(12 days)
Not Found
No
The summary describes a quality control product for laboratory testing, not a device that processes data or images using AI/ML. The "Mentions AI, DNN, or ML" section is explicitly "Not Found".
No
The device is described as a quality control product for monitoring the accuracy and precision of quantitative methods, not for treating or diagnosing any medical condition in a patient.
No
The device is described as a quality control product used for "monitoring accuracy and precision for the quantitative methods." It does not directly diagnose a patient's condition but rather ensures the reliability of diagnostic tests.
No
The device description clearly states it is a "quality control product consisting of lyophilized human sera," which is a physical substance, not software.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's "for use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the enclosed value sheet." This clearly indicates it's used in vitro (outside the body) to assess the performance of diagnostic tests.
- Device Description: The description states it's a "quality control product consisting of lyophilized human sera with constituents added as required to obtain desired component levels." This further confirms its use as a control material for in vitro diagnostic procedures.
- Predicate Device: The mention of a predicate device (K993360; Roche Diagnostics Precinorm® U Plus/ Precipath ® U Plus) which is also a quality control product, strongly suggests that this type of device is regulated as an IVD.
The lack of information regarding image processing, AI/ML, imaging modality, anatomical site, patient age, user/setting, and performance studies is typical for a quality control product, as its primary function is to verify the performance of other diagnostic devices, not to directly diagnose or treat patients.
N/A
Intended Use / Indications for Use
Precinorm ® U Plus/ Precipath ® U Plus are for use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the enclosed value sheet.
Precinorm ® U Plus is for use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the enclosed value sheet.
Precipath ® U Plus is for use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the enclosed value sheet.
Product codes (comma separated list FDA assigned to the subject device)
JJY
Device Description
Precinorm ® U Plus/ Precipath ®U Plus is a quality control product consisting of lyophilized human sera with constituents added as required to obtain desired component levels. Concentrations of control components have been adjusted to represent normal and pathological ranges.
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
§ 862.1660 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
Image /page/0/Picture/0 description: The image shows a sequence of handwritten alphanumeric characters. The characters are 'K042389' and are written in black ink on a white background. The characters are slightly distorted, but still legible.
:
SEP 1 4 2004
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 |
|--------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | Proprietary name: Roche Diagnostics Precinorm ® Universal Plus and
Precipath ® Universal Plus Control Sera (Precinorm® U Plus and Precipath
® U Plus) |
| | Common name : Control Sera |
| | Classification name: Multi-analyte controls, all kinds (assayed and
unassayed) |
| Device description | Precinorm ® U Plus/ Precipath ®U Plus is a quality control product
consisting of lyophilized human sera with constituents added as required to
obtain desired component levels. Concentrations of control components have
been adjusted to represent normal and pathological ranges. |
| Intended use | Precinorm ® U Plus/ Precipath ® U Plus are for use in quality control by
monitoring accuracy and precision for the quantitative methods as specified in
the enclosed value sheet |
| | Continued on next page |
1
510(k) Summary - Precinorm ® Universal and Precipath ® Universal Control Sera ,Continued
| Substantial
Equivalence | Roche claims substantial equivalence to the currently marketed Roche
Diagnostics Precinorm® U Plus/ Precipath ® U Plus (K993360). | | |
|------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| Submitter
name, address,
contact | Roche Diagnostics
9115 Hague Road
Indianapolis, IN 46250
(317) 521-3723 | | |
| | Contact person: Theresa M. Ambrose | | |
| | Date prepared: August 18, 2004 | | |
| Substantial
Equivalence –
Device
comparison | The table below compares Precinorm® U Plus/ Precipath ® U Plus with the
predicate device (currently marketed Precinorm® U Plus/ Precipath ® U
Plus). | | |
| Characteristic | Precinorm® U Plus/ Precipath ®
U Plus (Predicate device,
K993360) | Precinorm® U Plus/ Precipath ® U
Plus (Modified Device) |
|----------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | For use in the quality control of
Roche methods for the quantitative
determination of substrates,
electrolytes, lipids, enzymes,
proteins, and selected drugs. The
control is used for monitoring
accuracy or precision both for
manual techniques and assays on
automated clinical chemistry
analyzers. | For use in quality control by
monitoring accuracy and precision for
the quantitative methods as specified in
the enclosed value sheet |
| Format | Lyophilized control serum based on
human serum. Concentrations of
control components have been
adjusted to represent normal and
pathological ranges. | Same |
Continued on next page
2
510(k) Summary - Precinorm ® Universal and Precipath ® Universal Control Sera ,Continued
| Substantial Equivalence - Device comparison (continued) | |||
|---|---|---|---|
| -- | --------------------------------------------------------- | -- | -- |
| Characteristic | Precinorm® U Plus/ Precipath ®
U Plus (Predicate device,
K993660) | Precinorm® U Plus/ Precipath ® U
Plus (Modified Device) |
|----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Stability | Unopened
Until expiration date at 2-8°C | Unopened
Same |
| | Opened/reconstituted:
12 hours at 25 °C
5 days at 4°C
1 month at -20°C when frozen once | Opened/reconstituted:
12 hours at 15-25°C
5 days at 2 to 8°C
4 weeks at -15 to -25 °C when frozen
once |
| | Bicarbonate in reconstituted serum
2 days in closed bottle
1 hour in open bottle
Bilirubin in reconstituted serum
(protected from light)
2 hours at 25 °C
1 day at 4°C
2 weeks at -20°C when frozen once | Bicarbonate in reconstituted serum
Same
Total bilirubin in reconstituted serum
(protected from light)
8 hours at 15-25°C
24 hours at 2 to 8°C
2 weeks at -15 to -25 °C when frozen
once
Direct bilirubin in reconstituted serum |
| | Inorganic phosphorus in
reconstituted serum (protected from
light)
5 hours at 25 °C
1 day at 4°C
1 month at -20°C when frozen once | (protected from light)
4 hours at 15-25°C
8 hours at 2 to 8°C
2 weeks at -15 to -25 °C when frozen
once |
Continued on next page
3
510(k) Summary - Precinorm ® Universal and Precipath ® Universal Control Sera, Continued
| Characteristic | Precinorm® U Plus/ Precipath ®
U Plus (Predicate device,
K993360) | Precinorm® U Plus/ Precipath ® U
Plus (Modified Device) |
|---------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Constituent
Analytes from
biological
additives | • ALT (GPT)
• AST (GOT)
• Albumin
• Aldolase
• Alkaline Phosphatase
• Amylase, total
• Amylase, pancreatic
• Cholesterol
• Cholinesterase
• Creatine kinase
• γ-GT
• GLDH
• LD (LDH)
• Lipase
• Acid phosphatase
• Total Protein | Same |
| Origin of
selected
biological
additives | • Lipase from porcine pancreas
• Albumin and total protein from
human serum | • Lipase from human pancreas
(recombinant)
• For Precinorm® U Plus: albumin
and total protein from bovine serum
• For Precipath ® U Plus: same |
Substantial Equivalence – Device comparison (continued)
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/4/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized human figure with three arms or branches extending upwards. The figure is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA", which is arranged in a circular fashion around the left side of the logo.
SEP 1 4 2004
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Theresa M. Ambrose, Ph.D. RAC Regulatory Affairs Principal Roche Diagnostics 9115 Hague Road PO Box 50457 Indianapolis, IN 46250-0457
K042389 Re:
K042367
Trade/Device Name: Precinorm® Universal Plus Precipath ® Universal Plus Control Sera Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJY Dated: September 1, 2004 Received: September 2, 2004
Dear Dr. Ambrose:
We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Sector 710(x) premainted is substantially equivalent (for the indications referenced above and nave ucterinined the devices marketed in interstate for use stated in the enclosure) to regary manced produced Device Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Edical Federal Food. Drug commerce prior to May 28, 1970, the chacmises with the provisions of the Federal Food, Drug, devices that have been recults in accordance while as proval application (PMA).
and Cosmetic Act (Act) that do not require approval of a provisions of the Act. The and Cosmetic Act (Act) that ao not require approvate of the general controls provisions of the Act. The You may, therefore, market the device, subject to use gentration, listing of
general controls provisions of the Act include requirements for annual mistranding ond general controls provisions of the receiners required in the bronibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is classified (sec above) into entrols. Existing major regulations affecting your device it may be subject to such additional confirent. Basing news 800 to 895. In addition, FDA
can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In can be lound in Title 21, Code of Pederal regulation in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA $ issualles of a successful other requirements of the Act
that FDA has made a determination that your device complies with openaise - You must that FDA has made a delcrimiation that Jour averses by other Federal agencies. You must or any Federal statutes and regulations administered of registration and listing (21 comply with an the Act s requirements, moraling, and good manufacturing practice
CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice CFR Part 807), labeling (21 CFR Parts 60 Pailts (21 CFR Part 820).
5
Page 2
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter while and you to begin mailing of substantial equivalence of your device to a legally premailed notification: "The Pice is a classification for your device 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 destions on the promotion and advertising of your device, please contact the Office of of questions on the promotion and Safety at (301) 594-3084. Also, please note the In Pin o Diagiosao De Horanding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the I ou thay ovant other general mormational and Consumer 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,
Jean M. Cooper, MS, DVM.
Jean M. Cooper, MS, D.V.M. 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
510(k) Number (if known):
Device Name: Precinorm ® Universal Plus and Precipath ® Universal Plus Control Sera
Indications For Use:
Precinorm ® U Plus is for use in quality control by monitoring accuracy and precision for the Frechnorin ® O Fras is ropecified in the enclosed value sheet.
quantitative menods as specifical in the control by monitoring accuracy and precision for the Frecipatii & O Fras is specified in the enclosed value sheet.
X Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 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)
Albert Sontz
Division Sign-Of
Page 1 of 1 __
Office of In Vitro Diagnostia Device Evaluation and Safety
5100k K042387
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