(91 days)
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Not Found
No
The summary describes a chemical reagent kit for quantitative determination of HDL cholesterol, a standard laboratory assay. There is no mention of AI/ML in the device description, intended use, or performance studies.
No
The device is an in vitro diagnostic reagent used for quantitative determination of HDL cholesterol in human serum or plasma for diagnostic purposes, not for treating any condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that "Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders" and that the reagent is "For In Vitro Diagnostic Use." This indicates its purpose is to aid in diagnosis.
No
The device description clearly states it is a "two-reagent homogeneous method" and a "Kit," indicating it is a chemical reagent-based in vitro diagnostic device, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section clearly states: "For In Vitro Diagnostic Use."
- Nature of the Device: The device is a "Reagent" and "Calibrator" used for the "quantitative determination of high-density cholesterol lipoprotein cholesterol in human serum or plasma." This involves testing biological samples in vitro (outside the body).
- Purpose: The measurements are used in the "diagnosis and treatment of lipid disorders," which is a diagnostic purpose.
The device description further supports this by detailing a "two-reagent homogeneous method for the direct quantitative determination of high density lipoprotein cholesterol (HDL-C) in human serum and plasma," which is a typical description of an in vitro diagnostic assay.
N/A
Intended Use / Indications for Use
Reagent: For the quantitative determination of high-density cholesterol lipoprotein cholesterol in human serum or plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus, atherosclerosis and various liver and renal diseases). For In Vitro Diagnostic Use
Calibrator: For calibration of the Ultra HDL Cholesterol assay. For In Vitro Diagnostic Use
Product codes (comma separated list FDA assigned to the subject device)
LBS; JIS
Device Description
The new Ultra N-geneous® HDL Cholesterol Kit is a two-reagent homogeneous method for the direct quantitative determination of high density lipoprotein cholesterol (HDL-C) in human serum and plasma. The new Ultra N-geneous® HDL Cholesterol assay does not contain polyanion or divalent metal. "precipitation reagent". This new method is based on accelerating the reaction of cholesterol oxidase and dissolving HDL selectively using a specific detergent. The users use the reagent in the same manner as the current Liquid N-geneous® HDL Cholesterol Reagent.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
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Intended User / Care Setting
clinical and physician's office laboratory settings
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)
Comparative performance studies were conducted using the Ultra N-geneous® HDL Cholesterol Reagent compared to (1) the reference method: the Center for Disease Control (CDC) designated comparison method (DCM) and (2) the current Liquid N-geneous® HDL Cholesterol Reagent method (I). When samples contained triglyceride levels >400 mg/dL. the HDL reference method (ultracentrifuqation, chemical precipitation and Abell-Kendall) was performed.
One-hundred and one serum samples, with HDL values between 33.6 and 133.0 mg/dL, were tested at Genzyme Corporation using the Ultra N-geneous® HDL Reagent on the Hitachi 911 Analyzer, the predicate Liquid N-geneous® HDL Cholestero! Reagent method on the Hitachi 911 analyzer. Fiftytwo serum samples with HDL values between 32.0 -- 133.0 mg/dL were tested using the Ultra N-geneous® HDL Reagent on the Hitachi 911 Analyzer and at Pacific BioMetrics (Seattle, WA) using the Designated Comparison Method for samples with triglyceride levels ≤400 mg/dL.
Results of comparative studies:
vs. current Liquid N-geneous® HDL (n = 101):
Slope: 0.98
Intercept (mg/dL): 3.42
Correlation Coefficient (r): 0.996
Mean (mg/dL): 56.4
Standard Deviation (mg/dL): 13.6
Mean Difference (mg/dL): 2.3
Mean Percent Difference: 4.5
Range (m/gdL): 33.6 - 133.0
vs. Designated Comparison Method (n = 52):
Slope: 0.99
Intercept (mg/dL): 2.81
Correlation Coefficient (r): 0.996
Mean (mg/dL): 58.3
Standard Deviation (mg/dL): 15.5
Mean Difference (mg/dL): 2.0
Mean Percent Difference: 3.9
Range (m/gdL): 32.0 - 133.0
Precision studies were conducted using the Ultra N-geneous® HDL Cholesterol Test Kit. Both within-run and between-run studies were performed using frozen serum pools at three target levels of HDL cholesterol as determined by the National Cholesterol Education Program (NCEP):
§ 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.
0
Genzyme Corp rati n One Kendall Square Cambridge, MA 02139
JUL 2 5 2002
Ultra N-geneous® HDL Cholesterol R ag nt and Calibrator April 24, 2002
ATTACHMENT 1
K02/3/6
510(k) Summary Of Safety and Effectiveness Information Upon Which An Equivalence Determination Could be Made
| Trade or Proprietary Name: | Genzyme Ultra N-geneous® HDL Cholesterol Reagent
and Calibrator |
|----------------------------|----------------------------------------------------------------------------------------------------------------------------------|
| Common or Usual Name: | Homogeneous assay for high density lipoprotein
cholesterol |
| Classification Name: | High density lipoprotein cholesterol test |
| Manufacturer: | Genzyme Diagnostics
One Kendall Square
Cambridge, MA 02139-1562 |
| Contact Person: | Robert Yocher Vice President, Regulatory Affairs (617) 374-7275 or
Barbara Pizza, Manager Regulatory Associate (617) 252-7953 |
The use of the new Ultra Genzyme N-geneous® HDL Cholesterol in clinical and physician's office laboratory settings is substantially equivalent to the current Liquid N-geneous® HDL Cholesterol Reagent method (I). The new Ultra N-geneous® HDL Cholesterol Kit is a two-reagent homogeneous method for the direct quantitative determination of high density lipoprotein cholesterol (HDL-C) in human serum and plasma.
The new Ultra N-geneous® HDL Cholesterol assay does not contain polyanion or divalent metal. "precipitation reagent". This new method is based on accelerating the reaction of cholesterol oxidase and dissolving HDL selectively using a specific detergent. The users use the reagent in the same manner as the current Liquid N-geneous® HDL Cholesterol Reagent.
Comparative performance studies were conducted using the Ultra N-geneous® HDL Cholesterol Reagent compared to (1) the reference method: the Center for Disease Control (CDC) designated comparison method (DCM) and (2) the current Liquid N-geneous® HDL Cholesterol Reagent method (1). When samples contained triglyceride levels >400 mg/dL. the HDL reference method (ultracentrifuqation, chemical precipitation and Abell-Kendall) was performed.
One-hundred and one serum samples, with HDL values between 33.6 and 133.0 mg/dL, were tested at Genzyme Corporation using the Ultra N-geneous® HDL Reagent on the Hitachi 911 Analyzer, the predicate Liquid N-geneous® HDL Cholestero! Reagent method on the Hitachi 911 analyzer. Fiftytwo serum samples with HDL values between 32.0 -- 133.0 mg/dL were tested using the Ultra N-
1
geneous® HDL Reagent on the Hitachi 911 Analyzer and at Pacific BioMetrics (Seattle, WA) using the Designated Comparison Method for samples with triglyceride levels ≤400 mg/dL.
| | vs. current Liquid N-
geneous® HDL
(n = 101) | vs. Designated
Comparison Method
(n = 52) |
|-----------------------------|----------------------------------------------------|-------------------------------------------------|
| Slope | 0.98 | 0.99 |
| Intercept (mg/dL) | 3.42 | 2.81 |
| Correlation Coefficient (r) | 0.996 | 0.996 |
| Mean (mg/dL) | 56.4 | 58.3 |
| Standard Deviation (mg/dL) | 13.6 | 15.5 |
| Mean Difference (mg/dL) | 2.3 | 2.0 |
| Mean Percent Difference | 4.5 | 3.9 |
| Range (m/gdL) | 33.6 - 133.0 | 32.0 - 133.0 |
Precision studies were conducted using the Ultra N-geneous® HDL Cholesterol Test Kit. Both withinrun and between-run studies were performed using frozen serum pools at three target levels of HDL cholesterol as determined by the National Cholesterol Education Program (NCEP): Trade/Device Name: Ultra HDL Cholesterol Regulation Number: 21 CFR 862.1475 Regulation Name: Lipoprotein test system Regulatory Class: Class II Product Code: LBS; JIS Dated: July 8, 2002 Received: July 9, 2002
Dear Mr. Yocher:
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. Iisting 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 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
4
Page 2 -
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 (301) 594-4588. Additionally, for questions on the promotion and advertising of your device. please contact.the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmaldsmamain.html".
Sincerely yours,
Steven Butman
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
5
Genzyme Corporation One Kendall Square Cambridge, MA 02139
CONFIDENTIAL
Ultra N-geneous® HDL Cholesterol Reference No. K021316 July 8, 2002
. . . .
. . .
Page 1 of 1
510(k) NUMBER (if known): K021316
DEVICE NAME: _________________________________________________________________________________________________________________________________________________________________
INDICATIONS FOR USE:
Reagent:
For the quantitative determination of high-density cholesterol lipoprotein cholesterol in human serum or plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus, atherosclerosis and various liver and renal diseases).
For In Vitro Diagnostic Use
&
an Cooge
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K021316
Calibrator:
For calibration of the Ultra HDL Cholesterol assay. For In Vitro Diagnostic Use
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter-Use (Optional Format 1-2-96)