(23 days)
Not Found
No
The device description details a chemical assay for measuring HDL cholesterol, and there is no mention of AI or ML in the provided text.
No.
This device is an in vitro diagnostic product intended for the quantitative determination of HDL cholesterol in human serum, which is used for diagnosis, not treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states, "This in vitro diagnostic product is intended for the quantitative determination of HDL cholesterol in human serum." The term "in vitro diagnostic product" directly indicates it is a diagnostic device.
No
The device description clearly outlines a chemical assay involving reagents and serum, indicating a hardware component (likely a laboratory analyzer) is required for its function, not just software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "This in vitro diagnostic product is intended for the quantitative determination of HDL cholesterol in human serum."
This statement clearly identifies the device as an in vitro diagnostic product.
N/A
Intended Use / Indications for Use
ACE™ HDL-C Reagent is intended for use in the quantitative determination of HDL cholesterol in human serum.
This in vitro diagnostic product is intended for the quantitative determination of HDL cholesterol in human serum.
Product codes (comma separated list FDA assigned to the subject device)
LBS, JIX, JJY
Device Description
An aliquot of serum is added to the first reagent which contains a mixture of polymers and polyanions that bind to the surface of low-density lipoproteins (LDL), very low-density lipoproteins (VLDL) and chylomicrons. These complexed lipoproteins are stabilized, even in the presence of detergent, which is added as part of the second reagent, together with cholesterol enzymes. HDL particles are not stabilized by the polymers and polyanions and become solubilized by the detergent. As a result, only the HDL cholesterol is subject to measurement.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Assay Range: 2 mg/dL to 100 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.
0
510(k) PREMARKET NOTIFICATION Summary of Safety and Effectiveness ACE™ HDL-C Reagent
In lieu of a 510(k) statement under 513(i) of the Act, this Summary of Safety and Effectiveness is tur nou of a S10(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: (201) 882-8630
Contact Person
Steve Dalessio Manager. Quality Assurance and Regulatory Affairs Phone: (201) 882-8630
Device Names
ACE™ HDL-C Reagent Proprietary Name: Homogeneous assay for high density lipoprotein cholesterol Common Name: Classification Name: High density lipoprotein cholesterol test
Predicate Device
Genzyme Corporation's - N-geneous™ HDL Cholesterol Reagent [510(k) Number K962186]
Device Description
An aliquot of serum is added to the first reagent which contains a mixture of polymers and polyanions that bind to the surface of low-density lipoproteins (LDL), very low-density lipoproteins (VLDL) and chylomicrons. These complexed lipoproteins are stabilized, even in the presence of detergent, which is added as part of the second reagent, together with cholesterol enzymes. HDL particles are not stabilized by the polymers and polyanions and become solubilized by the detergent. As a result, only the HDL cholesterol is subject to measurement.
Intended Use of the Device
ACE™ HDL-C Reagent is intended for use in the quantitative determination of HDL cholesterol in human serum.
HHDL510K.WPS
Image /page/0/Picture/17 description: The image shows the date May 21, 1997. The month is written in all caps, and the day and year are written in numerals. The text is written in a bold, sans-serif font. The image is a close-up of the date, and the background is white.
1
Summary of Safety and Effectiveness ACE™ HDL-C Reagent
COMPARATIVE FEATURES OF PREDICATE AND PROPOSED DEVICE
| PARAMETER | PREDICATE DEVICE | PROPOSED DEVICE |
|---|---|---|
| Trade Name | N-geneous TM HDL | |
| Cholesterol | ACE TM HDL-C Reagent | |
| Reference No. | K962186 | TBD |
| Analyte | HDL Cholesterol | HDL Cholesterol |
| Intended Use | Quantitative determination | |
| of HDL Cholesterol | Quantitative determination | |
| of HDL Cholesterol | ||
| Methodology | Homogeneous; Direct | Homogeneous; Direct |
| Reagents | ||
| Reagent 1 | Liquid; Polyanion, Polymer | Liquid; Polyanion, Polymer |
| Volume | 300 uL | 300 uL |
| Reagent 2 (Diluent) | Liquid; Detergent | Liquid; Detergent |
| Reagent 3 (Recon with Rgt 2) | Lyophilized; Enzymes | Lyophilized; Enzymes |
| Volume | 100 uL | 100 uL |
| Specimen | ||
| Type | Serum and Plasma | Serum |
| Volume | 3 uL | 3 uL |
| Assay System | ||
| Reagent 1 + sample | Incubate 300s | Incubate 300s |
| Reagent 3 | Incubate 24 - 300s | Incubate 300s |
| Temperature | 37C | 37C |
| Detection Method | ||
| Type | Spectrophotometric | Spectrophotometric |
| Wavelength, nm | Bichromatic: 546/660 | Bichromatic: 544/692 |
HHDL510K.WPS
-7-
2
Summary of Safety and Effectiveness ACETM HDL-C Reagent
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 | 2 mg/dL to 200 mg/dL | 2 mg/dL to 100 mg/dL |
| Precision | ||
| Within Run | 301 594 5941 |
Page 1 of 1
510(k) Number (if known):_
Device Name:_ACE HDL-C REAGENT
Indications For Use:
This in vitro diagnostic product is intended for the quantitative determination of HDL cholesterol in human serum.
Numerous studies have shown an inverse relationship between serum HDL cholesterol and the risk of coronary heart disease. HDL cholesterol also has an important role in the pathogenesis of atherosclerosis.
signature
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K971526
(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)
: "
Article Carante
OR
Over-The-Counter Use_
(Optional Format 1-2-96)