(86 days)
Not Found
No
The summary describes a quality control product for clinical chemistry analyzers, which is a standard laboratory consumable and does not mention any AI/ML components or functionalities.
No
This device is a quality control product used for monitoring the accuracy and precision of clinical chemistry analyzers, not for treating any condition in a patient.
No.
The device is a quality control product used for monitoring the accuracy and precision of assays, not for diagnosing medical conditions in patients.
No
The device description clearly states it is a "two level quality control product prepared from lyophilized human serum," indicating it is a physical substance, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for "quality control in the quantitative determination of substrates, electrolytes, lipids, enzymes, proteins, and drugs." This involves testing samples in vitro (outside the body) to assess the performance of other diagnostic tests.
- Device Description: The device is described as "lyophilized human serum with addition of constituent analytes." This is a biological material used in laboratory settings for testing.
- Function: The control is used for "monitoring accuracy or precision for manual techniques and assays from Roche on automated clinical chemistry analyzers." This is a classic function of an IVD quality control product, ensuring the reliability of diagnostic results.
The information provided clearly indicates that this device is designed to be used in a laboratory setting to evaluate the performance of diagnostic tests, which is the core definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Roche Diagnostics Precinorm® Universal and Precipath® Universal Control Sera is intended for quality control in the quantitative determination of substrates, electrolytes, lipids, enzymes, proteins, and drugs. The control is used for monitoring accuracy or precision for manual techniques and assays from Roche on automated clinical chemistry analyzers.
Product codes
JJY
Device Description
Roche Diagnostics Precinorm® Universal and Precipath® Universal Control Sera is a two level quality control product prepared from lyophilized human serum with addition of constituent analytes as required to obtain normal and pathological levels.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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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
Not Found
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
510(k) Summary – Precinorm® Universal and Precipath® Universal Control Sera
| 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 Corporation | |
| 9115 Hague Rd | ||
| Indianapolis IN 46250 | ||
| (317) 576 3723 | ||
| Contact person: Priscilla A. Hamill | ||
| Date prepared: August 25, 1999 | ||
| Predicate device | Roche Diagnostics Precinorm® Universal and Precipath® Universal Control Sera is substantially equivalent to other devices legally marketed in the United States. We claim equivalence to the currently marketed Roche Diagnostics Precinorm® Universal and Precipath® Universal Contrail Sera (K811832) | |
| Device description | Roche Diagnostics Precinorm® Universal and Precipath® Universal Control Sera is a two level quality control product prepared from lyophilized human serum with addition of constituent analytes as required to obtain normal and pathological levels. |
1
510(k) Summary -- Precinorm® Universal and Precipath® Universal Control Sera, continued
| Intended use /
Indication for
use | Roche Diagnostics Precinorm® Universal and Precipath® Universal Control
Sera is intended for quality control in the quantitative determination of
substrates, electrolytes, lipids, enzymes, proteins, and drugs. The control is
used for monitoring accuracy or precision for manual techniques and assays
from Roche on automated clinical chemistry analyzers. |
|-----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Substantial
equivalence | Precinorm® Universal and Precipath® Universal Control Sera are equivalent
to other devices legally marketed in the United States. We claim equivalence
to the currently marketed Roche Diagnostics Precinorm® Universal and
Precipath® Universal Human Serum Controls cleared under document
K811832.
The most important modification of the device presented in this submission is
the inclusion of values for additional analytes. Similarities and differences
are presented in detail below. |
2
510(k) Summary – Precinorm® Universal and Precipath® Universal Control Sera, continued
Substantial equivalence similarities
The following table compares Precinorm® Universal and Precipath® Universal Human Serum Controls, with the predicate device (currently marketed modified Precinorm® Universal and Precipath® Universal Human Serum Controls.
| Characteristic | Precinorm® Universal and
Precipath® Universal
Control Sera
(Modified Device) | Precinorm® Universal and
Precipath® Universal
Human Serum Controls
(Predicate Device) |
|----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | For quality control in the
quantitative determination of
substrates, electrolytes, lipids,
enzymes, proteins, and drugs.
The control is used for
monitoring accuracy or
precision for manual
techniques and assays from
Roche on automated clinical
chemistry analyzers. | For control of chemistry
assays. This control material
is well suited for both manual
and automated analytical
procedures. |
| Format | Lyophilized pooled human
sera with constituents added
as required to obtain desired
component levels | Lyophilized pooled human
serum with constituents added
as required to obtain desired
component levels |
| Levels | Two levels | Two levels |
| Stability | • Stable at 2-8° C until
expiration date
• Reconstituted:
✓ 2-8° C - 5 days
✓ 25° - 12 hrs
✓ -20° - 1 month, with
exceptions as noted in
labeling | • Stable at 2-8° C until
expiration date
• Reconstituted:
✓ 2-8° C - 2 days
✓ 10-24° - 8 hrs
✓ -20° - 1 month, with
exceptions as noted in
labeling |
Comparison of Modified Device and Predicate Device
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510(k) Summary – Precinorm® Universal and Precipath® Universal Control Sera, continued
Substantial equivalence differences
The predicate device has been modified to include the additional analytes listed below.
| Additional analytes |
|---|
| Albumin |
| Gamma globulins |
| Copper |
| GLDH |
| Arylamidase |
| Lithium |
| Magnesium |
| Total iron binding capacity |
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its wing. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" surrounding it.
NOV 2 4 1999
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Priscilla A. Hamill Regulatory Affairs, Laboratory Systems Roche Diagnostics Corporation 9115 Hague Road Indianapolis, Indiana 46250-0457
K992900 Re: Trade Name: Precinorm® Universal and Precipath® Universal Control Sera Regulatory Class: I Product Code: JJY Dated: August 25, 1999 Received: August 30, 1999
Dear Ms. Hamill:
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 (OS) 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 at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/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
6
INDICATIONS FOR USE STATEMENT
K992900 510(k) Number (if known): N/A
Device Name: Precinorm® Universal and Precipath® Universal Control Sera
Indications For Use:
For quality control in the quantitative determination of substrates, electrolytes, lipids, enzymes, proteins, i or quality control is used for monitoring accuracy or precision both for manual techniques and assays from Roche on automated clinical chemistry analyzers.
(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) | |
| OR Over-The-Counter Use | |
| (Optional Format 1-2-96) |
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K99290