(53 days)
Not Found
No
The device description and performance studies focus on a chemical assay for LDL cholesterol, with no mention of AI or ML technologies.
No
This device is an in-vitro diagnostic reagent intended to measure LDL cholesterol in human serum, which is used for diagnosis, not treatment.
Yes
The device aids in the quantitative determination of low-density lipoprotein cholesterol (LDL-C) in human serum, and the measurement of LDL-C is a factor in the pathogenesis of atherosclerosis and coronary artery disease, which clearly indicates a diagnostic purpose.
No
The device description clearly outlines a chemical reagent and its interaction with serum samples, indicating a physical, non-software component. The performance studies also focus on chemical assay characteristics like precision and correlation with other chemical methods.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for the "quantitative determination of low density lipoprotein cholesterol in human serum." This involves testing a sample taken from the human body (serum) in vitro (outside the body) to provide diagnostic information (LDL cholesterol levels are a factor in atherosclerosis and coronary artery disease).
- Device Description: The description details a chemical reaction using reagents to analyze a serum sample and produce a result (color proportional to LDL cholesterol). This is a typical process for an in vitro diagnostic assay.
- Components: The device includes reagents, a calibrator, and controls, which are standard components of IVD kits used for quantitative measurements.
- Performance Studies: The performance studies describe testing the device's accuracy and precision against reference methods and other devices, which is a requirement for demonstrating the performance of an IVD.
- Predicate Device: The mention of predicate devices (other LDL cholesterol reagents, calibrators, and controls) further confirms its classification as an IVD, as predicate devices are used for comparison in the regulatory submission process for new IVDs.
All these elements align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
ACE® LDL-C Reagent is intended for use in the quantitative determination of low density lipoprotein cholesterol in human serum.
ACE® LDL-C Reagent is intended for the quantitative determination of LDL cholesterol in serum using the ACE® clinical chemistry system.
Product codes (comma separated list FDA assigned to the subject device)
MRR, JJX, JIS
Device Description
The ACE® LDL-C Reagent contains two reagents. An aliquot of serum is added to the first reagent, which contains a unique detergent that selectively solubilizes the non LDL lipoproteins. Enzymes also present in the first reagent consume the cholesterol in a non color forming reaction. The second reagent contains another detergent that releases the remaining LDL lipoproteins. The enzyme reaction with LDL cholesterol, in the presence of a chromogenic coupler, produces color that is directly proportional to the amount of LDL cholesterol in the sample.
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
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)
Non-clinical test results submitted in the premarket notification include within-run and between-run precision and method correlation.
Performance Summary:
Assay Range: 3 mg/dL to 800 mg/dL
Precision:
Within Run:
§ 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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JUL 13 1999
510(k) PREMARKET NOTIFICATION ACF® LDL-C Reagent
SUMMARY OF SAFETY AND EFFECTIVENESS
In lieu of a 510(k) statement under 513(i) of the Act, this Summary of Safety and Effectiveness is provided as a 510(k) summary for disclosure to any other persons/companies without specific written authorization from Schiapparelli Biosystems, Inc.
Submitter
Schiapparelli Biosystems, Inc. 368 Passaic Avenue Fairfield, NJ 07004 Phone: (973) 882-8630
Contact Person
Steven Dalessio Manager, Quality Assurance/Regulatory Affairs Phone: (973) 882-8630
Device Names
| Proprietary Name: | ACE® LDL-C Reagent
LDL-C Calibrator
LDL-C Controls |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Homogeneous assay for low density lipoprotein cholesterol |
| Classification Name: | Low density lipoprotein cholesterol test
Calibrator, Primary
Low density lipoprotein cholesterol control |
| Predicate Device: | Genzyme N-geneous® LDL Cholesterol Reagent
[510(k) Number K971573]
Genzyme N-geneous® LDL Cholesterol Calibrator
Genzyme LDL Control Set |
Device Description
The ACE® LDL-C Reagent contains two reagents. An aliquot of serum is added to the first reagent, which contains a unique detergent that selectively solubilizes the non LDL lipoproteins. Enzymes also present in the first reagent consume the cholesterol in a non color forming reaction. The second reagent contains another detergent that releases the remaining LDL lipoproteins. The enzyme reaction with LDL cholesterol, in the presence of a chromogenic coupler, produces color that is directly proportional to the amount of LDL cholesterol in the sample.
Intended Use of the Device
ACE® LDL-C Reagent is intended for use in the quantitative determination of low density lipoprotein cholesterol in human serum.
1
510(k) PREMARKET NOTIFICATION ACE® LDL-C Reagent
SUMMARY OF SAFETY AND EFFECTIVENESS
COMPARATIVE FEATURES OF PREDICATE AND PROPOSED DEVICES
| PARAMETER | PREDICATE DEVICE | PROPOSED DEVICE |
|---|---|---|
| Trade Name | Genzyme N-geneous® LDL Cholesterol | |
| Reagent | ACE® LDL-C Reagent | |
| Reference No. | K971573 | TBD |
| Analyte | LDL cholesterol | LDL cholesterol |
| Intended Use | Quantitative determination of | |
| LDL cholesterol | Quantitative determination of | |
| LDL cholesterol | ||
| Methodology | Homogeneous, Direct | Homogeneous, Direct |
| Reagents | ||
| Reagent 1 | ||
| Volume | Liquid; Detergent, Enzymes | |
| 300 µL | Liquid; Detergent, Enzymes | |
| 300 µL | ||
| Reagent 2 | ||
| Volume | Liquid; Detergent, Chromogenic coupler | |
| 100 µL | Liquid; Detergent, Chromogenic coupler | |
| 100 µL | ||
| Specimen | ||
| Type | ||
| Volume | Serum and plasma | |
| 3 µL | Serum | |
| 3 µL | ||
| Assay System | ||
| Reagent 1 + Sample | ||
| Reagent 2 | ||
| Temperature | Incubate 300 sec and Read | |
| Read at 300 sec | ||
| 37 °C | Incubate 300 sec and Read | |
| Read at 300 sec | ||
| 37 °C | ||
| Detection Method | ||
| Type | ||
| Wavelength, nm | Spectrophotometric | |
| Bichromatic: 546/660 | Spectrophotometric | |
| Bichromatic: 544/692 |
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510(k) PREMARKET NOTIFICATION ACE® LDL-C Reagent
SUMMARY OF SAFETY AND EFFECTIVENESS
PERFORMANCE ASSESSMENT
Non-clinical test results submitted in the premarket notification include within-run and between-run precision and method correlation. Following is a data summary.
| PARAMETER | PREDICATE DEVICE | PROPOSED DEVICE |
|---|---|---|
| Performance Summary | ||
| Assay Range | ||
| Precision | ||
| Within Run | ||
| Between Run | 6.6 mg/dL to 992 mg/dL | |
| ≤ 0.73 %CV | ||
| ≤ 2.27 %CV | 3 mg/dL to 800 mg/dL | |
| ≤ 2.6 %CV | ||
| ≤ 3.2 %CV | ||
| Correlation vs | Reference method (Ultracentrifugation) | Hitachi 911 |
| Slope | 0.95 | 1.111 |
| Intercept | +3.02 | -15.5 |
| r | 0.96 | 0.9747 |
| n | 54 | 70 |
| Correlation vs | Immunoseparation method | Friedewald calculation |
| Slope | 0.94 | 1.09 |
| Intercept | +4.46 | -17.8 |
| r | 0.97 | 0.9728 |
| n | 92 | 66 |
Based on these data, the Schiapparelli Biosystems ACE® LDL-C Reagent is substantially equivalent to the predicate device Genzyme N-geneous® LDL Cholesterol Reagent. On this basis, the reagent is determined to be safe and effective for its intended use. Performance details are included in the reagent product labeling.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around it. Inside the circle is an abstract symbol resembling a stylized caduceus or a representation of the human form.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUL 13 1999
Mr. Steven Dalessio Manager, Ouality Assurance/Regulatory Affairs Schiapparelli Biosystems, Inc. 368 Passaic Avenue Fairfield. New Jersey 07004
Re: K991733
Trade Name: ACE® LDL-C Reagent Regulatory Class: I reserved (Product codes: MRR, JJX) II (Product code: JIS) Dated: May 20, 1999 Received: May 21, 1999
Dear Mr. Dalessio:
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 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). 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 Regulations, 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 Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug 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 Register. 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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Page 2
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 (770) 488-7655.
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"(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 (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Steven Autman
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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Page 1 of
510(k) Number (if known): K991733
ACE® LDL-C Reagent Device Name:
Indications For Use:
ACE® LDL-C Reagent is intended for the quantitative determination of LDL cholesterol in serum using the ACE® clinical chemistry system.
LDL-C Calibrator is intended for the calibration of the ACE® LDL-C Assay.
LDL-C Controls are intended to monitor the performance of the ACE® LDL-C
Assav Assay.
The measurement of LDL cholesterol is a factor in the pathogenesis of
atherosclerosis and coronary artery disease atherosclerosis and coronary artery disease.
Jean looper
(Division Sign-Off) Division of Clinical Laboratory Devices 11,2 510(k) Number.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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OR
Over-The-Counter Use
(Optional Format 1-2-96)
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