blood." This is a classic description of an in vitro diagnostic test.
- Diagnostic Purpose: The intended use also clearly states that the measurements are "used in the diagnosis and treatment of disorders" related to lipid metabolism and carbohydrate metabolism. This directly aligns with the purpose of an IVD.
- Device Description: The device description reiterates that the system is "for in vitro diagnostic use only" and describes its function in determining substances in whole blood.
The information provided strongly indicates that the Alere Cholestech LDX® System is an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Alere Cholestech LDX® System is a small, portable analyzer and test cassette system is for in vitro diagnostic use only. The Lipid Profile GLU Cassette is for the quantitative determination of total cholesterol, HDL (high-density lipoprotein) cholesterol, triglycerides and glucose in whole blood. A TC/HDL (total cholesterol/HDL cholesterol ratio and estimated values for LDL (low-density lipoprotein) and non-HDL cholesterol are calculated by the Alere Cholestech LDX® Analyzer.
- . Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.
- . HDL (lipoprotein) measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.
- . Triglyceride measurements are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism, or various endocrine disorders.
- Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism . disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.
Product codes (comma separated list FDA assigned to the subject device)
CGA, CHH, LBS, JGY, JJE
Device Description
The Alere Cholestech LDX® System is a small, portable analyzer and test cassette system. The revision of the software is being changed from revision v3.41, which incorporates a humidity sensor as part of the ROM pack. This sensor measures the ambient humidity and applies a small correction factor from a lookup table to the result from the assay algorithm.
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
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing demonstrates that the software upgrade from revision v3.30 to v3.41 is substantially equivalent.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Not Found
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
§ 862.1345 Glucose test system.
(a)
Identification. A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.(b)
Classification. Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
0
5. 510(K) SUMMARY
510(k) number: ___ K120615
Date Prepared: 15 April 2013
| Submitter: | Alere San Diego, Inc. | Contact: | Edward Brehm |
|---|---|---|---|
| Address: | 9975 Summers Ridge Road | ||
| San Diego, CA 92121 | Regulatory Affairs Manager | ||
| Email: | ed.brehm@alere.com | ||
| Phone: | 858.805.3071 | Phone: | 858.805.3071 |
| Fax: | 858.695.7100 | Fax: | 858.695.7100 |
| Common Name (Device Type):
Alere Cholestech LDX® Lipid Profile · GLU
Cassette
| Alere Cholestech LDX® Analyzer |
|---|
| Glucose:
Class:
Regulation number:
Product Code:
Panel: | II
21 CFR 862.1345
CGA
Clinical Chemistry |
|-----------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|
| Lipids:
Class:
Regulation number:
Product Code(s):
Panel: | I (meets limitation for exemption
per 21 CFR 862.9(c)(4) and (9)
21 CFR 862.1175, 862.1475, 862.1705
CHH, LBS, JGY
Clinical Chemistry |
| Analyzer:
Class:
Regulation number:
Product Code:
Panel: | I (exempt)
21 CFR 862.2160
JJE
Clinical Chemistry |
| Original 510(k) Submissions: | Clearance Date: |
|---|---|
| K901900 – LDX Lipid Monitoring System | July 24, 1990 |
| K932727 – Lipid Profile•GLU Cassette | Nov 9, 1993 |
MAY 1 5 2013
1
5.1. Intended Use / Indications for Use:
The Alere Cholestech LDX® System is a small, portable analyzer and test cassette system is for in vitro diagnostic use only. The Lipid Profile GLU Cassette is for the quantitative determination of total cholesterol, HDL (high-density lipoprotein) cholesterol, triglycerides and glucose in whole blood. A TC/HDL (total cholesterol/HDL cholesterol ratio and estimated values for LDL (low-density lipoprotein) and non-HDL cholesterol are calculated by the Alere Cholestech LDX® Analyzer.
- . Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.
- . HDL (lipoprotein) measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.
- . Triglyceride measurements are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism, or various endocrine disorders.
- Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism . disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.
5.2. Summary of Changes:
The revision of the software is being changed from revision v3.41, which incorporates a humidity sensor as part of the ROM pack. This sensor measures the ambient humidity and applies a small correction factor from a lookup table to the result from the assay algorithm.
5.3. Substantial Equivalence:
Version v3.41 of the Alere Cholestech LDX® Analyzer ROM pack software is substantially equivalent to Alere Cholestech LDX® Analyzer ROM pack software version v3.30. The change is invisible to the user. Analytical results when the analyzer is operated between 40% and 60% relative humidity are unchanged and no correction factor is required. In more extreme cases, when the ambient humidity is between 20% RH and 40% RH, or between 60% RH and 80%RH, a small correction factor is applied.
5.4. List of Similarities:
The Intended use is unchanged The Indications for use is unchanged The analytical performance has been returned to its original intent The manufacturing process is unchanged
5.5. List of Differences:
Software version v3.41 contains a humidity sensor which measures the ambient humidity and applies a small correction factor to the analytical results based on a lookup table.
5.6. Conclusion:
Performance testing demonstrates that the software upgrade from revision v3.30 to v3.41 is substantially equivalent.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of the department's name arranged in a circular fashion around a symbol. The symbol is composed of three stylized, curved lines that appear to be interconnected. The text is in all caps and reads "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA".
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 15, 2013
Alere San Diego, Inc. C/O Edward Brehm, Ph.D. 9975 Summers Ridge Road SAN DIEGO CA 92121
Re: K120615
Trade/Device Name: Alere Cholestech LDX® Lipid Profile • GLU Cassette Alere Cholestech LDX® Analyzer
Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: CGA, CHH, LBS, JGY, JJE Dated: May 10, 2013 Received: May 13, 2013
Dear Dr. Brehm:
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 Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2—Dr. Brehm
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Carol C. Benson -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
4
Indications for Use
510(k) Number (if known): K120615
Device Name: Alere Cholestech LDX® Analyzer Alere Cholestech LDX® Lipid Profile●GLU Cassette
Intended Use / Indications for Use:
The Alere Cholestech LDX® System is a small, portable analyzer and test cassette system. The System is for in vitro diagnostic use only. The Lipid Profile GLU Cassette is for the quantitative determination of total cholesterol, HDL (high-density lipoprotein) cholesterol, triglycerides and glucose in whole blood. A TC/HDL (total cholesterol/HDL cholesterol ratio and estimated values for LDL (low-density lipoprotein) and non-HDL cholesterol are calculated by the Alere Cholestech LDX® Analyzer.
- Cholesterol measurements are used in the diagnosis and treatment of disorders . involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.
- HDL (lipoprotein) measurements are used in the diagnosis and treatment of lipid . disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.
- Triglyceride measurements are used in the diagnosis and treatment of patients with . diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism, or various endocrine disorders.
- Clucose measurements are used in the diagnosis and treatment of carbohydrate . metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.
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 Diagnostics and Radiological Health (OIR)
Ruth A. Chester S.
Division Sign-Off Office of In Vitro Diagnostics and Radiological Health
510(k) K120615