(122 days)
Not Found
No
The summary describes a quality control product for immunoassay analyzers, which is a chemical reagent, not a software or hardware device that would typically incorporate AI/ML. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No.
This device is a quality control product used to evaluate the performance of immunoassay analyzers and is not used for treating or providing therapy to patients.
No.
The device is described as being used for quality control of immunoassays, not for diagnosing a patient's condition.
No
The device description clearly states it is a "lyophilized product consisting of added antigens in a human serum matrix," indicating it is a physical reagent, not software.
Based on the provided information, the Elecsys PreciControl Universal is not an IVD (In Vitro Diagnostic) device itself, but it is a quality control material used with IVD devices.
Here's why:
- Intended Use: The intended use clearly states it's for "quality control of Elecsys immunoassays". Quality control materials are used to verify the performance of diagnostic tests, not to diagnose a condition in a patient.
- Device Description: It's a "lyophilized product consisting of added antigens in a human serum matrix". This describes a control material, not a device that directly measures an analyte in a patient sample for diagnostic purposes.
- Lack of Diagnostic Claims: There are no claims about diagnosing, treating, or mitigating a disease or condition in a patient.
In summary, the Elecsys PreciControl Universal is a crucial component for ensuring the accuracy and reliability of IVD tests (the Elecsys immunoassays), but it is not an IVD device itself.
N/A
Intended Use / Indications for Use
Elecsys PreciControl Universal is used for quality control of Elecsys immunoassays on the Elecsys and cobas e immunoassay analyzers.
Product codes
JJY
Device Description
The Elecsys PreciControl Universal is a lyophilized product consisting of added antigens in a human serum matrix. During manufacture, the analytes are spiked into the matrix at the desired concentration levels.
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)
The Elecsys PreciControl Universal was evaluated for value assignment and stability.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
0
JUL - 2 2009
Elecsys PreciControl Universal
・ 1
510(k) Summary – PreciControl Universal
| Introduction | According to the requirements of 21 CFR 807.92, the following information
provides sufficient detail to understand the basis for a determination of
substantial equivalence. |
|----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter
name, address,
contact | Roche Diagnostics
9115 Hague Road
Indianapolis, IN 46250
317-521-3723
Contact Person: Gail Sauers
Date Prepared: February 27, 2009 |
| Submission
purpose | Roche Diagnostics hereby submits this Traditional 510(k) device
modification to provide notification of changes to our control material,
Elecsys PreciControl Universal (PCU).
PreciControl Universal is used for quality control of Elecsys immunoassays
on the Elecsys and cobas e immunoassay analyzers. This product contains
control material for numerous Elecsys assays in one convenient solution.
Changes to PCU consist of the addition of Carcinoembryonic antigen (CEA)
control and total (free + complexed) Prostate-Specific Antigen (PSA) to
extend the current functionality. |
| Device Name | Proprietary name: Elecsys PreciControl Universal.
Common name: PreciControl Universal
Classification name: Multi-Analyte Controls, All Kinds (assayed and
Unassayed) |
| Device
Description | The Elecsys PreciControl Universal is a lyophilized product consisting of
added antigens in a human serum matrix. During manufacture, the analytes
are spiked into the matrix at the desired concentration levels. |
| Intended use | Elecsys PreciControl Universal is used for quality control of Elecsys
immunoassays on the Elecsys and cobas e immunoassay analyzers. |
| | Continued on next page |
| Predicate
Device | The Elecsys PreciControl Universal is substantially equivalent to the
currently marketed Elecsys PreciControl Universal (PCU) K051687. |
| Device
Comparison | The table below indicates the similarities between the modified Elecsys
PreciControl Universal and the predicate PCU, K051687. |
Image /page/0/Picture/6 description: The image shows the word "Roche" inside of a hexagon with rounded corners. The word is written in a bold, sans-serif font. The hexagon is outlined in black, and the word "Roche" is also in black. The background of the image is white.
· .
1
510(k) Summary – continued
.
Similarities
| Characteristics | Elecsys PreciControl Universal | Predicate Device
Elecsys PreciControl Multianalyte
(K051687) |
|-----------------|-------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Elecsys PreciControl Universal is used for
quality control of Elecsys
immunoassays on the
Elecsys and cobas e
immunoassay analyzers | Elecsys PreciControl
Universal is used for
quality control of the
Elecsys immunoassays
on Elecsys immunoassay
systems. |
| Reagent Format | Same | Lyophilized, based on
human serum in two
concentration ranges. |
| Matrix | Same | Human serum matrix |
| Stability | Same | Unopened:
Store at 2-8°C until
expiration date
Reconstituted (except
for Insulin):
• on the analyzers at 20-
25 °C: up to 5 hrs
• At 2-8°C: 3 days
• At -20°C: 1 month
(freeze only once)
Reconstituted for
Insulin:
• on the analyzers at 20-
25 °C: up to 5 hrs
• 20-25 °C: up to 5 hrs
• at -20: 1 month (freeze
only once) |
Continued on next page
Image /page/1/Picture/6 description: The image shows the Roche company logo. The logo consists of the word "Roche" written in a simple, sans-serif font. The word is enclosed within a hexagon shape, which provides a clear and defined border for the text.
2
510(k) Summary - continued
| continued | Characteristics | Elecsys PreciControl
Universal | Predicate Device
Elecsys PreciControl
Multianalyte
(K051687) |
|--------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|
| | Handling | Same | Reconstitute with
exactly 3.0 mL of
distilled water and allow
to stand closed for 30
minutes to reconstitute,
and then mix gently. |
| Performance | | The Elecsys PreciControl Universal was evaluated for value assignment and | |
| | stability. | | |
| | | The table below indicates the differences between the modified Elecsys
PreciControl Universal and the predicate PCU, K051687. | |
| Characteristics
Device
Comparison
Differences | Characteristics | Elecsys PreciControl
Universal | Predicate Device
Elecsys PreciControl
Multianalvte
(K051687) |
| Differences -
continued | Characteristics | Elecsys PreciControl
Universal | Predicate Device Elecsys
PreciControl
Multianalyte
(K051687) |
| Analyte
Concentration | • AFP (human cell culture) approx. 10-50 IU/ml | • AFP (human cell culture) approx. 10-50 IU/ml | |
| | • Cortisol (vegetable) approx. 359-500 nmol/L | • B12 (synthetic) approx. 1-.5 ng/mL | |
| | • DHEAs (synthetic) approx. 200-500 µg/dL | • Cortisol (vegetable) approx. 13-30 µg/dL | |
| | • Estradiol (synthetic) approx. 100-500 pg/mL | • DHEAs (synthetic) approx. 200-500 µg/dL | |
| | • FSH (human) approx. 10-45 mIU/mL | • Estradiol (synthetic) approx. 100-500 pg/mL | |
| | • fT3 (synthetic) approx. 6-25 pmol/L | • Ferritin (human) approx. 150-30 ng/mL | |
| | • fT4 (synthetic) approx. 12-35 pmol/L | • Folate (synthetic) approx. 12-5.5 ng/mL | |
| | • hCG (human) approx. 5-40 mIU/mL | • FSH (human) approx. 10-45 mU/mL | |
| | • IgE (human) approx. 70-300 U/mL | • fT3 (synthetic) approx. 4-16 pg/mL | |
| | • Insulin, (human, recomb.) approx. 25-80 μU/mL | • fT4 (synthetic) approx. .9-2.7 ng/dL | |
| | • LH (human) approx. 9-50 mIU/mL | • hCG (human) approx. 10-40 mU/mL | |
| | • Progesterone (vegetable) approx. 8-20 ng/mL | • IgE (human) approx. 70-300 U/mL | |
| | • Prolactin (human recombinant) approx. 233-848 µIU/mL | • Insulin, (human, recomb.) approx. 25-80 μU/mL | |
| | • SHBG (human) endogenous | • LH (human) approx. 9-50 mU/mL | |
| | • T3 (synthetic) approx. 2-6 nmol/mL | • Progesterone (vegetable) approx. 8-20 ng/mL | |
| | • T4 (synthetic) approx. 90-170 nmol/L | • Prolactin (human recombinant) approx. 11-40 ng/mL | |
| | • Testosterone (vegetable) approx. 6-2.5 ng/mL | • SHBG (human) endogenous | |
| | • Thyroglobulin * (human) approx. 25-100 ng/mL | • T3 (synthetic) approx. 1.5-4 ng/mL | |
| | • TSH (human) approx. 1-8.5 µIU/mL
• T-Uptake approx. (human) 1-.75 TBI
• CEA (human cell culture) approx. 5-50 ng/mL
• tPSA (human) approx. 1-40 ng/mL
• S100 * (bovine) approx. .2-2.5 ng/mL
- not included in US labeling | • T4 (synthetic) approx. 7-13 µg/dL
• Testosterone (vegetable) approx. 6-2.5 ng/mL
• TSH (human) 1-8.5 µU/mL
• T-Uptake (human) 1.1-.75 TBI | |
Continued on next page
:
3
.
3
510(k) Summary - continued
.
:
4
4
Elecsys PreciControl Universal
. .
.
.
: . . . . . .
the state of the state of the states and s
。 . .
Image /page/4/Picture/9 description: The image shows the word "Roche" inside of a hexagon. The word is written in a simple, sans-serif font. The hexagon is outlined in black, and the word "Roche" is also in black. The background of the image is white.
:
.
.
5
Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Roche Diagnostics ATTN: Ms. Gail Sauers Regulatory Affairs Consultant 9115 Hague Road Indianapolis, IN 46250-0416
JUL - 2 2009
K090541 Re:
Trade/Device Name: Elecsys PreciControl Universal Regulation Number: 21 CFR §862,1660 Regulation Name: Quality control material (assayed and unassayed). Regulatory Class: Class I (Reserved) Product Code: JJY Dated: May 27, 2009 Received: June 02, 2009
Dear Ms. Sauers:
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, 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820).
6
Page 2
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or ( 301 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
CA
Courtney C. Harper, Ph.D. Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
7
Indication for Use
510(k) Number (if known):
Device Name: Elecsys PreciControl Universal
Indication For Use:
Elecsys PreciControl Universal is used for quality control of Elecsys immunoassays on Elecsys and cobas e immunoassay analyzers.
Prescription Use _ X (21 CFR Part 801 Subpart D) . And/Or
Over the Counter Use _ (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Division Sign-Off
notir
Office of In Vitro Diagnostic Device Evaluation and Safety
Evaluation and Safety:
510(k) K096541
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