What is the FDA product code for ENVOY 500 HDL; CHOLESTEROL REAGENT KIT (MODEL# 55301), CALIBRATOR KIT (MODEL# 55118)?

LBS. It is classified under 21 CFR 862.1475 as a Class 1 device in the Clinical Chemistry panel.

What is the regulatory pathway for ENVOY 500 HDL; CHOLESTEROL REAGENT KIT (MODEL# 55301), CALIBRATOR KIT (MODEL# 55118)?

510(k) clearance (submission type: Traditional).

What are the predicate devices for ENVOY 500 HDL; CHOLESTEROL REAGENT KIT (MODEL# 55301), CALIBRATOR KIT (MODEL# 55118)?

Genzyme Ultra N-geneous HDL Cholesterol Reagent and Genzyme Ultra N-geneous HDL Cholesterol Calibrator (k021316).

Who can help prepare an FDA 510(k) submission like ENVOY 500 HDL; CHOLESTEROL REAGENT KIT (MODEL# 55301), CALIBRATOR KIT (MODEL# 55118)?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

ENVOY 500 HDL; CHOLESTEROL REAGENT KIT (MODEL# 55301), CALIBRATOR KIT (MODEL# 55118)

Q: Who is the manufacturer of ENVOY 500 HDL; CHOLESTEROL REAGENT KIT (MODEL# 55301), CALIBRATOR KIT (MODEL# 55118)?

Clinical Data, Inc. filed the 510(k) submission for ENVOY 500 HDL; CHOLESTEROL REAGENT KIT (MODEL# 55301), CALIBRATOR KIT (MODEL# 55118) (K071706).

K071706 · Clinical Data, Inc. · LBS · Dec 20, 2007 · Clinical Chemistry

Device Facts

Record ID	K071706
Device Name	ENVOY 500 HDL; CHOLESTEROL REAGENT KIT (MODEL# 55301), CALIBRATOR KIT (MODEL# 55118)
Applicant	Clinical Data, Inc.
Product Code	LBS · Clinical Chemistry
Decision Date	Dec 20, 2007
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 862.1475
Device Class	Class 1

Intended 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.

Device Story

Envoy 500 HDL Cholesterol Reagent is a two-part reagent kit used with the Envoy 500 Chemistry System; utilizes accelerator selective detergent methodology. Process: first step renders non-HDL cholesterol non-reactive; second step solubilizes HDL cholesterol using selective detergent to produce red chromogen. System measures absorbance to quantify HDL-cholesterol concentration. Used in clinical laboratory settings by trained personnel. Output provides quantitative HDL-cholesterol values; assists clinicians in diagnosing lipid disorders, atherosclerosis, liver/renal disease, and assessing cardiovascular risk. Benefits patient through accurate lipid profile monitoring.

Clinical Evidence

No clinical data. Performance established via bench testing. Precision: within-run CV 1.0-1.4%, total CV 1.8-2.0%. Linearity: 5-150 mg/dL (r=0.9998). Method comparison: 312 samples (serum/plasma) compared to predicate (y = 0.7 + 1.021x, r=0.991). Analytical specificity tested against ascorbic acid, bilirubin, hemoglobin, and triglycerides.

Technological Characteristics

Two-part reagent kit; accelerator selective detergent methodology. Energy source: photometric detection via Envoy 500 Chemistry System. Connectivity: integrated with Envoy 500 system. Sterilization: N/A (reagent). Software: embedded firmware for system control and calculation.

Indications for Use

Indicated for quantitative determination of HDL cholesterol in serum and plasma for adult patients to diagnose/treat lipid disorders, atherosclerosis, liver/renal diseases, and assess cardiovascular risk.

Regulatory Classification

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.

Predicate Devices

Genzyme Ultra N-geneous HDL Cholesterol Reagent and Genzyme Ultra N-geneous HDL Cholesterol Calibrator (k021316)

Related Devices

K032932 — DIRECT HDL-CHOLESTEROL LIQUID COLOR; DIRECT HDL/LDL-CHOLESTEROL CALIBRATOR · Stanbio Laboratory · Mar 10, 2004
K073497 — HDL CHOLESTEROL REAGENT, MODEL 10211 · Medica Corp. · Apr 14, 2008

Submission Summary (Full Text)

{0}------------------------------------------------ # 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. {1}------------------------------------------------ #### 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. {2}------------------------------------------------ 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). {3}------------------------------------------------ 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 {4}------------------------------------------------ # 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