(182 days)
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No
The description focuses on chemical reaction methodology and standard performance metrics for a diagnostic reagent and calibrator system. There is no mention of AI, ML, or related concepts.
No
The device is described as a reagent and calibrator used for the quantitative determination of HDL cholesterol, which is a diagnostic measurement, not a therapeutic intervention.
Yes
The "Intended Use / Indications for Use" section explicitly states that "HDL cholesterol measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases, and for the assessment of the risk of developing cardiovascular disease." This indicates its role in identifying or confirming medical conditions.
No
The device description clearly states it is a "two-part reagent" and a "calibrator," which are physical components used in a chemical reaction. It also mentions being used with a "Chemistry System," implying hardware. This is not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states the quantitative determination of high density lipoprotein (HDL) cholesterol in serum and plasma. This is a measurement performed on biological samples in vitro (outside the body).
- Device Description: The description details a reagent and calibrator used with a chemistry system to perform a chemical reaction on the sample to measure HDL cholesterol. This is characteristic of an in vitro diagnostic test.
- Clinical Application: The intended use also mentions that the measurements are used in the diagnosis and treatment of various medical conditions and for assessing the risk of cardiovascular disease. This indicates a clinical purpose for the test results, which is a key aspect of IVDs.
- Sample Type: The device is intended for use with serum and plasma, which are biological specimens.
The information provided clearly aligns with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Envoy® 500 HDL Cholesterol Reagent and Calibrator are for the quantitative determination of high density lipoprotein (HDL) cholesterol in serum and plasma using the Envoy® 500 Chemistry System. HDL Cholesterol measurements are used in the diagnosis and treatment of lipid disorders mellitus), atherosclerosis, and various liver and renal diseases, and for the assessment of the risk of developing cardiovascular disease.
Product codes (comma separated list FDA assigned to the subject device)
LBS, JIT
Device Description
The Envoy® 500 HDL Cholesterol Reagent is a two-part reagent that is calibrated with the Envoy® 500 HDL Calibrator for use with the Envoy® 500 Chemistry System. This reagent determines high density lipoprotein cholesterol through the accelerator selective detergent methodology. This procedure measures HDL-cholesterol in a two step reaction sequence. In the first step, non-HDL cholesterol is rendered non-reactive. In the second step, HDL cholesterol is solubilized using a selective detergent and reacts to produce a red chromogen.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
adult patients
Intended User / Care Setting
This reagent is intended to be used by trained personnel in a professional setting and is not intended for home use.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Usable Range: The linear range of the Envoy 500 HDL Cholesterol Reagent is from 5 to at least 150 mg/dL, as shown by the recovery of linearity related solutions that span the linear range.
Limit of Detection: The limit of detection (LoD) for HDL cholesterol was determined based on CLSI protocol EP17-A. Forty blank samples and 40 low level samples were assayed. The Limit of Blank (LoB) is 0.29 mg/dL. The reported LoD is 0.46 mg/dL with proportions of false positives (a) less than 5% and false negatives (B) less than 5%.
Precision: Precision is demonstrated by the replicate assay of commercially available control sera.
Correlation: Mixed serum and plasma specimens, collected from adult patients, were assayed for HDL cholesterol using the Envoy 500 HDL cholesterol application and another commercially available method. Results were compared by least squares linear regression and Passing-Bablok regression.
Stability: The 14 day onboard reagent stability and 7 day calibration stability claims are documented through the assay of serum controls over the claimed periods. In all cases, statistical estimates of total imprecision are less than 1.5 mg/dL.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Usable Range: r = 0.9998, syx = 1.11 mg/dL, n = 44, range = 0.1 to 173.5 mg/dL
Limit of Detection: LoB is 0.29 mg/dL, LoD is 0.46 mg/dL
Precision:
Level 1: n = 45, mean = 36.8, Within Run SD = 0.52, Within Run %CV = 1.4%, Total SD = 0.72, Total %CV = 2.0%
Level 2: n = 48, mean = 71.1, Within Run SD = 0.68, Within Run %CV = 1.0%, Total SD = 1.25, Total %CV = 1.8%
Correlation - Least Squares Linear Regression: r = 0.995, S = 2.42 mg/dL, n = 312, range = 5 - 158 mg/dL, 95% CI y-intercept: 0.07 to 1.38 mg/dL, 95% CI slope: 1.010 to 1.032
Correlation - Passing - Bablok Regression: 95% CI y-intercept: 0.2 to 2.0 mg/dL, 95% CI slope: 1.000 to 1.029
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.
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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.
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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).
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§ 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.
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DEC 2 0 2007
Summary of 510(k) Safety and Effectiveness Information
Envoy® 500 HDL Cholesterol Reagent and Envoy® 500 HDL Calibrator
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
Submitted by:
| | Vital Diagnostics, Inc.
1075 West Lambert Road, Building D
Brea, California 92861 |
|-----------------------|-----------------------------------------------------------------------------------------------------------------|
| Contact Person: | Wynn Stocking
Regulatory Affairs Manager |
| Date Submitted: | December 4, 2007 |
| Device Names: | |
| Proprietary names: | Envoy® 500 HDL Cholesterol Reagent Kit, and
Envoy® 500 HDL Calibrator Kit |
| Common names: | High density lipoprotein (HDL) cholesterol reagent and
High density lipoprotein (HDL) cholesterol calibrator |
| Classification names: | LDL & VLDL precipitation, cholesterol via esterase-oxidase, HDL, and
Calibrator, primary |
Device Description:
The Envoy® 500 HDL Cholesterol Reagent is a two-part reagent that is calibrated with the Envoy® 500 HDL Calibrator for use with the Envoy® 500 Chemistry System. This reagent determines high density lipoprotein cholesterol through the accelerator selective detergent methodology. This procedure measures HDL-cholesterol in a two step reaction sequence. In the first step, non-HDL cholesterol is rendered non-reactive. In the second step, HDL cholesterol is solubilized using a selective detergent and reacts to produce a red chromogen.
Intended Use:
The Envoy® 500 HDL Cholesterol Reagent and Calibrator are for the quantitative determination of high density lipoprotein (HDL) cholesterol in serum and plasma using the Envoy® 500 Chemistry System. HDL Cholesterol measurements are used in the diagnosis and treatment of lipid disorders mellitus), atherosclerosis, and various liver and renal diseases, and for the assessment of the risk of developing cardiovascular disease.
Predicate Device:
The Envoy 500 HDL Cholesterol Reagent and Calibrator are substantially equivalent to the Genzyme Ultra N-geneous HDL Cholesterol Reagent, product nos. 80-6283-00 and 80-6277-00 and the Genzyme Ultra N-geneous HDL Cholesterol Calibrator, product no. 80-6449-00, which are currently marketed by Genzyme Corporation of Cambridge, MA.
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Summary of Performance Data:
The effectiveness of Envoy® 500 HDL Cholesterol Reagent and the Envoy® 500 HDL Calibrator for the Envoy® 500 Chemistry System is shown by the following studies.
Usable Range
The linear range of the Envoy 500 HDL Cholesterol Reagent is from 5 to at least 150 mg/dL, as shown by the recovery of linearity related solutions that span the linear range. Least squares regression statistics compare recoveries to the dilution factors of a set of reference pools prepared by diluting a human HDL cholesterol concentrate with stripped human serum pool.
(Envoy Recoveries) = - 0.6 mg/dL + 19.284 x (Dilution Factor), r = 0.9998, syx = 1.11 mg/dL, n = 44, range = 0.1 to 173.5 mg/dL
Limit of Detection
The limit of detection (LoD) for HDL cholesterol was determined based on CLSI protocol EP17-A. Forty blank samples and 40 low level samples were assayed. The Limit of Blank (LoB) is 0.29 mg/dL. The reported LoD is 0.46 mg/dL with proportions of false positives (a) less than 5% and false negatives (B) less than 5%.
Precision
Precision is demonstrated by the replicate assay of commercially available control sera. Precision statistics, calculated analogous to the method described in NCCLS Guideline EP3-T, are shown below.
| Sample | n | mean | Within Run | Total | ||
|---|---|---|---|---|---|---|
| I SD | %CV | 1 SD | %CV | |||
| Level 1 | 45 | 36.8 | 0.52 | 1.4% | 0.72 | 2.0% |
| Level 2 | 48 | 71.1 | 0.68 | 1.0% | 1.25 | 1.8% |
Correlation
Mixed serum and plasma specimens, collected from adult patients, were assayed for HDL cholesterol using the Envoy 500 HDL cholesterol application and another commercially available method. Results were compared by least squares linear regression and Passing-Bablok regression and the following statistics were obtained.
Least Squares Linear Regression
Envoy 500 = 0.7 mg/dL + 1.021 × Competitive Method r = 0.995 S = 2.42 mg/dL = 2.42 mg/dL = n = 312 = range = 5 - 158 mg/dL 95% CI y-intercept: 0.07 to 1.38 mg/dL 95% CI slope: 1.010 to 1.032
Passing - Bablok Regression
Envoy 500 = 0.7 mg/dL + 1.015 × Competitive Method 95% CI y-intercept: 0.2 to 2.0 mg/dL 95% CI slope: 1.000 to 1.029
Stability
The 14 day onboard reagent stability and 7 day calibration stability claims are documented through the assay of serum controls over the claimed periods. In all cases, statistical estimates of total imprecision are less than 1.5 mg/dL.
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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 and Human Services. The logo features a stylized depiction of an eagle or bird with three curved lines representing its wings or feathers. The bird is positioned to the right of the text, which is arranged in a circular pattern around the logo. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
DEC 2 0 2007
Clinical Data, Inc. c/o Mr. Wynn Stocking Manager, Regulatory Affairs 1075 West Lambert Road, Building D Brea. CA 92821
Re: K071706
Trade Name: Envoy® 500 HDL Cholesterol Reagent Kit and Envoy® 500 HDL Calibrator Regulation Number: 21 CFR 862.1475 Lipoprotein test system Regulation Name: Regulatory Class: Class I, subject to limitation to exemption in 21 CFR 862.9(c)(4) Product Code: LBS, JIT Dated: November 14, 2007 Received: November 15, 2007
Dear Mr. Stocking:
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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to logally marketed predicate device results in a classification for your device and thus, perroits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0490. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97), 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 (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Jean M. Cooper, M.S., D.V.M.
Jean M. Cooper, M.S., D.V.M. 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): K071706
Device Name: Envoy® 500 HDL Cholesterol Reagent and Envoy® 500 HDL Calibrator
Indication For Use:
The Envoy® 500 HDL Cholesterol Reagent and Envoy® 500 HDL Calibrator are intended for use with the Envoy® 500 Chemistry System as a system for the quantitative determination of high density lipoprotein (HDL) cholesterol in serum and plasma. HDL cholesterol measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases, and for the assessment of the risk of developing cardiovascular disease.
This reagent is intended to be used by trained personnel in a professional setting and is not intended for home use.
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 of Officer
Dision Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
$\underset{510(k)}{V}$ K071706