(49 days)
No
The summary describes a quality control product for clinical chemistry analyzers and does not mention any AI or ML components.
No.
The device is a quality control product used for monitoring accuracy and precision in the quantitative determination of various substances in clinical chemistry analyzers, not for treating or diagnosing a disease or condition in a patient.
No
This device is a quality control product used for monitoring the accuracy and precision of quantitative determinations, not for making a diagnosis of a patient's condition.
No
The device description clearly states it is a "two level quality control product prepared from lyophilized human serum," indicating it is a physical product, 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." These are all substances measured in biological samples (like serum) to diagnose or monitor health conditions.
- Device Description: The device is described as "Control Sera prepared from lyophilized human serum." Control sera are used in laboratory tests to ensure the accuracy and precision of the testing process.
- Predicate Device: The predicate device listed (K811832) is also described as "Control Sera," which are a common type of IVD used for quality control in clinical chemistry.
All of these points align with the definition of an In Vitro Diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
N/A
Intended Use / Indications for Use
Roche Diagnostics Precinorm® Universal Plus and Precipath® Universal Plus 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 Plus and Precipath® Universal Plus 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
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)
Reference Device(s)
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
§ 862.1660 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
NOV 2 4 1999
510(k) Summary -- Precinorm® Universal Plus and Precipath® Universal Plus 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: October 4, 1999 |
| Predicate device | Roche Diagnostics Precinorm® Universal Plus and Precipath® Universal Plus 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 Control Sera (K811832) |
| Device description | Roche Diagnostics Precinorm® Universal Plus and Precipath® Universal Plus 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 Plus Control Sera, continued
| Intended use /
Indication for
use | Roche Diagnostics Precinorm® Universal Plus and Precipath® Universal
Plus 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 | 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. |
| Substantial
equivalence -
similarities | The following table compares Precinorm® Universal Plus and Precipath®
Universal Plus Human Serum Controls, with the predicate device (currently
marketed modified Precinorm® Universal and Precipath® Universal Human
Serum Controls.) |
| Characteristic | Precinorm® Universal Plus
and Precipath® Universal
Plus 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 |
Comparison of Modified Device and Predicate Device
2
510(k) Summary – Precinorm® Universal and Precipath® Universal Plus Control Sera, continued
| Characteristic | Precinorm® Universal
Plus and Precipath®
Universal Plus Control
Sera
(Modified Device) | Precinorm® Universal
and Precipath® Universal
Human Serum Controls
(Predicate Device) |
|----------------|--------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 | 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
The new device includes values for additional analytes listed in the table below.
| Additional analytes. | |
|---|---|
| Albumin | Lithium |
| Bicarbonate | Magnesium |
| Gamma globulins | Salicylate |
| Copper | Total iron binding capacity |
| Digoxin | Thyroxine (T4) |
| GLDH | T-Uptake |
| Arylamidase | Unsaturated iron-binding capacity |
Substantial equivalence -differences addition of constitutent analyte values
28
labeling
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized design featuring three abstract shapes that resemble human profiles or flowing lines. The logo is black and white.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Nov 24 1999
Ms. Priscilla A. Hamill Regulatory Affairs, Laboratory Systems Roche Diagnostics Corporation 9115 Hague Road P.O. Box 50457 Indianapolis, Indiana 46250-0457
K993360 Re:
Trade Name: Precinorm® Universal Plus and Precipath® Universal Plus Control Sera Regulatory Class: I Product Code: JJY Dated: October 4, 1999 Received: October 6, 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 (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS 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.
4
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 Sutman
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): NHA K 993360
Device Name: Precinorm® Universal Plus and Precipath® Universal Plus Control Sera
Indications For 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 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 |
2-96)
Rita E. Makin
(Division Sign-Off)
Division of Clinical Laboratory Devices
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