Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a calibrator for clinical chemistry analyzers, which is a standard laboratory reagent used for calibration. There is no mention of AI or ML in the intended use, device description, or any other section. The function is purely chemical calibration, not data analysis or interpretation using AI/ML.

Therapeutic

No
The device is described as a calibrator for automated systems used in clinical chemistry analyzers, not for treating any specific medical condition.

Diagnostic

No

This device is a calibrator, used to calibrate analytical instruments (Roche clinical chemistry analyzers) that perform diagnostic measurements. It is not used to directly diagnose a patient's condition.

SaMD (Software as a Medical Device)

No

The device description explicitly states that the device is a "lyophilized calibrator based on human serum" and "lyophilized calibrator based on bovine serum albumin," indicating it is a physical substance, not software.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states that the device is for the "calibration of quantitative Roche methods on Roche clinical chemistry analyzers." Clinical chemistry analyzers are used to perform tests on biological samples (like serum) in vitro (outside the body) to diagnose or monitor medical conditions. Calibration is a crucial step in ensuring the accuracy of these in vitro tests.
Device Description: The description confirms it's a "lyophilized calibrator based on human serum" or "bovine serum albumin." These are materials used to establish a known reference point for in vitro diagnostic tests.
Intended User / Care Setting: It's intended for use in "clinical chemistry laboratories," which are the typical settings where in vitro diagnostic testing is performed.
Predicate Devices: The listed predicate devices (K062319 and K003158) are also described as "Calibrator for automated systems," further indicating that this type of device is classified as an IVD.

The purpose of a calibrator in this context is to ensure that the results obtained from the clinical chemistry analyzer are accurate and reliable when testing patient samples. This directly supports the diagnostic process, making it an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Calibrator for automated systems (C.f.a.s) is for use in the calibration of quantitative Roche methods on Roche clinical chemistry analyzers as specified in the value sheets.

C.f.a.s. (Calibrator for automated systems) CK-MB is for use in the calibration of Roche methods for the quantitative determination of CK-MB on Roche clinical chemistry analyzers as specified in the value sheets.

Product codes (comma separated list FDA assigned to the subject device)

JIX, JIT

Device Description

C.f.a.s. is for use in the calibration for automated Roche methods on Roche chemistry analyzers as specified in the enclosed value sheet. It is a lyophilized calibrator based on human serum.
C.f.a.s. CK-MB is for use in the calibration of Roche methods for the quantitative determination of the MB Isoenzyme of Creatine kinase on automated clinical chemistry analyzers. It is a lyophilized calibrator based on bovine serum albumin.

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.

K062319, K003158

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

Regulation Number and Section

§ 862.1150 Calibrator.

(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

Summary

0

510(k) Summary – Calibrator for Automated Systems (C.f.a.s.) and C.f.a.s. CK-MB

| Introduction | Roche Diagnostics Corporation hereby submits this 510(k) to provide notification of modifications to our Calibrator for automated systems (C.f.a.s.) and C.f.a.s. CK-MB.

C.f.a.s. was originally cleared for use in K990460, then modified in K033501 and K062319.
C.f.a.s. CK-MB was originally cleared for use in K003158.

Modifications to these devices include changing common source materials for three analytes Human recombinant Gamma-glutamyltransferase (γGT) will replace porcine kidney γGT in C.f.a.s. Human recombinant Aspartate aminotransferase (AST) will replace porcine heart AST in C.f.a.s. Human recombinant Creatine Kinase Isoenzyme MB (CK-MB) will replace porcine brain Creatine Kinase Isoenzyme BB (CK-BB) in C.f.a.s. CK-MB. | |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter name, address, contact | Roche Diagnostics
9115 Hague Rd.
PO Box 50416
Indianapolis, IN 46250
Phone: (317) 521-3380
Fax: (317) 521-2324

Contact Person: Susan Hollandbeck

Roche Diagnostics Calibrator for automated systems
Roche Diagnostics Calibrator for automated systems CK-MB | |
| | Common names:
C.f.a.s.
C.f.a.s. CK-MB | |
| | Classification names:
Calibrator, Multi-analyte mixture
Calibrator, Secondary | |
| | Product Codes:
JIX
JIT | |
| Device
description | 1. C.f.a.s. is for use in the calibration for automated Roche
methods on Roche chemistry analyzers as specified in the
enclosed value sheet. It is a lyophilized calibrator based on
human serum.
C.f.a.s. CK-MB is for use in the calibration of Roche methods
for the quantitative determination of the MB Isoenzyme of
Creatine kinase on automated clinical chemistry analyzers. It
is a lyophilized calibrator based on bovine serum albumin. | |
| Intended use | 1. Calibrator for automated systems (C.f.a.s.) is for use in the
calibration for automated Roche methods on Roche chemistry
analyzers as specified in the value sheets.
C.f.a.s. (Calibrator for automated systems) CK-MB is for use
in the calibration of Roche methods for the quantitative
determination of CK-MB on Roche clinical chemistry
analyzers as specified in the value sheets. | |
| Predicate
devices | We claim substantial equivalence to the following currently marketed
devices.
Calibrator for automated systems cleared in K062319.
Calibrator for automated systems CK-MB cleared in K003158.
Continued on next page | |
| Feature | C.f.a.s
(Modified Device) | C.f.a.s. K062319
(Predicate Device) |
| Intended Use | Calibrator for automated systems
(C.f.a.s.) is for use in the calibration of
quantitative Roche methods on Roche
clinical chemistry analyzers as
specified in the value sheets. | Calibrator for automated systems
(C.f.a.s) is for use in the calibration of
quantitative Roche methods on Roche
clinical chemistry analyzers as
specified in the lot specific value
sheet. |
| Format | Lyophilized | Same |
| Stability | Lyophilized calibrator
2 to 8 °C until expiration date

Reconstituted calibrator
15 to 25 °C for 8 hours
2 to 8 °C for 2 days
-15 to -25 °C for 4 weeks (when
frozen once)

Total Bilirubin in reconstituted
calibrator when stored protected from
light
15 to 25 °C for 6 hours
2 to 8 °C for 1 day
-15 to -25 °C for 2 weeks (when
frozen once)

Continued on next page

ﺯ ۰

1

510(k) Summary – Calibrator for Automated Systems (C.f.a.s.)

and C.f.a.s. CK-MB. Continued

Page 2 of 7

.

Continued on next p

.

. .

1

2

510(k) Summary – Calibrator for Automated Systems (C.f.a.s.) and C.f.a.s. CK-MB, Continued

Tables 1 and 2 compare the features of the modified devices with their Substantial equivalence predicate devices. The first is a comparison of C.f.a.s.; the second is a comparison for C.f.a.s. CK-MB.

Table 1: Comparison of C.f.a.s.

3

510(k) Summary -- Calibrator for Automated Systems (C.f.a.s.) and C.f.a.s. CK-MB, Continued

.

י

Substantial equivalence (continued)

Table 1, continued.

| Feature | C.f.a.s
(Modified Device) | C.f.a.s. K062319
(Predicate Device) |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Traceability | Traceability for each constituent is
described in the reagent system
instructions for use. | Same |
| | Additional Reference Materials

SRM 909b and SRM 956
for Calcium
SRM 929 and SRM 956
for Magnesium
SRM 914 and SRM 967
for Creatinine Jaffe
SRM 909b (IDMS) and SRM 967
for Creatinine Plus
SRM 909b (IDMS) and SRM 1951
for Triglycerides GB | Reference Materials
SRM 909b
for Calcium
SRM 929
for Magnesium
SRM 914
for Creatinine Jaffe
SRM 909b (IDMS)
for Creatinine Plus
SRM 909b (IDMS)
for Triglycerides GB |
| | Reference Material Name Changes
ERM DA470k for Albumin Plus
Primary Reference Material - USP
for Salicylate | Reference Material Names
CRM 470 for Albumin Plus
Primary Reference Material
for Salicylate |
| | Reference Method Publication Update
IFCC (2002), Manual for ALT
IFCC (2002), Manual for AST
IFCC (2002), Manual for CK
IFCC (2002), Manual for LD | Reference Method Publications
IFCC (1985), Manual for ALT
IFCC (1985), Manual for AST
IFCC (1991), Manual for CK
IFCC (1994), Manual for LD |
| Value
Assignment | Values to new lots are assigned by
running them as samples after
calibrating the system with a
previously assigned C.f.a.s. lot.
Values are verified by using reference
material, Master lot C.f.a.s., and
previously assigned lots of C.f.a.s. | Same |
| Source
Material | Human recombinant yGT
Human recombinant AST | Porcine kidney yGT
Porcine heart AST |

4

510(k) Summary – Calibrator for Automated Systems (C.f.a.s.) and C.f.a.s. CK-MB, Continued

Table 2: Comparison of C.f.a.s. CK-MB
Feature	C.f.a.s. CK-MB
(Modified Device)	C.f.a.s. CK-MB K003158
(Predicate Device)
Intended Use	C.f.a.s. (Calibrator for automated
systems) CK-MB is for use in the
calibration of Roche methods for the
quantitative determination of CK-MB
on Roche clinical chemistry analyzers
as specified in the value sheets.	C.f.a.s. (Calibrator for automated
systems) CK-MB is for use in the
calibration of Roche methods for the
quantitative determination of CK-MB
on automated clinical chemistry
analyzers.
Format	Lyophilized	Same
Stability	Lyophilized calibrator
• 2 to 8 °C until expiration date	Lyophilized calibrator
• same
	Reconstituted calibrator
• 15 to 25 °C for 24 hours
• 2 to 8 °C for 2 days
• -15 to -25 °C for 4 weeks (when
frozen once)	Reconstituted calibrator
• 15 to 25 °C for 24 hours
• 2 to 8 °C for 2 days
• -20 °C for 1 month (when frozen
once)
Levels	Single level	Same
Reagent
Composition	Lyophilized calibrator based on
bovine scrum albumin with chemical
additives and material of biological
origin.	Same
Traceability	Traceability for each constituent is
described in the reagent system
instructions for use.	Same
Value
Assignment	Values to new lots are assigned by
running them as samples after
calibrating the system with a
previously assigned C.f.a.s. CK-MB
lot. Values are verified by using
reference material, Master lot C.f.a.s
CK-MB, and previously assigned lots
of C.f.a.s. CK-MB.	Same
Source
material	• Human recombinant CK-MB
• Human CK-MM	• Porcine brain CK-BB
• Human CK-MM

5

510(k) Summary - Calibrator for Automated Systems (C.f.a.s.) and C.f.a.s. CK-MB, Continued

Constituents Tables 3 and 4 catalog the constituent analytes and their biological . source for both the modified and predicate devices. Table 3 summarizes C.f.a.s., a multi-analyte calibrator. For the modified C.f.a.s., the source material changes for two analytes, AST and yGT.

Table 3: Constituents of C.f.a.s.
	C.f.a.s
(Modified Device)	C.f.a.s. K062319
(Predicate Device)
Analyte	Source	Analyte	Source
ALT/ALAT	Porcine heart	ALT/ALAT	Same
AST/ASAT	Human, recombinant	AST/ASAT	Porcine
heart
Albumin	Bovine plasma	Albumin	Same
Alkaline
phosphatase	Human placenta (recombinant)	Alkaline
phosphatase	Same
Amylase, total	Porcine pancreas	Amylase, total	Same
Amylase, pancreatic	Porcine pancreas	Amylase, pancreatic	Same
Bilirubin, direct	Endogenous and/or chemical additive	Bilirubin, direct	Same
Bilirubin, total	Endogenous and/or chemical additive	Bilirubin, total	Same
Calcium	Endogenous and/or chemical additive	Calcium	Same
Cholesterol	Bovine plasma	Cholesterol	Same
Cholinesterase	Human serum	Cholinesterase	Same
Creatine kinase	Rabbit muscle	Creatine kinase	Same
Creatinine	Endogenous and/or chemical additive	Creatinine	Same
yGT	Human, recombinant	yGT	Porcine
kidney
Glucose	Endogenous and/or chemical additive	Glucose	Same
Iron	Endogenous and/or chemical additive	Iron	Same
Lactate	Endogenous and/or chemical additive	Lactate	Same
LD (LDH)	Porcine heart	LD (LDH)	Same
Lipase	Human pancreas (recombinant)	Lipase	Same
Lithium	Chemical additive	N/A1
Magnesium	Endogenous and/or chemical additive	Magnesium	Same
Phosphorus	Endogenous and/or chemical additive	Phosphorus	Same
Salicylate	Chemical additive	Salicylate	Same
Total Protein	Endogenous and/or chemical additive	Total Protein	Same
Triglycerides	Chicken egg yolk	Triglycerides	Same
UIBC	Endogenous and/or chemical additive	UIBC	Same
Urea/BUN	Endogenous and/or chemical additive	Urea	Same
Uric Acid	Endogenous and/or chemical additive	Uric Acid	Same

1 C.f.a.s. was cleared as the calibrator in the Lithium test system in K063684. The source for lithium is the same.

6

510(k) Summary – Calibrator for Automated Systems (C.f.a.s.) and C.f.a.s. CK-MB, Continued

Table 4 summarizes C.f.a.s CK-MB. It is a single analyte calibrator Constituents (continued) that contains two Creatine kinase Isoenzyme sources; CK-MB Isoenzyme is the detected analyte in the test system. For the modified C.f.a.s. CK-MB, the source material changes for one of the two CK Isoenzyme biological additives.

Table 4: Constituents of C.f.a.s. CK-MB

| C.f.a.s. CK-MB
(Modified Device) | | C.f.a.s. CK-MB K003158
(Predicate Device) | |
|-------------------------------------|-------------------------------------------------------------------|----------------------------------------------|---------------------------------------------------------------|
| Analyte | Source | Analyte | Source |
| CK-MB
Isoenzyme | • Human recombinant CK-MB
Isoenzyme
• Human CK-MM Isoenzyme | CK-MB
Isoenzyme | • Porcine brain CK-BB
Isoenzyme
• Human CK-MM Isoenzyme |

7

Public Health Service

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/7/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.

Re:

Food & Drug Administration 903 New Hampshire Avenue Building 66 Silver Spring, MD 20993

Roche Diagnostics c/o Susan Hollandbeck Regulatory Affairs Consultant 9115 Hague Road, P.O. Box 50416 Indianapolis, IN, 46250-0416

8 2010 SEP

K101456 Trade Names: Calibrator for automated systems (C.f.a.s.) Calibrator for automated systems CK-MB (C.f.a.s. CK-MB) Regulation Number: 21 CFR §862.1150 Regulation Name: Calibrator, Multi-Analyte Mixture and Calibrator, Secondary Regulatory Class: Class II Product Codes: JIX, JIT Dated: August 23. 2010 Received: August 24, 2010

Dear Mr. Hollandbeck:

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 class II (Special Controls), 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 (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed

8

Page 2 -

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 Parts 801 and 809), 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 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) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Signature

Courtney C. Harper, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

9

Indications for Use Form

K101456
SEP 08 2010

510(k) Number (if known): k 101456

Device Name:

Calibrator for automated systems (C.f.a.s.)

Indications for Use:

Calibrator for automated systems (C.f.a.s) is for use in the calibration of quantitative Roche methods on Roche clinical chemistry analyzers as specified in the value sheets.

Prescription Use メ (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 OF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Carlos

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K101456

Page 1 of 1

10

Indications for Use Form

510(k) Number (if known): K101456

Device Name:

K101456

SEP 08 2010

Calibrator for automated systems (C.f.a.s.) CK-MB

Indications for Use:

C.f.a.s. (Calibrator for automated systems) CK-MB is for use in the calibration of Roche methods for the quantitative determination of CK-MB on Roche clinical chemistry analyzers as specified in the value sheets.

Prescription Use メ (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 OF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Davis

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K101456

Page 1 of 1