(32 days)
Not Found
No
The summary describes a quality control product for immunoassay systems, which is a chemical reagent, not a software or hardware device that would typically incorporate AI/ML. There are no mentions of AI, ML, image processing, or any other indicators of AI/ML technology.
No
The device is described as a quality control product for immunoassay systems, not a treatment or diagnostic tool for a medical condition.
No
Explanation: The device is used for quality control of immunoassays, not for diagnosing diseases or conditions in patients. It helps ensure the accuracy of other diagnostic tests.
No
The device description clearly states it is a "lyophilized product consisting of added antigens in human serum matrix," indicating it is a physical reagent, not software.
Based on the provided information, the Elecsys® PreciControl Universal is an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states it's for "quality control of the Elecsys® immunoassays on the Elecsys® immunoassay systems." Immunoassays are laboratory tests performed in vitro (outside the body) to detect and measure substances in biological samples. Quality control materials are essential components of IVD testing to ensure the accuracy and reliability of the results.
- Device Description: The description mentions it's a "lyophilized product consisting of added antigens in human serum matrix." This is a typical format for IVD quality control materials, designed to mimic patient samples and be used in laboratory settings.
- Predicate Device: The mention of a predicate device (K033937; Elecsys® PreciControl MultiAnalyte) further supports its classification as an IVD. Predicate devices are legally marketed devices that are substantially equivalent to the new device, and they are typically other IVDs.
While the document doesn't explicitly state "In Vitro Diagnostic Device," the intended use, device description, and the context of being used with immunoassay systems for quality control strongly indicate that it falls under the definition of an IVD.
N/A
Intended Use / Indications for Use
Elecsys® PreciControl Universal is used for quality control of the Elecsys® immunoassays on the Elecsys® immunoassay systems.
Product codes
JJY
Device Description
The Elecsys® PreciControl Universal is a lyophilized product consisting of added antigens in 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
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Summary of Performance Studies
The Elecsys® PreciControl Universal was evaluated for value assignment and Performance Characteristics stability.
Key Metrics
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
K 051687
JUL 25 2005
| 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: Corina Harper | |
| Date Prepared: June 22 , 2005 | |
| Device Name | Proprietary name: Elecsys® PreciControl Universal Common name: PreciControl Universal |
| Classification name: Multi-Analyte Controls, All Kinds (assayed and unassayed) | |
| Predicate Device | The Elecsys® PreciControl Universal is substantially equivalent to the currently marketed Elecsys® PreciControl MultiAnalyte (K033937). |
| Device Description | The Elecsys® PreciControl Universal is a lyophilized product consisting of added antigens in 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 the Elecsys® immunoassays on Elecsys® immunoassay systems. |
| Continued on next page |
.
510(k) Summary
1
510(k) Summary, Continued
| Comparison to
Predicate
Device | The Elecsys® PreciControl Universal is substantially equivalent to the
currently marketed Elecsys® PreciControl MultiAnalyte (K033937). The
table below compares Elecsys® PreciControl Universal with the predicate
device, Elecsys® PreciControl MultiAnalyte (K033937). |
| -------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
|---|
Similarities
| Characteristics | Elecsys® PreciControl
Universal | Predicate Device
Elecsys® PreciControl
MultiAnalyte
(K033937) |
|-----------------|----------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Elecsys® PreciControl
Universal is used for
quality control of the
Elecsys® immunoassays
on the Elecsys®
immunoassay systems. | Elecsys® PreciControl
MultiAnalyte is used for
quality control of the
Elecsys® C-Peptide and
Elecsys® Insulin
immunoassays on the
Elecsys® immunoassay
systems. |
| Levels | Two | Same |
| Format | Lyophilized | Same |
Continued on next page
2
510(k) Summary, Continued
| Characteristics | Elecsys® PreciControl
Universal | Predicate Device
Elecsys® PreciControl
MultiAnalyte
(K033937) |
|-----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Handling | Reconstitute with exactly
3.0 mL of distilled water
and allow to stand closed
for 30 minutes to
reconstitute, and then mix
gently. | Reconstitute with exactly
2.0 mL of distilled water
and allow to stand closed
for 15 minutes to
reconstitute, and then mix
gently. |
| Stability | Unopened:
• Store at 2-8°C until
expiration date
Reconstituted (except for
Insulin):
• on the analyzers at 20-
25°C: up to 5 hrs
• 20 - 25°C: up to 8 hrs
• at 2-8°C: 3 days
• at -20°C: 1 month (freeze
only once)
Reconstituted of Insulin:
• on the analyzers at 20-
25°C: up to 5 hrs
• 20 - 25°C: up to 5 hrs
• at -20°C: 1 month (freeze
only once) | Unopened:
• Same
Reconstituted:
• on the analyzers at 20-
25°C: up to 3 hrs
• at -20°C: 1 month (freeze
only once)
• after thawing: use only
once |
... ..........................................................................................................................................................................
Comparison to Predicate Device (continued) - Similarities
Differences
| Characteristics | Elecsys® PreciControl
Universal | Predicate Device
Elecsys® PreciControl
MultiAnalyte
(K033937) |
|-----------------|----------------------------------------------------------------------------------|------------------------------------------------------------------------|
| Matrix | Human serum matrix with
added Antigens (see Table
1: "Matrix Composition") | Equine serum with added
C-Peptide and insulin |
Continued on next page
Roche Diagnostics Confidential
3
510(k) Summary, Continued
The table below lists all active ingredients for Elecsys® PreciControl Matrix Composition Universal.
The active ingredients are spiked into a buffered human serum matrix
| Component | Concentration | |
|---|---|---|
| Reactive Components | AFP (human, cell culture) | please refer to target value |
| sheet of package insert | ||
| Cortisol (synthetic) | ||
| DHEAS (synthetic) | ||
| Estradiol (synthetic) | ||
| Ferritin (human) | ||
| Folate (synthetic) | ||
| FSH (human) | ||
| L-Thyroxin (synthetic) | ||
| hCG (human) | ||
| IgE (human) | ||
| Insulin (human, recomb.) | ||
| LH (human) | ||
| Progesterone (vegetable) | ||
| Prolactin (human) | ||
| Testosterone (vegetable) | ||
| SHBG (human) | ||
| T3 (synthetic) | ||
| TSH (human, recomb.) | ||
| Vitamin B12 (synthetic) |
Table 1
The Elecsys® PreciControl Universal was evaluated for value assignment and Performance Characteristics stability.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure or a bird in flight. The logo is black and white.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUL 25 2005
Ms. Corina Harper, RAC Regulatory Consultant Roche Diagnostics Corporation ... ... 9115 Hague Road Indianapolis, IN 46250
K051687 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 Product Code: JJY Dated: June 22, 2005 Received: June 24, 2005
Dear Ms. Harper:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your because a substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for associated in the Medical Device 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). and Oosmetore, market the device, subject to the general controls provisions of the Act. The r ournal 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 or any I 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
5
Page 2 -
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to ocgin manceling your av revealerse of your device to a legally premarked notification. "The I DA miding of bassance of the and thus, permits your device to proceed to the market. ..
If you desire specific information about the application of labeling requirements to your device, If you desire specific imorination acour tis appears device, please contact the Office of In
or questions on the promotion and advertising of your device the contact of the or questions on the promotion and advertising or your can be and Safety at (240) 276-0484. V Ito Diagnosite Device Devilance and barrey ... (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the You may outlier general miormations on your of the (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Carol C. Benam
Carol C. Benson, M.A. Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
6
Indications for Use
1
$\frac{1}{2} \times 10^{-12}$
510(k) Number (if known):
Device Name:
Elecsys® PreciControl Universal
Indications For Use:
Elecsys® PreciControl Universal is used for quality control of the Elecsys® immunoassays on the Elecsys® immunoassay systems.
Prescription Use XXXX (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) |
|---|
| (Division Sign-Off) |
Division of Clinical Laboratory Devices 510(k) Number KOS 168
Roche Diagnostics Contidential
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