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.
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.

Device Description

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.

AI/ML Overview

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes acceptability based on substantial equivalence to an earlier version of the device, primarily focusing on the impact of a software upgrade that incorporates a humidity sensor. The acceptance criteria aren't explicitly stated as numerical targets in a table, but rather as demonstrating that the updated device performs equivalently to the predicate device, especially considering the correction factor applied for humidity.

The key performance aspect mentioned is that analytical results are unchanged when operated between 40% and 60% relative humidity, and that a small correction factor is applied for humidity levels between 20-40% RH and 60-80% RH. This implies that the device, after applying the correction, should produce results comparable to the predicate device across the specified humidity ranges.

Acceptance Criteria (Implied)	Reported Device Performance
Substantial equivalence to predicate device (v3.30 software).	Performance testing demonstrates that the software upgrade from revision v3.30 to v3.41 is substantially equivalent.
Analytical results unchanged at 40-60% Relative Humidity (RH).	Analytical results when the analyzer is operated between 40% and 60% relative humidity are unchanged and no correction factor is required.
Small correction factor applied for 20-40% RH and 60-80% RH.	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 (from a lookup table to the result from the assay algorithm). The analytical performance has been returned to its original intent (implying the correction maintains accuracy).
Intended Use and Indications for Use remain unchanged.	The Intended use is unchanged. The Indications for use is unchanged.
Manufacturing process remains unchanged.	The manufacturing process is unchanged.
Performance maintained despite humidity changes/corrections.	(Implied by "substantial equivalence" and "analytical performance has been returned to its original intent" after applying the correction factor.)

2. Sample Size Used for the Test Set and Data Provenance:

The document mentions "Performance testing demonstrates that the software upgrade..." but does not specify the sample size used for the test set.

Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. It is a submission to the FDA, suggesting a US-centric regulatory context, but detailed provenance is absent.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

This information is not provided in the document. The device is an in-vitro diagnostic system for quantitative determination of analytes (cholesterol, HDL, triglycerides, glucose), typically validated against reference methods rather than expert consensus on images or clinical assessments.

4. Adjudication Method for the Test Set:

This information is not provided. Given that this is an IVD device for quantitative measurements, adjudication in the sense of multiple experts reviewing results is unlikely to be the primary method for ground truth establishment. Instead, comparison against a reference method would be expected.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for imaging devices or AI tools where human readers interpret results, and the document describes an automated in-vitro diagnostic system.

6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

Yes, a standalone study was done. The "Performance testing" mentioned is specifically to demonstrate the performance of the device itself (analyzer + software + cassette), operating without human interpretation of the results to establish the primary measurements. The update specifically addresses the algorithm's behavior with the new humidity sensor and correction factor.

7. Type of Ground Truth Used:

The document does not explicitly state the type of ground truth used. However, for quantitative in-vitro diagnostic devices, the typical ground truth established in performance testing would involve:

Reference Methods: Comparison of the device's quantitative results against established, highly accurate laboratory reference methods (e.g., CDC-certified reference methods for lipids and glucose).
Traceability to Certified Standards: Ensuring the device's measurements are traceable to international or national certified reference materials and methods.

The phrase "analytical performance has been returned to its original intent" implies that the new software's results, especially after humidity correction, align with the performance previously validated against such reference methods.

8. Sample Size for the Training Set:

The document does not mention a training set in the context of machine learning or AI algorithm development. The change is described as a software revision that incorporates a humidity sensor and applies a correction factor from a "lookup table." This suggests a rule-based or empirically derived correction rather than a machine learning model that would require a distinct training set.

9. How the Ground Truth for the Training Set Was Established:

Since there is no mention of a training set in the context of machine learning, this information is not applicable and not provided. The "lookup table" for humidity correction would likely have been developed through internal testing and calibration processes, comparing device readings at various humidity levels against known, accurate values, but this is not explicitly detailed as a "training set" in the AI sense.

Summary

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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 RoadSan 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 · GLUCassetteAlere Cholestech LDX® Analyzer

Glucose:Class:Regulation number:Product Code:Panel:	II21 CFR 862.1345CGAClinical Chemistry
Lipids:Class:Regulation number:Product Code(s):Panel:	I (meets limitation for exemptionper 21 CFR 862.9(c)(4) and (9)21 CFR 862.1175, 862.1475, 862.1705CHH, LBS, JGYClinical Chemistry
Analyzer:Class:Regulation number:Product Code:Panel:	I (exempt)21 CFR 862.2160JJEClinical 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

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5.1. Intended Use / Indications for Use:

. 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.

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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.

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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

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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:

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

Regulation Number and Section

§ 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.