RAICHEM HDL-CHOLESTEROL DIRECT REAGENT, HDL-CHOLESTEROL CALIBRATOR

• K Number: K982767
• Device Name: RAICHEM HDL-CHOLESTEROL DIRECT REAGENT, HDL-CHOLESTEROL CALIBRATOR
• Manufacturer: RAICHEM
• Date Cleared: 1998-09-21 ( 46 days)
• Product Code: JIX LBS
• Regulation Number: 862.1150

Intended Use

The Raichem HDL-Cholesterol Direct Reagent is intended for the quantitative determination of HDL-Cholesterol in serum or plasma. The Raichem HDL-Cholesterol Calibrator is intended to be used for the calibration of the Raichem HDL-Cholesterol Direct assay.

Device Description

The Raichem HDL-Cholesterol Direct test is based upon two sets of reaction sequences. In the first set of reactions Chylomicrons. VLDL selectively react with cholesterol esterase and are then eliminated from the reaction scheme. The addition of the second reagent causes the reaction of HDL-Cholesterol with cholesterol esterase and the subsequent production of color. The resultant increase in absorbance is directly proportional to the concentration of HDL-Cholesterol in the sample. The Raichem HDL-Cholesterol Calibrator is a serum calibrator used for the calibration of the Raichem HDL-Cholesterol Direct assay.

Predicate Devices

K830207A, K963213

Reference Devices

K830207A, K963213

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on chemical reactions and standard statistical analysis, with no mention of AI or ML terms or concepts.

Therapeutic

No
The device is described as a reagent for the quantitative determination of HDL-Cholesterol in serum or plasma, which is a diagnostic function, not a therapeutic one.

Diagnostic

Yes
The device is described as "intended for the quantitative determination of HDL-Cholesterol in serum or plasma," which directly relates to diagnosing or monitoring a health condition.

SaMD (Software as a Medical Device)

No

The device description clearly outlines a chemical reagent and calibrator used for a laboratory assay, which are physical components, not software.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use explicitly states "quantitative determination of HDL-Cholesterol in serum or plasma." Serum and plasma are biological specimens taken from the human body.
• Device Description: The description details a chemical reaction that occurs with the sample (serum or plasma) to produce a measurable result (color change and absorbance). This is characteristic of in vitro diagnostic tests.
• Performance Studies: The performance studies describe testing performed on "sample pairs" and "results (mg/dL)," indicating measurements taken from biological samples.
• Predicate Devices: The predicate devices listed are also HDL-Cholesterol reagents and calibrators, which are typically IVDs used in clinical laboratories.

The core function of the device is to analyze a biological sample in vitro (outside the body) to provide diagnostic information (the concentration of HDL-Cholesterol). This aligns perfectly with the definition of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Raichem HDL-Cholesterol Direct Reagent is intended for the quantitative determination of HDL-Cholesterol in serum or plasma. The Raichem HDL-Cholesterol Calibrator is intended to be used for the calibration of the Raichem HDL-Cholesterol Direct assay.

Product codes

LBS, JIS, JIX

Device Description

The Raichem HDL-Cholesterol Direct test is based upon two sets of reaction sequences. In the first set of reactions Chylomicrons. VLDL selectively react with cholesterol esterase and are then eliminated from the reaction scheme. The addition of the second reagent causes the reaction of HDL-Cholesterol with cholesterol esterase and the subsequent production of color. The resultant increase in absorbance is directly proportional to the concentration of HDL-Cholesterol in the sample. The Raichem HDL-Cholesterol Calibrator is a serum calibrator used for the calibration of the Raichem HDL-Cholesterol Direct assay.

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

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Description of the test set, sample size, data source, and annotation protocol

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Summary of Performance Studies

Precision studies were performed in 48 runs over a period of 24 days following the NCCLS EP5-T2 Tentative Guideline.
The lower detection limit for the proposed device was determined to be 1 mg/dL.
Linearity: 1 to 150 mg/dL.
Comparison of Raichem HDL-Cholesterol Direct Reagent (y) with the CDC HDL-Cholesterol designated comparison method (x). Testing was performed in accordance with NCCLS EP9-A Approved Guideline. The Raichem HDL-Cholesterol Direct assay was performed using the Raichem Serum Calibrator (Ortho Automated Reference Serum) on the Hitachi 717. Number of sample pairs (n): 47, Range of results (mg/dL): 24 – 70, Correlation Coefficient: 0.987, Regression Equation: y = 0.9488x + 2.0.
Comparison of Raichem HDL-Cholesterol Direct Reagent (y) with Raichem HDL-Cholesterol Reagent (500,000 MW dextran sulfate) (x), following the NCCLS EP9-A Approved Guideline. Number of sample pairs (n): 48, Range of results (mg/dL): 23.0 - 77.1, Correlation Coefficient: 0.988, Regression Equation: y = 1.011x + 0.192.

Key Metrics

Precision (Mean (mg/dL), SD, CV %):
33.1, 0.89, 2.7 (Total)
33.1, 0.26, 0.8 (Within Run)
51.21, 1.35, 2.6 (Total)
51.21, 0.32, 0.6 (Within Run)

Lower Detection Limit: 1 mg/dL

Correlation Coefficient: 0.987 (comparing to CDC method), 0.988 (comparing to Raichem HDL-Cholesterol Reagent)

Predicate Device(s)

K830207A, K963213

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 862.1150 Calibrator.

(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(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 the limitations in § 862.9.

Summary

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510(k) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is:

1. Submitter's Name/Contact Person

Melissa Saner/Technical Marketing Manager

Address

Raichem Division of Hemagen Diagnostics, Inc. # 2022395 Formerly: Reagents Applications, Inc. 8225 Mercury Court San Diego, CA 92129 Phone: [phone] extension 111 Fax: [phone] Email: [e-mail]

Date Prepared

August 4, 1998

2. Device Name

Trade Name:	Raichem HDL-Cholesterol Direct Reagent
Common Name:	High density (HDL) cholesterol test
Classification Name:	Lipoprotein test system
Device Classification:	I
Regulation Number:	21 CFR 862.1475
Panel:	Chemistry (75)
Product Code:	LBS
Trade Name:	HDL-Cholesterol Calibrator
Common Name:	HDL-Cholesterol Calibrator
Classification Name:	Calibrator, Primary
Device Classification:	II
Regulation Number:	21 CFR 862.1150
Panel:	Chemistry (75)
Product Code:	JIS

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3. Predicate Device

CDC Designated Comparison Method: Cholesterol Reference Method Laboratory Network

Raichem HDL-Cholesterol Reagent: 510(k) Docket No. K830207A Boehringer Mannheim Direct HDL-Cholesterol: 510(k) Docket No. K963213 Boehringer Mannheim C.f.a.s. HDL-C (Calibrator); 510(k) Docket No. K963213 Raichem Serum Calibrator (Ortho Automated Reference Serum Assayed -Marketed by Chiron Diagnostics): No 510(k) Docket Number Assigned (Pre Medical Device Amendments of 1976) (Medical Device Listing Document No. A 268140)

4. Description of Device

The Raichem HDL-Cholesterol Direct test is based upon two sets of reaction sequences. In the first set of reactions Chylomicrons. VLDL selectively react with cholesterol esterase and are then eliminated from the reaction scheme. The addition of the second reagent causes the reaction of HDL-Cholesterol with cholesterol esterase and the subsequent production of color. The resultant increase in absorbance is directly proportional to the concentration of HDL-Cholesterol in the sample. The Raichem HDL-Cholesterol Calibrator is a serum calibrator used for the calibration of the Raichem HDL-Cholesterol Direct assay.

5. Intended Use of Device

The Raichem HDL-Cholesterol Direct Reagent is intended for the quantitative determination of HDL-Cholesterol in serum or plasma. The Raichem HDL-Cholesterol Calibrator is intended to be used for the calibration of the Raichem HDL-Cholesterol Direct assay.

6. Substantial Equivalence

A. Technological Characteristics

Proposed Device

• The Raichem HDL-Cholesterol Reagent involves the direct selective reaction of HDL-1. Cholesterol utilizing surfactants and MgCl2 in a specific buffered environment.
• 2. The Raichem HDL-Cholesterol Calibrator is a serum calibrator used for the calibration of the Raichem HDL-Cholesterol Direct assay.

Predicate Device

• 1. The Designated Comparison Method is performed by a laboratory that is part of the Cholesterol Reference Method Laboratory Network. This method is standardized to the CDC reference method for HDL-Cholesterol.
• 2. The Raichem HDL-Cholesterol Reagent involves the precipitation of VLDL and LDL utilizing dextran sulfate (500,000 MW) and magnesium sulfate.
• ന് The Boehringer Mannheim Direct HDL-Cholesterol is a homogenous assay involving the selective reaction of HDL-Cholesterol utilizing PEG and sulfated cyclodextrin.
• 4. The Raichem Serum Calibrator (Ortho Automated Reference Serum) is a device purchased from Chiron Diagnostics by Raichem. This device is a serum calibrator used for the calibration of clinical chemistry assays.

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Page 3 510(k) Summary HDL-Cholesterol Direct

B. Performance Data

Precision

Precision studies were performed in 48 runs over a period of 24 days following the NCCLS EP5-T2 Tentative Guideline.

	Total		Within Run
Mean (mg/dL)	SD	CV %	SD	CV %
33.1	0.89	2.7	0.26	0.8
51.21	1.35	2.6	0.32	0.6

Standardization of the Calibrator

The value for the calibrator is established by ultracentrifugation. It is traceable to the National Institute of Standards Standard Reference Material (1951a). The procedures used to assign the value to this calibrator material meet the requirements of the "HDL Cholesterol Method Evaluation Protocol for Manufacturers" of the U.S. National Reference System for Cholesterol, CRMLN (Cholesterol Reference Method Laboratory Network), August 1995.

Lower Detection Limit

The lower detection limit for the proposed device was determined to be 1 mg/dL.

Linearity

1 to 150 mg/dL

Comparison Testing

• Comparison of Raichem HDL-Cholesterol Direct Reagent (y) with the CDC HDL-1. Cholesterol designated comparison method (x). Testing was performed in accordance with NCCLS EP9-A Approved Guideline. The Raichem HDL-Cholesterol Direct assay was performed using the Raichem Serum Calibrator (Ortho Automated Reference Serum) on the Hitachi 717.

Number of sample pairs (n):	47
Range of results (mg/dL):	24 – 70
Correlation Coefficient:	0.987
Regression Equation:	$y = 0.9488x + 2.0$

• 2. Comparison of Raichem HDL-Cholesterol Direct Reagent (y) with Raichem HDL-Cholesterol Reagent (500,000 MW dextran sulfate) (x), following the NCCLS EP9-A Approved Guideline.

Number of sample pairs (n):	48
Range of results (mg/dL):	23.0 - 77.1
Correlation Coefficient:	0.988
Regression Equation:	$y = 1.011x + 0.192$

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SEP 2 1 1998

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Melissa Saner Technical Marketing Manager Raichem 8225 Mercury Court San Diego, California 92111-1203

K982767 Re : HDL-Cholesterol Direct Reagent and Calibrator Regulatory Class: I & II Product Code: JIX, LBS Dated: August 4, 1998 Received: August 6, 1998

Dear Ms. Saner:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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, Druq, and Cosmetic Act (Act). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact
the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.qov/cdrh/dsmamain.html".

Sincerely yours,
Steven Bitman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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HDL-Cholesterol Calibrator Device Name:

Indication(s) For Use

This calibrator is intended to be used for the calibration of the Raichem HDL-Cholesterol Direct assay.

HDL-Cholesterol Direct Reagent Device Name:

Indication(s) For Use

This reagent is intended to be used for the quantitative determination of HDL-Cholesterol in human serum or plasma.

(PLEASE DO NOT WRITE BELOW THIS LINE)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter-Use_

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K982767