i-STAT in NICU?

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Hi!

Can anyone share their experience running i-STAT in the NICU? Our NICU is pushing for an i-STAT for Chem8 cartridge testing. We understand that the Chem8 cartridge is not approved for capillary samples, but we have clinicians insisting that they know it is being run at other hospitals. We're unsure if this is outdated information, wishful thinking, testing as LDT, or if some hospitals have some workarounds.

6 Replies

Debra Howard

Mon Apr 13, 2026 at 1:48PM

Hi Teresa,
We do use the ISTAT in the NICU, but they do NOT use Chem8 cartridges. Their cartridge of choice is the CG8+, with the occasional CG4 (for lactate testing) thrown in. The FDA has not cleared capillary blood use on the Chem8, potassium, ionized calcium, or lactates as of yet. It does sound like it will be quite a while before it will be possibly available once again. Through DE, we prevent those results from posting into the EMR. Unfortunately, we cannot block them from being performed without compromising the NICUs ability to run capillary blood at all.

Mary Garcia

Mon Apr 13, 2026 at 2:09PM

We are validating an ISTAT blood gas cartridge for the NICU and plan to block K and iCa for testing. I discussed this issue with capillary testing and faculty was acceptable with the recommendation.

Andries Sigtenhorst

Mon Apr 13, 2026 at 2:28PM

Knowing that there are multiple interpretations, caveats, and such, I decided to ask my friend Copilot to do a little research for me. I asked "Is the Abbott i-STAT Chem 8 cartridge cleared for use with capillary whole blood?" and "What is the CLIA complexity rating for the Abbott i-STAT Chem 8 cartridge?" Here're the responses, minus the attempts to customize for me.

Short answer: No.
The Abbott i‑STAT CHEM8+ cartridge is not FDA‑cleared for routine clinical use with capillary whole blood.

What the cleared labeling actually says

✅ FDA‑cleared specimen types

Abbott’s current Instructions for Use (IFU) and product documentation state that the i‑STAT CHEM8+ cartridge is intended for use with:

Arterial whole blood
Venous whole blood

Capillary whole blood is not listed as an intended specimen type in the cleared IFU. [globalpoin...are.abbott], [globalpoin...are.abbott]

Why capillary blood sometimes shows up in discussions

An older FDA recall notice (2020) referenced capillary specimens in the context of the “BLUE” CHEM8+ cartridges, which were not FDA‑cleared at the time and were the subject of regulatory enforcement action. That notice explicitly instructed facilities to discontinue capillary specimen use for those cartridges. [accessdata.fda.gov]

That mention does not represent current clearance and is not reflected in the active IFU.

Current regulatory position (what surveyors care about)

Specimen type Cleared for CHEM8+? Notes
Venous whole blood ✅ Yes FDA‑cleared
Arterial whole blood ✅ Yes FDA‑cleared
Capillary whole blood ❌ No Not included in current IFU

[globalpoin...are.abbott], [globalpoin...are.abbott]

Compliance impact (important for POCT programs)

Using capillary samples with CHEM8+ would be considered:
- Off‑label use
- Requiring site‑specific validation and
- Likely non‑compliant in a waived or standard POCT environment
Accreditation bodies (CAP, TJC, DNV):
- Expect specimen types to match the manufacturer’s IFU
- Commonly cite capillary use as a POCT deficiency

Recommended documentation language (audit‑safe)

“The Abbott i‑STAT CHEM8+ cartridge is FDA‑cleared for use with arterial and venous whole blood only. Capillary whole blood is not an approved specimen type per the manufacturer’s Instructions for Use.”

Summary answer (the part you usually need for audits and build decisions):

The Abbott i‑STAT CHEM8+ cartridge is CLIA‑moderate complexity overall, with CLIA‑waived status limited to specific analytes and specimen conditions (venous whole blood only).

Detailed CLIA complexity breakdown — Abbott i‑STAT CHEM8+

✅ FDA / CLIA determination

CMS and FDA listings show that the i‑STAT CHEM8+ cartridge (K053110) is categorized as a moderate‑complexity test, with waived designations applied at the analyte + specimen level rather than to the cartridge as a whole. [accessdata.fda.gov]

✅ CLIA MODERATE complexity

Applies to:
- Full CHEM8+ panel use
- Arterial blood
- Non‑waived laboratory settings
Certificate required:
- Certificate of Compliance (CoC) or
- Certificate of Accreditation (CoA)

[cms.gov], [healthcareorigin.com]

⚠️ CLIA WAIVED (conditional / limited)

For venous whole blood only, CMS lists individual analytes on the CHEM8+ cartridge as CLIA‑waived, including:

Sodium
Potassium
Chloride
Ionized calcium
Glucose
BUN
Creatinine
Hematocrit
Total CO₂

[accessdata.fda.gov], [pulseaid.com]

✅ This is why some vendor materials say “CHEM8+ is waived,” while regulatory inspectors may still cite it as moderate complexity — both statements can be technically correct, depending on use.

How this is usually interpreted in practice

Scenario CLIA Complexity CHEM8+ used generically as a cartridge | Moderate
CHEM8+ on venous whole blood only, waived analytes | Waived
CHEM8+ on arterial blood | Moderate
Mixed specimen handling | Moderate

[cms.gov], [accessdata.fda.gov]

Practical guidance (what surveyors expect)

Labs typically license the CHEM8+ as MODERATE complexity to avoid conditional compliance risks.
Waived status does not fully apply if:
- Arterial specimens are used
- Testing goes beyond waived conditions
- Personnel, QC, or validation exceeds CoW limits

✅ Recommended LIS / compliance phrasing

If you’re documenting this for policy, or audit response, the safest language is:

“Abbott i‑STAT CHEM8+ is classified as CLIA‑moderate complexity, with CLIA‑waived status limited to specific analytes when testing venous whole blood per FDA clearance.”

Adil Khan

Mon Apr 13, 2026 at 2:39PM

Hi Tersa,

If this cartridge is not FDA approved for capillary samples then if you are joint commission or CAP accredited it would make it an LDT, meaning you need to do interference testing, ie full validation not verification etc. The clinicians are unaware of all these nuances. This is your strongest counter point.

Adil

----
Adil I. Khan MSc PhD
Professor of Pathology
Medical Director, Point-of-Care Testing
Medical Director, Clinical Chemistry
Temple University Health System

Dept. of Pathology & Laboratory Medicine
Lewis Katz School of Medicine
Temple University
Philadelphia, PA
Tel: 215-707-0965

Cell: 267-908-2114

________________________________

Mary Garcia

Mon Apr 13, 2026 at 2:51PM

The latest Urgent Medical Device Correction from Abbott is below from Aug 2025.

Miranda Cotter

Mon Apr 13, 2026 at 3:41PM

We do not use the ISTAT in the NICU because of the capillary issue. We are moving forward with EPOC. For the time being, we use GEM.

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i-STAT in NICU?