(63 days)
Not Found
No
The summary describes a calibrator, a physical substance used for calibration, and does not mention any computational or algorithmic components, let alone AI/ML.
No
The device is a calibrator for laboratory tests, not a device used for diagnosis, cure, mitigation, treatment, or prevention of disease.
No
This device is a calibrator, used for the calibration of analytical instruments, not for diagnosing diseases or conditions in patients. It provides reference values for lipid methods on automated clinical chemistry analyzers.
No
The device description explicitly states it consists of "liquid human serum with biological materials added," indicating a physical, non-software component.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "For use in the calibration of Roche lipid methods on automated clinical chemistry analyzers." Calibration is a crucial step in ensuring the accuracy of diagnostic tests performed on clinical chemistry analyzers.
- Device Description: The device is a "Calibrator for Automated Systems (C.f.a.s.)" consisting of human serum with added materials. Calibrators are specifically designed to establish the relationship between the signal measured by an analytical instrument and the concentration of an analyte in a sample.
- Context of Use: It is used with "automated clinical chemistry analyzers," which are instruments used to perform in vitro diagnostic tests on patient samples.
- Predicate Device: The predicate device listed (K974825; Roche Diagnostic Calibrator for Automated Systems (C.f.a.s.) HDL/LDL-C plus) is also a calibrator for lipid methods, further supporting its classification as an IVD.
Calibrators are essential components of the in vitro diagnostic process, as they ensure the accuracy and reliability of the results obtained from diagnostic tests.
N/A
Intended Use / Indications for Use
For use in the calibration of Roche lipid methods on automated clinical chemistry analyzers.
Product codes (comma separated list FDA assigned to the subject device)
JIX
Device Description
The Calibrator for Automated Systems (C.f.a.s.) consists of liquid human serum with biological materials added as required to obtain desired component levels. Values for constituent analytes are provided in product labeling.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
K01658
JUL 3 1 2001
510(k) Summary
According to the requirements of 21 CFR 807.92, the following information Introduction provides sufficient detail to understand the basis for a determination of substantial equivalence.
Submitter name, address, contact
Roche Diagnostics Corporation 9115 Hague Road Indianapolis, IN 46250 (317) 576-7643
and the comments of the comments of the comments of the comments of the contraction of the contribution of the contribution of the contribution of the contribution of the con
Contact Person: Helen T. Torney
Date Prepared: May 24, 2001
Device Name
Proprietary name: Calibrator for Automated Systems (C.f.a.s.) Lipids
Common name: C.f.a.s. Lipids
Classification name: Calibrator, Multi-analyte mixture
and the comments of the comments of the comments of the comments of
Device Description The Calibrator for Automated Systems (C.f.a.s.) consists of liquid human serum with biological materials added as required to obtain desired component levels. Values for constituent analytes are provided in product labeling.
1
510(k) Summary, Continued
| Intended use | For use in the calibration of Roche lipid methods on automated clinical
chemistry analyzers. |
|----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Substantial
Equivalence | The Calibrator for Automated Systems (C.f.a.s.) Lipids is substantially
equivalent to other devices legally marketed in the United States. We claim
equivalence to the Roche Diagnostic Calibrator for Automated Systems
(C.f.a.s.) HDL/LDL-C plus (K974825). The intended use of both devices is
the establishment of calibration curves for their respective test systems. |
Substantial equivalence similarities
The following table compares the Calibrator for Automated Systems (C.f.a.s.) Lipids with the predicate device.
| Feature | C.f.a.s. Lipids | C.f.a.s. HDL/LDL-C plus
(Predicate Device) |
|--------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | For use in the calibration of
Roche lipid methods on
automated clinical chemistry
analyzers. | For use in the calibration of
homogeneous Roche methods
for the quantitative
determination of HDL-
cholesterol and LDL-
cholesterol on automated
clinical chemistry analyzers. |
| Format | Pooled human sera with
constituents added as
required to obtain-
component levels. | Pooled human sera with
constituents added as required
to obtain desired component
levels. |
| Stability | Stability of lyophilized
calibrator at 2-8°C. until
expiration date. Stability of reconstituted
calibrator:
8 hours at 15-25°C.
5 days at 2-8°C.
1 month at -20°C. | Stability of lyophilized
calibrator at 2-8°C until
expiration date. Stability of reconstituted
calibrator:
1 day at 15-25°C.
5 days at 2-8°C.
1 month at -20°C. |
| Levels | Single Level | Single Level |
| Matrix | Lyophilized | Lyophilized |
.
2
510(k) Summary, Continued
Substantial equivalence differences
Comparison of proposed Calibrator for Automated Systems (C.f.a.s.) Lipids and predicate device. .
| Feature | C.f.a.s. Lipids | C.f.a.s. HDL/LDL-C plus
(Predicate Device) |
|-------------------------|--------------------|-----------------------------------------------|
| Constituent
Analytes | Apolipoprotein A 1 | HDL-cholesterol |
| | Apolipoprotein B | LDL-cholesterol |
| | Cholesterol | |
| | HDL-cholesterol | |
| | LDL-cholesterol | |
| | Phospholipids | |
| | Triglycerides | |
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three tail feathers, representing the department's commitment to health, human services, and well-being. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUL 3 1 2001
Ms. Helen T. Torney Regulatory Affairs, Laboratory Systems Roche Diagnostics Corporation 9115 Hague Road PO Box 50457 Indianapolis, IN 46250-0457
510(k) Number: K011658 Re: JTO(K) Nambor. 110. Calibrator for Automated Systems (C.f.a.s.) Lipids Regulation Number: 862.1150 Regulatory Class: II Product Code: JIX Dated: May 24, 2001 Received: May 29, 2001
Dear Ms. Torney:
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 to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device microlate commored pror to tray 20, 20, 2011, 2017 11:40 pm
Amendments, or to devices that have been reclassified in accordance with the provisions of the Amendinone, of to avrieosmetic Act (Act). You may, therefore, market the device, subject to r coolar Food, Brag, and Common the Act. The general controls provisions of the Act include the general of 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 (1 remarket rippt of ally in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing i A substantially ogal rates and (GMP) regulation (21 CFR Part 820) and that, through I faction inspections, the Food and Drug Administration (FDA) will verify such penodio GMP mispections with the GMP regulation may result in regulatory action. In assumptions: T andre to oblight further announcements concerning your device in the Federal addition, I Dri may pather sesponse to your premarket notification submission does not affect reeister. Flease noter thave under sections 531 through 542 of the Act for devices under the ally obtigation you inight in Control provisions, or other Federal laws or regulations.
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, (Jease 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 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 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
Indications for Use Statement
510(k) Number (if known): N/A
Device Name: Calibrator for Automated Systems (C.f.a.s.) Lipids
Indications For Use:
For use in the calibration of Roche lipid methods on automated clinical chemistry analyzers.
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
Joan Cooper
(Division ign-Off)
Division of Clinical Laboratory vices
510(k) Number KD11658